FINEX SIEVES PVT LTD MIKIN SHAH Booth No – E11 Address – 606 GIDC Makarpura, Vadodara, Gujarat- 390010 Country – India Tel – 9825033024 Email – [email protected] Website – www.finexsieves.com Description – Designer and manufacturer of customized powder processing equipments for screening, grinding, mixing, crushing, granulation application and turnkey solution provider Product – Plant / Facility Equipments , Processing Equipments
ACCURATE MACHINES VISHAL SONI Booth No – D16 Address – 422, GIDC Waghodia Waghodia, Vadodara, Gujarat- 391760 Country – India Tel – 91-8511266999 Email – [email protected] Website – www.accurateblister.com Description – Accurate Machines is a leading manufacturer of Blister Packing machines suitable for Pharmaceutical formulations, tablets, capsules, ampoules, vials and injectables. With a state of the art 50,000 sq Ft facility we ensure our customer’s productivity, both by the quality of our products as well as the promptness of service, this has resulted in more than 1000 satisfied customers Globally. Product – Machinery , Packaging Equipment & Supplies , Plant / Facility Equipments
GALAXY SIVTEK PVT. LTD. AKIL MALEK Booth No – E37 Address – Plot No. 1406,GIDC, Waghodia 391 760 Dist : Vadodara, Gujarat. Waghodia. Vadodara, Gujarat391760 Country – India Tel – 91-2668-262970/263170 Email – [email protected] Website – www.galaxysivtek.com Description – Galaxy Sivtek, an ISO 9001 : 2015 company, is leader in manufacturing industrial sieves, separators and filters to achieve high quality products and ensure that your powders, granules and liquids are free from contamination and foreign particles. We also offer genuine after market spares to ensure that your production lines are always running. We have experience of more than 25 years in design, development, manufacture and customization of Vibro separators and have 10000+ successful projects under our belt. Product – Filtration / Separation
GOEL SCIENTIFIC GLASS WORKS LTD. J. N. BHARUCHA Booth No – H28 Address – C/31-A,Sardar Estate GIDC,Ajwa Road, Vadodara, Gujarat- 390019 Country – India Tel – 0265 2561595 Email – [email protected] Website – www.goelscientific.com Description – One of the leading manufacturer and exporter of Borosilicate glass equipment in the world. We specialize in manufacturing of big size laboratory glass ware, R&D glass assemblies, Pilot Plant glass units. Standard distillation units for Research & Development. Also provide overhead glass assemblies above reactors. Manufacturer of rotary evaporators, Nutsche Filters. Specialize in turn-key projects for HCl Gas Absorption, Generation, Solvent Recovery, Bromine Recovery unit, H2SO4 & HNO3 Conc. Units. Product – Custom manufacturing , Laboratory Products and Equipments , Machinery , R&D Units in Borosilicate Glass , Plant / Facility Equipments , Process Automation & Controls , Processing Equipments
LAB SERVICES NIKHIL PATEL Booth No – F15 Address – B-5, Tirupati Nagar, Nr. Utkarsh School, Off Gotri Road, Vadodara, Gujarat- 390007 Country – India Tel – 9825072978 Email – [email protected] Website – www.labservicesindia.com Description – We at Lab Services would like to introduce ourselves as leading company into the business of Manufacturing, Supply & Installation of HVAC System, Laboratory Equipments for Clean Room, Laboratory Furniture & Fume Hoods since its incorporation in the year 1998. Our Products are supplied to all the major government & multinational organizations. We are Master Distributor for Topair Systems, USA, range of clean air products in India. Apart from India, Topair Systems range of non corrosive polypropylene clean air products like Fume Hoods, Clean Bench etc. are supplied to USA, U.K., Italy, Isreal, Singapore, Poland, Philippines, Thailand & UAE. Product – Analytical Equipments , Clean Room Equipments , Laboratory Products and Equipments , Plant / Facility Equipments , Tissue culture medias , Validation
PRETECH AUTOMATION PVT. LTD. SHRIRAM B. SAMPAGAONKAR Booth No – E35 Address – 78 + 79 Tiny Industrial Estate Kondhwa BK, Pune, Maharashtra- 411048 Country – India Tel – 020 26934161/5161 Email – [email protected] Website – www.pretech.in Description – Pretech, Process System , Automation, Panels We are 1996 established Pune & Vadodara based company, having 250+ customers across Globe including Germany, Middle East, South Asia & African Countries. Process System, Turnkey Supply of Skid Mounted Process Plants / Systems / Equipment for Refining Distillation/ Reaction/Crystallization/Solvent Recovery/ Solvent Dispensing/Powder Handling /Single Fluid /Hot Water/ Blending System Etc. Automation & products, Turnkey Projects for Process Control & Industrial Automation with US FDA 21CFR PART11 compline. Dedicated Batch Controllers for API/Bulk Drug/Intermediate manufacturing plants Flame Proof HMI for local user interface. IIOT Solutions. Schneider Electric products Product – Automation and Robotics , Batching Systems / Equipments , Filtration / Separation , Instruments , Process Automation & Controls , Processing Equipments , Purification and separation techniques
RAHUL FERROMET & ENGG. PVT. LTD. RUPJYOTI HALOI Booth No – C24 Address – 609, Sanket Heights, Nr. Akshar Chowk, Sun-Pharma Road, Vadodara, Gujarat- 390020 Country – India Tel – 0265-2981100 Fax – 0265-2982200 Email – [email protected] Website – www.rensatubes.com Description – Rensa Tubes & Fittings is a brand name for Hygienic tubes Manufactured by Rahul Ferromet and Eng. Pvt Ltd. We consider ourselves as one of the leading service providers for Hygienic and Ultra High purity electro polished and mechanical polished stainless steel tubes for more than 15 years. rensa Tubes has set up the world class manufacturing facility to cater to Pharma, Bio-Pharma, Health care Food & Beverage and Dairy Market. Product – Active Pharmaceutical Ingredients , Biochemicals , Biotechnology , Clean Room Equipments , Plant / Facility Equipments , Processing Equipments
RUSSELL FINEX SIEVES AND FILTERS PVT LTD. KUMAR SAURABH Booth No – E30 Address – Plot No. F-27, Ground Floor, BIDC Estate, Gorwa, Vadodara, Gujarat – 390016 Country – India Tel – 8928063881 Email – [email protected] Website – http://www.russellfinex.in/ Description – Russell Finex Sieves & Filters Pvt Ltd. designs and manufactures sieving and filtration equipment for the processing industries. The companyâ€™s products include check screening machines, grading sieving machines, liquid solid separation equipment, ultrasonic sieve deblinding systems, and self-cleaning filters for liquids. It also offers a range of services, spares, and upgrades. The company serves food and beverage, pharmaceuticals, coatings, chemicals, ceramics, metal powders, water processing, and recycling industries. Product – Custom manufacturing , Filtration / Separation , Laboratory Products and Equipments , Plant / Facility Equipments , Purification and separation techniques
SUPER SCIENTIFIC WORKS PVT. LTD. ASHISH GOYEL Booth No – G07 Address – D 34 / E 70 71, Sardar Estate, Ajwa Road, Vadodara, Gujarat- 390019 Country – India Tel – 0265 2512088 Email – [email protected] Website – www.superscientific.com Description – Super Scientific Works Pvt. Ltd is a leading manufacturer and exporter of â€“ (1) Borosilicate Glass Process Equipments (2) Fluoro Polymer Lined Pipes, fittings & valves (3) Pure PTFE molded & machined products (4) Anti corrosive Industrial Coatings Applicator All the products we manufacture are as per the international standards of quality. We enjoy trust and satisfaction of over 500 reputed clients across globe from various industrial sectors. Our strong legacy of over 35 years since our establishment in 1982 has helped us to become market leader in products we supply. Product – Laboratory Products and Equipments , Fluoro Polymer Lined Pipes, Fittings and Valves , Plant / Facility Equipments , Processing Equipments
AZTEC PROCESS AUTOMATION (P) LTD. SUBBARAO V KATTAMURI Booth No – C21 Address – 5th & 4th Floor, TP House, Beside Carwash, Jaihind Enclaves, Jaihind road, Madhapur, Hyderabad, Telangana- 500081 Country – India Tel – 040 40638200 Email – [email protected] Website – www.aztec-consult.com Description – Aztec is a manufacturing and information management firm founded by industry experts, for industry experts. Our team is comprised of consultants with experience both leading and executing projects in the industries we serve. As a result, we design and implement our projects with a strong understanding of what our clients need and with their best interest in mind. We are proven in Global top 10 Pharmaceutical and Water/Wastewater firms delivering projects ranging from industrial control and automation to enterprise systems (i.e. LIMS, CAPA, and CMMS) and services including project management, design, implementation, and validation. Product – Consulting services , Process Automation & Controls
ECOBLISS INDIA PVT. LTD. ABHISHEK ARUMILLI Booth No – E07 Address – # 817, Manjeera Majestic Commercial, KPHB, Hyderabad, Telangana- 500072 Country – India Tel – 040 4270 3663 Email – [email protected] Website – www.ecobliss.com Description – Ecobliss, a global leader in field of packaging, was established with an aim of providing innovative packaging solution and high visibility packaging. Our unique and innovative cold seal technology, is a robust, simple, easy to use and ecofriendly way of packaging helped us to provide innovative packaging solutions like unique physicianâ€™s samples, blister cards, blister cartons, wallets, dose packs (single/ multiple dose packs), child resistant packaging, etc. to the pharmaceutical and healthcare industry. At Ecobliss, we also offer range of other packaging solutions like mono cartons, fluted cartons, technical blisters, blister trays, transparent boxes, contract packings and various packaging machinery. Our team of skilled and packaging professionals will help you to provide right packaging solution for your needs from stage of development, realization and implementation throughout the entire process. Product – Blister Packaging/ Pharmacutical packaging/ cartons/ Packaging Machinery
INTEGRATED CLEANROOM TECHNOLOGY PVT. LTD. B GOPAL REDDY Booth No – F06 Address – 201, Sree Vensai Towers Varuna Block Kompally, Hyderabad, Andhra Pradesh- 500014 Country – India Tel – 91-40-27165311 Email – [email protected] Website – www.icleantech.com Description – Integrated Cleanroom Technologies Pvt Ltd (ICLEAN) a group Company of Takasago Thermal Engineering(TTE), Japan is the leading Cleanroom Manufacturer from India, providing total cleanroom solution on turnkey basis. ICLEAN is a one stop solution provider for design, manufacture, installation, commissioning & validation of complete modular cleanrooms along with seamlessly integrated HVAC system. Product list include Cleanroom Accessories, Lab Furniture, Fume hoods, Air Handling Units including HVAC, BMS, and Electrical etc. For more details please refer our website www.icleantech.com Product – Clean Room Equipments , Laboratory Products and Equipments , Turnkey Cleanroom Solutions
MORESCHI ASIA DOORS PVT. LTD. SIVAKRISHNA KOTHURU Booth No – B21 Address – Plot 6, Shed 2, IDA Bollaram, Miyapur, Hyderabad, Telangana- 502325 Country – India Tel – +91-7032820763 Fax – 08458279790 Email – [email protected] Website – www.moreschisrl.com Description – Moreschi Doors is an European company setup with fully fledged operations in manufacturing industrial doors at Hyderabad, India. It is a Group company of MoreschiSrl-Italy. MoreschiSrl has 50 years of experience, technology and continuous innovation to be a successful top company in the market and leaders in European markets. Moreschi Doors modern technology setup to manufacture and service the Indian and Asian markets. We manufacture Industrial Folding Doors & Sliding Doors, Rapid Roll up Doors & Rapid Fold up Doors, Insulated Rolling Shutters. Applications of our Products: AirCraft Hangars,Automobile,Engineering Industry,Food Industry,Healthcare,Industrial Production Areas, Logistics, Pharmaceuticals, Ship Industries, Ware Houses. Product – Industrial Doors
NICOMAC CLEAN ROOMS FAR EAST LLP RAMESH G Booth No – A20 Address – Plot No-116 , I.D.A Bollaram, Near Miyapur,Hyderabad, Telangana- 502325 Country – India Tel – +91-9515192020 Email – [email protected] Website – www.nicomac.com Description – Nicomac Clean Room System is most advanced Technology for Pharmaceutical, API, Biotechnology, Food & Electronic Industries .We offer Clean Room Panels, Doors, Windows& False Ceilings. We offer HPL, PCGI, PPGI, SS, GRP & insulations of PUF, PIR Rockwool& Honeycomb. We combine our top quality product with skilled installation crew. High Quality, Attractive appearance & competitive price. Only first class materials are used, high quality finishes are applied on all surfaces. Nicomac is one of the most modern and efficient Clean Room plant in Asia, manufactures according to International QA & safety standards with European and Japanese machinery. Product – Clean Room Equipments , Clean Room Moudlar System
PHARMA ENGINEERS PULLA REDDY KOPPULA Booth No – D34 Address – Plot No 113/A/1 , Lane No 8, Phase II, IDA Cherlapally, Hyderabad, Telangana- 500051 Country – India Tel – 040 27261114/27261113 Email – [email protected] Website – www.pharmaengineers.com Description – Pharma Engineers, are one of the leading companies involved in the Design, Manufacture, Supply and Service in the field of Pharmaceutical HVAC and Turnkey Solutions. Catering to a spectrum of Pharmaceutical Industries involving Formulations, Sterile and Biotech Industries. Research and clean room facilities Products manufactured are customised, efficient and performance oriented like Pharma Grade AHUs with Manifolds, Prefabricated Ducting, Pre & Fine Filters, Dynamic/Static Pass box, Dispensing booth, Hot water Generators, Ceiling Suspended LAF, Vertical LAF, Mobile LAF, Mist Showers and Terminal Modules etc., Pharma Engineers are also rated as one of the best service provider in INDIA Product – Clean Room Equipments , Consulting services , Custom manufacturing , Laboratory Products and Equipments , Machinery , HVAC , Plant / Facility Equipments
POLMON INSTRUMENTS PRIVATE LIMITED TAJAMMUL HUSSAIN Booth No – G49 Address – Polmon House Nizampet Road Kukatpally, Hyderabad, Telangana- 500072 Country – India Tel – 040-23053046 Email – [email protected] Website – www.polmon.com Description – Polmon provides Process Automation and Instrumentation Solutions to Life Sciences Industry, particularly the Pharmaceutical Industry.. Polmon has following divisions: 1. Instruments 2. Automation 3. Single Fluid Heat Transfer Systems 4. Services 5. Medical Devices. For more information please visit www.polmon.com Product – Automation and Robotics , Clean Room Equipments , Instruments , Process Automation & Controls , Validation
SMART LABTECH PVT. LTD. P. V. SATYA PRASAD Booth No – G45 Address – Plot #75B, Sy#735, SV Co-op Industrial Estate, Balanagar, Phase-2, Hyderabad, Telangana- 500037 Country – India Tel – 040 23774310 Fax – 040 23774309 Email – [email protected] Website – www.smartlabtech.net Description – Smart Labtech, a premier supplier of Laboratory, Analytical, Biotechnological, Environmental, Microscopy and Weighing Equipment suitable for different applications. SMART LABTECH has products such as Weighing Balances, Incubators, Ovens, Vacuum Ovens, Water Baths, Stability Chambers, Microscopes, Spectrophotometer, Gas Chromatography, NIR, FTIR, Deep Freezers, Colony Counters, Centrifuges, Microbiological Products, Melting Point, Columns, Platform Balances, XRD/XRF, ICP/ICP-MS, HPLC, Viscometers, 3D Laser Scanners, Furnaces, Stirring Line, pH&Conductivity meters , Autoclaves, etc., Product – Analytical Equipments , Instruments , Laboratory Products and Equipments , Purification and separation techniques , Tablet disintegrants , Testing and Measurement
Company Names of Manufacturers & Exporters of Laboratory & Scientific Equipment
Accrual Pharma Pack LLP B Accupack Engineering Pvt Ltd C Accura Pharmaquip Pvt Ltd D Accurate Machines D ACD Machine Control Co. Pvt. Ltd. A Aditya Chemicals I AGARAM Industries G Airtech Systems India Pvt. Ltd. G Allegro Pharmachem Equipments A Allyone Industries G Ambica Engineering Works A Amkette Analytics Ltd H Analytical Technologies Limited F Anton Paar H Anvay Pharma Systems Pvt. Ltd. B APEX CHROMATOGRAPHY PVT. LIMITED F Aril Pharmaceuticals J Armacell India Pvt. Ltd. E Autocal Solutions Pvt. Ltd. F Autopack Industries D Avcon Controls Pvt. Ltd. B Avians Innovations Technology Pvt. Ltd. G Avon Pharma Machines Pvt. Ltd. B Aztec Process Automation (P) Ltd. C Bazaz Publications F Belimo Actuators India Pvt. Ltd. F Bio Clean Integrated Air System Private Limited C Biolinx India Private Limited F BITZER India Pvt. Ltd. D Bliss-ca Technologies A B.M Scientific F Borosil Glass Works Ltd. F Brilliant Process Machinery Pvt. Ltd. F BRK Instruments India LLP H Bruker India Scientific Pvt. Ltd. F Bry-Air (Asia) Private Limited F Casilica Dehumidifiers F Cintex Industrial Corporation H Condot System Pvt Ltd C Contech Instruments Limited G Control Print Limited B CU-V-KAR Genetics I Cyklop Packaging Systems (I) Pvt Ltd. C Dandong Bettersize Instruments Ltd. H Design Centre B DHV Fitting Pvt. Ltd. A Dockweiler AG E Domino Printech India LLP B Dry Air India Pvt. Ltd. E & E Comapany Name Booth No. Dumra Machines C Durva Machinery E Ecobliss India Pvt. Ltd. E Elementar India Pvt. Ltd. H ELGI Equipments Limited C Elmach Packages (India) Pvt Ltd C Esico International H A Expert Vision Labs Pvt. Ltd. H Express Pharma F FabLab Engineering India Pvt Ltd C Fabtech Pharma C Falcon Machineries E Finex Sieves Pvt Ltd E First Source Laboratory Solutions F FLIR Systems India Pvt. Ltd. F Galaxy Sivtek Pvt. Ltd. E GALLEON INSTRU-TECH PVT LTD F Gandhi Automations Pvt. Ltd. A Gangwal Chemicals Pvt. Ltd. J Gem Pharma Machineries B Global Packaging D Global Vision (Pharma Machines and Technology) F GMP Technical Solutions Pvt. Ltd F Goel Scientific Glass Works Ltd. H G T Metals & Tubes A Hangzhou Tianshan Precision Filter Material Co., Ltd. F Harsiddhi Pharma Equipments E Helios Concrew Pvt. Ltd. C Hiten Techno Products Corporation HMG India F Hoong-A Corporation A Hugopharm Technologies Private Limited E Hygro Tech Engineers G I R Technology Services Pvt. Ltd. F Idealin Fogging Systems F Imageprovision Technology Private Limited G Indu IonPure India Pvt. Ltd. D Inos Technologies Pvt. Ltd. D Integrated Cleanroom Technology Pvt. Ltd. F Jetspray Innovations Private Limited A J-Sil Trading Corporation H June Enterprises Pvt. Ltd. E Jupiter Integrated Sensor Systems Pvt. Ltd. A A Kaeser Compressors India Pvt. Ltd. C Kambert Machinery Co. Pvt. Ltd. C Khosla Profil Pvt. Ltd. A Kirloskar Pneumatic Company Limited B Kitten Enterprises Pvt Ltd B Accrual Pharma Pack LLP
Kongposh Publications Pvt. Ltd. (The Pharma Review) F L&P Global Inc. D Lab Services F Labindia Instruments Pvt. Ltd. H Lablink H Labtop Instruments Pvt. Ltd. G Leistung Engineering Pvt. Ltd. A Mack Pharmatech Pvt. Ltd. G Mahati Polymer Corporation E Mark Vi Trac Systems E Mascon Techneeds E & E Masibus Automation And Instrumentation Pvt. Ltd. G Maxcare Device E Mec-Well Pharma Machinery Pvt Ltd B Measuretest Instruments F Mechmaark Filtech India Pvt. Ltd. H Microbioz India – The Magazine F Micronclean Ltd. F A Mistry Engineering A Mistry Packtech Engineering E Moreschi Asia Doors Pvt. Ltd. B Naturon Healthcare Limited D Netfil Technik Pvt. Ltd. D Nexgen Pharmatech B A Nicomac Clean Rooms Far East LLP A NIHVA Technologies Pvt. Ltd. C NPM Machinery Pvt Ltd. D Ohmkar Equipments F Om Industries B Omega Scientific Instruments Pvt Ltd D Osworld Scientific Equipments Pvt. Ltd. A Pacific Tools Pvt. Ltd. E Pacmac Solution Pvt. Ltd. B Perkinelmer (India) Pvt. Ltd F PHARMA ENGINEERS D Pharma Mech Machineries E Polmon Instruments Private Limited G Powerjet Engineering LLP B PRETECH Automation Pvt. Ltd. E Prudence Pharma Chem I PT Electronics Pvt. Ltd. E Rahul Enterprises A Rahul Ferromet & Engg. Pvt. Ltd. C Rattan Filters & Exporters Pvt. Ltd. E Rehoboth Enviro Systems D Remi Elektrotechnik Limited G Renessen Packages Private Limited A Roop Telsonic Ultrasonix Ltd. D Rotarex F Comapany Name Booth No. Russell Finex Sieves and Filters Pvt Ltd. E S.K. Pharma Machinery Pvt. Ltd. A Sachin Industries Ltd. D Saffron Media (Chronicle Pharmabiz) F Saimach Pharmatech Pvt. Ltd. B Saksham Analytical Instruments Pvt. Ltd. G Sanitt Equipment & Machines P. Ltd. A Sartorius India Pvt. Ltd. F Schott Kaisha Private Limited B Scientific Research Instruments Company Private Limited H Shah Brothers B Sharad Micro Die & Engg. Works B A Shimadzu Analytical (I) Pvt. Ltd. F Shredders and Shredding Co. C Shreenath Enterprise D SIGMA GROUP OF COMPANIES C Smart Labtech Pvt. Ltd. G Sophisticated Analytical Instrument Facility(SAIF) G SpectrumPharmaTECH Consultants Pvt. Ltd. B Spinco Biotech Pvt. Ltd. F Spraytech Systems India Pvt. Ltd. A Suntec Teknopak Cleanrooms & Containments E Super Scientific Works Pvt. Ltd. G Svan Analytical Instruments Pvt Ltd. F Swati Spentose Pvt. Ltd. I Techbio Solutions F Technovalue Solutions Pvt. Ltd. G Techline Industries C Tempo Instruments Pvt. Ltd. G Tempsens Instruments (I) Pvt. Ltd. G Tex Mech Engineers D The Bombay Engineering Works A Thermolab Scientific Equipments Pvt Ltd F Titan Biotech Ltd. H Top Syringe Mfg. Co. Pvt. Ltd. G A TOPSE Process Solutions Pvt. Ltd. D Toshvin Analytical Pvt. Ltd. G Trio India A Unichrome Associates H Utopia Optovision Pvt. Ltd. C Valfit Process Equipment Pvt. Ltd. A Valiant Pharma Equipments A Vignesh Lighting Technologies F Watermass Systems Pvt. Ltd. A Welch Materials India Pvt. Ltd. H Xpert Scientific Pvt. Ltd. H Xin Weisheng C
ADITYA CHEMICALS DUSHYANT ANSODARIA Booth No – I Address – / , Ajanta Estate, At Vasna-Iyava, Tal Sanand, Ahmedabad, Gujarat- Country – India Tel – Email – [email protected] Website – http://www.adityachemicals.in/
AIRTECH SYSTEMS INDIA PVT. LTD. SUMEET AGGARWAL Address – & ,Satellite Silver,andheri kurla road, Above Kotak Mahindra Bank, Marol Naka, Andheri (East), Mumbai, Maharashtra- Country – India Tel – – – Email – [email protected] Website – www.airtechsys.in
AVON PHARMA MACHINES PVT. LTD. SHAHID KAMAL Address – Unit no. , Mona Industrial Estate no. Behind Tirupati Udyog Nagar Sativali, Vasai (East), Thane, Maharashtra- Country – India Tel – – – Email – [email protected] Website – www.avonpharmamachines.com
BITZER INDIA PVT. LTD. MILI SAVANI Address – R- / , TTC Industrial Area, Rabale, Navi Mumbai, Maharashtra- Country – India Tel – ext Email – [email protected] Website – www.bitzeravp.com
CASILICA DEHUMIDIFIERS VAIBHAV GUPTA Address – / b Gwalior House Rajpur Road Civil Lines Delhi- Country – India Tel – – Email – [email protected] Website – www.casilica.com
DANDONG BETTERSIZE INSTRUMENTS LTD. SUN LIN Address – No. , Ganquan Road, Jinquan Industrial Park, Dandong, Liaoning- Country – China Tel – Email – info @bettersize.com Website – www.bettersize.com.hk
CONDOT SYSTEM PVT LTD MANISHA RATHOD Address – Unit no. , Niraj Indl Estate Behind Paper Box, Off. Mahakali Caves Road Andheri (East), Mumbai, Maharashtra- Country – India Tel – – – Email – [email protected] Website – www.condotsystems.com
ECOBLISS INDIA PVT. LTD. ABHISHEK ARUMILLI Address – # , Manjeera Majestic Commercial, KPHB, Hyderabad, Telangana- Country – India Tel – Email – [email protected] Website – www.ecobliss.com
ELGI EQUIPMENTS LIMITED BALAMURUGAN KALAIMANI Address – ELGI Industrial Complex, Trichy Road, Singanallur, Coimbatore, Chennai- Country – India Tel – Fax – Email – [email protected] Website – www.elgi.com
ESICO INTERNATIONAL MOHIT GUPTA Booth No – H A Address – Tower Wali Building, Opp.Sec- Vill-Kamli, Parwanoo, Himachal Pradesh- Country – India Tel – Email – msei @yahoo.com Website – http://www.esicointernational.com/
EXPERT VISION LABS PVT. LTD. BHANU RATAN Booth No – H Address – , Anandi Bldg, Dr. M.B. Raut road, Opp. Bal Mohan School, Dadar (W), Mumbai, Maharashtra Country – India Tel – Email – [email protected] Website – www.expertvisionlabs.com
EXPRESS PHARMA RAJESH BHATKAL Booth No – F Address – st Floor,Express Towers, Nariman point,- ,Mumbai, Maharashtra- Country – India Tel – Email – [email protected] Website – www.expressbpd.com/pharma/
FIRST SOURCE LABORATORY SOLUTIONS MADHAVI CHAGANTI Booth No – F Address – # , Nimishamba Arcade, nd Floor , rd Cross, arekere Mair Road, Bannerghatta Road, Bangalore, Karnataka- Country – India Tel – Email – [email protected] Website – http://www.firstsourcels.com/
FINEX SIEVES PVT LTD MIKIN SHAH Booth No – E Address – GIDC Makarpura, Vadodara, Gujarat- Country – India Tel – Email – [email protected] Website – www.finexsieves.com
GANDHI AUTOMATIONS PVT. LTD. Y. N PATEL Booth No – A Address – Chawda Commercial Centre, Link Road, Malad (W), Mumbai, Maharashtra- Country – India Tel – + / Fax – + Email – [email protected] Website – www.geapl.co.in
GALLEON INSTRU-TECH PVT LTD VAIBHAV SARANG Booth No – F Address – M- , Neighborhood Complex Near State Bank Of India, Nerul Navi Mumbai, Maharashtra- Country – India Tel – Email – [email protected] Website – http://www.galleoninstru-tech.com/
Pharma QA Interview Question And Answer are here presented for you to help you to crack Quality Assurance Interview in Pharmaceutical manufacturing companies. Definition Of Quality Assurance along with its use In Pharma Industry are listed here below.
Quality Assurance Pharma Interview Questions – Part 1
Sample QA Interview Question: Define quality assurance Ans) QA is a broad range of concept contains all the matters that individually or collectively effect the quality of a product. QA mainly concentrated on planning and documenting the procedures to assure the quality of the product.
Sample QA Interview Question: What needs to be checked during inprocess QA checks? A. a.) Environmental Monitoring b.) Measured values obtained from the process equipment (ex:temperature,RPM etc.) c.) Measured values obtained from persons (ex:timmings,entries etc.) d.) Process attributes (Ex:weight,hardness,friability etc.)
Sample QA Interview Question: What precautions shall be taken while collecting inprocess samples ? A. While collecting inprocess samples, avoid contamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken.
Sample QA Interview Question: In a tablet manufacturing facility ‘positive’ pressure is maintained in processing area or service corridors? A. In tablet manufacturing facilities, pressure gradients are maintained to avoid cross contamination of products through air. Usually processing areas are maintained under positive pressure with respect to service corridors.
Sample QA Interview Question: If sticking observed during tablet compression what may the probable reason for the same? A. 1.If the granules are not dried properly sticking can occur. 2.Too little or improper lubrication can also leads to sticking. 3.Sticking can occur because of too much binder or hygroscopic granular.
Sample QA Interview Question: What checks shall be carried out, while calibrating DT apparatus? A. While calibrating DT apparatus, following checks shall be performed. 1.) Number of strokes per minute (Limit:29-32 cycles/min) 2.) Temperature by probe & standard thermometer (Limit: 37 ± 1 OC). 3). Distance travelled by basket (Limit:53 -57mm)
Explain the difference between QC and QA?
Ans) QA provides the confidence that a product will full fill the quality requirements. QC determines and measures the product quality level.
QA Interview Question: . Expand cGMP and what is the difference between GMP and cGMP?
Ans) cGMP known as Current Good Manufacturing Practices. It is a USFDA regulations to assure proper design , manufacturing and control of manufacturing processes and services.
GMP-Good Manufacturing Practices. These are the standard guidelines given by Food and Drug administration to make sure that a product is manufactured with safety and quality. c in cGMP means current. It refers to recent and advance updates to these standard guidelines. cGMP is up to date standard reference guidelines.
Sample QA Interview Question: What is In process checks? A. In process checks are checks performed during an activity,In order to monitor and,if necessary,to adjust the process to ensure that product confirms to its specification.
Sample QA Interview Question: What is the difference between disintegration and dissolution? A. Disintegration is a disaggregation process, in which an oral dosage form falls apart in to smaller aggregates.(Disintegration time is the ‘break up’ time of a solid dosage form).
Where as dissolution is a process by which solid substance enters in the solvent to yield a solution.It is controlled by the affinity between the solid substance and the solvent.
In other word disintegration is a subset of dissolution.
Sample QA Interview Question: Why do we calibrate a qualified equipment/instrument on definite intervals? A. An equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use.So it is recommended to calibrate and recalibrate the measuring devices and instruments on predetermined time intervals, to gain confidence on the accuracy of the data.
Pharma Quality Assurance Interview Q&A: What is room temperature?
Ans) 25 degree centigrade
Pharma Quality Assurance Interview Q&A: What is the Ultraviolet(UV) and visible spectroscopy range?
Ans) UV spectroscopy range 200-400 nm, Visible spectroscopy range 400 nm to 800nm.
Pharma Quality Assurance Interview Q&A: What is the use of UV Spectroscopy?
Ans) Spectroscopy used for detecting the functional groups, impurities. Qualitative and quantitative analysis can be done.
Pharma QA Job Interview Guide Part 2
Sample QA Interview Question: What is the difference between qualitative and quantitative analysis?
Ans) Qualitative analysis involves identification of the compound or chemical based on their chemical(absorption, emission )or physical properties(e.g Melting point, boiling point).
Quantitative analysis involves estimation or determination of concentration or amount of the chemical compounds or components.
Q5) Explain the principle of Ultraviolet spectroscopy?
Ans) UV spectroscopy uses light in the UV part of electromagnetic spectrum. UV absorption spectra arises in which molecule or atoms outer electrons absorb energy, undergoes transition from lower energy level to higher energy level. For each molecule, absorbance at wavelength is specific.
Q6) Explain about Beer Lamberts law?
Ans) It states that the intensity of monochromatic light absorbed by a substance dissolved in a fully transmitting solvent is directly proportional to the substance concentration and the path length of the light through the solution.
Q7) Explain the Infrared spectroscopy principle?
Ans) When a molecule absorbs the Infrared radiation, it vibrates and gives rise to packed Infrared(IR) absorption spectrum. This IR spectrum is specific for every different molecule absorbing the IR radiation, useful for its identification.
Q8) What is the body temperature?
Ans) 37 oCelsius or 98.6 oF
v Define pH? What is the pH of blood? Ans) pH -Negative logarithm of hydrogen ion concentration. Blood pH-7.35 to 7.45.
Q10) Expand LCMS, HPLC,UPLC, TLC and GC?
Ans) LCMS- Liquid Chromatography
HPLC- High Performance Liquid Chromatography,
UPLC- Ultra High Performance Liquid Chomatography,
TLC- Thin Layer Chomatography,
GC- Gas Chromatography.
qc pharma interview questions for freshers
Q11) What is the HPLC principle?
Ans) It is a technique used for separating the mixture of components into individual components based on adsorption, partition, ion exchange and size exclusion principles. Stationary phase and mobile phase used in it. HPLC used for identification, quantification and purification of components form a mixture.
Q12) Explain HPLC instrumentation?
Ans) It involves solvent system, pump, Sample injector, HPLC columns, Detectors and Recorder. Firstly, solvent(mobile phase) is degassed for eliminating the bubbles. It is passed through the pump with a uniform pressure. The liquid sample is injected into the mobile phase flow stream. It passes through the stationary phase identified by the detectors and recorded.
Q13) In reverse phase HPLC, which type of stationary phase is used and give example?
Ans) Non polar stationary phase used
Ex: Silica gel C-18
Q14) What are the detectors used in HPLC?
Ans) UV detector, IR detector, Fluorescence detector, Mass spectroscopy, LC MS etc.
Q15) How to calculate Retention factor in paper chromatography? Ans) Rf = Distance travelled by solute/ Distance travelled by solvent.
Q16) Define molarity?
Ans) Number of moles of solute per litre solution. Denoted with “M”
Quality Assurance Pharma Interview Questions – Part 2
Q17) Define Molality?
Ans) Number of moles of solute per kilogram solvent. Denoted with “m”
Q18) Define Normality?
Ans) Number of Number of moles equivalent per litre solution.
Q19) Molecular weight of oxygen?
Difference between humidity and relative humidity?
Ans) Humidity – Measure of amount of water vapour present in the atmosphere.
Relative humidity- Water vapour amount exists in air expressed as a percentage of the amount needed for saturation at the same temperature.
Sample QA Interview Question: Why do we consider three consecutive runs/batches for process validation? Why not two or four? A. The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility. · First batch quality is accidental (co-incidental), · Second batch quality is regular (accidental), · Third batch quality is validation(conformation). In 2 batch we cannot assure the reproducibility of data,4 batches can be taken but the time and cost are involved.
Sample QA Interview Question: Explain about revalidation criteria of AHU system? A. AHU system shall be revalidated periodically as mentioned in the regulatory standards. AHU shall be revalidated in following cases also. · When basic design of AHU is changed, · When clean room volume is changed, · When new equipment is installed · When a construction is carried out, that calls for reconstruction of AHU system.
Sample QA Interview Question: What needs to be checked during AHU validation? A. During AHU validation, following tests shall be carried out · Filter efficiency test, · Air velocity & number of air changes, · Air flow pattern (visualization) · Differential pressure, temperature and RH · Static condition area qualification · Dynamic condition qualification · Non-viable count · Microbial monitoring · Area recovery and power failure study.
Sample QA Interview Question: Position of oblong tablets to be placed in hardness tester to determine the hardness? Lengthwise / widthwise? A. Position of oblong tablets should be length wise because the probability of breakage is more in this position.
Sample QA Interview Question: Explain in detail about qualification of pharmaceutical water system? A. Qualification of pharmaceutical water system involves three phases · Phase -1 · Phase -2 · Phase -3 Phase -1 A test period of 2-4 weeks should be spent for monitoring the system intensively. During this period the system should operate continuously without failure or performance deviation.Water cannot be used for pharmaceutical manufacturing in this phase.The following should be included in testing approach. · Under take chemical & microbiological testing in accordance with a defined plan. · Sample incoming feed water daily to verify its quality. · Sample each step of purification process daily. · Sample each point of use daily. · Develop appropriate operating ranges. · Demonstrate production and delivery of product water of required quantity and quality. · Use and refine the SOP’s for operation,maintenance,sanitization and trouble shooting. · Verify provisional alert and action levels. · Develop and refine test failure procedure.
Phase -2 A further test period of 2-4 weeks. Sampling scheme will be same as Phase – 1.Water can be used for manufacturing process in this phase. Approach should also · Demonstrate consistent operation within established ranges. · Demonstrate consistent production & delivery of water of required quality and quantity.
Phase – 3 Phase 3 runs for one year after satisfactory completion of phase-2.Water can be used for manufacturing process during this process.
Objectives & Features of Phase -3 · Demonstrate extensive reliable performance. · Ensure that seasonal variations are evaluated. · The sample locations, sampling frequencies and test should be reduced to the normal routine pattern based on established procedures proven during Phase -1 & phase – 2.
Sample QA Interview Question: What are the recommended environmental monitoring limits for microbial contamination?
Sample QA Interview Question: What is the difference between calibration and Validation? A. Calibration is a demonstration that, a particular Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
Where as Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
In calibration performance of an instrument or device is comparing against a reference standard. But in validation such reference standard is not using.
Calibration ensures that instrument or measuring devices producing accurate results. Whereas validation demonstrates that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).
Sample QA Interview Question: Briefly explain about ICH climatic zones for stability testing & long term storage conditions? A.ICH STABILITY ZONES Zone Type of Climate Zone I Temperate zone Zone II Mediterranean/subtropical zone Zone III Hot dry zone Zone IVa Hot humid/tropical zone Zone IVb ASEAN testing conditions hot/higher humidity
Long term Storage condition Climatic Zone Temperature Humidity Minimum Duration Zone I 21ºC ± 2ºC 45% rH ± 5% rH 12 Months Zone II 25ºC ± 2ºC 60% rH ± 5% rH 12 Months Zone III 30ºC ± 2ºC 35% rH ± 5% rH 12 Months Zone IV 30ºC ± 2ºC 65% rH ± 5% rH 12 Months Zone IVb 30ºC ± 2ºC 75% rH ± 5% rH 12 Months Refrigerated 5ºC ± 3ºC No Humidity 12 Months Frozen -15ºC ± 5ºC No Humidity 12 Months
Sample QA Interview Question: What is bracketing & matrixing in stability testing? A.Both Matrixing & Bracketing’s are reduced stability testing designs Bracketing The design of a stability schedule, such that only samples of extremes of certain design factors (ex:strength,package size) are tested at all time points as in full design.The designs assumes that the stability of any intermediate level is represented by the stability of extremes tested. Matrixing The design of a stability schedule, such that a selected subset of possible samples for all factor combinations is tested at a specified time point.At a subsequent time point another subset of samples for all factor combination is tested.The design assumes that the stability of each subset samples tested represents the stability of all samples at a given time point. There for a given time point other than initial & final ones not every batch on stability needs to be tested.
Sample QA Interview Question:What are the common variables in the manufacturing of tablets? A. · Particle size of the drug substance · Bulk density of drug substance/excipients · Powder load in granulator · Amount & concentration of binder · Mixer speed & mixing timings · Granulation moisture content · Milling conditions · Lubricant blending times · Tablet hardness · Coating solution spray rate
Sample QA Interview Question: Whether bracketing & validation concept can be applied in process validation? A.Both Matrixing & Bracketing’s can be applied in validation studies. Matrixing Different strength of same product Different size of same equipment Bracketting – Evaluating extremes Largest and smallest fill volumes Fastest and slowest operating speeds
1. What is an SOP ?
A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use.
2. What is 21 CFR part 11 ?
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records
What are user requirements ?
User Requirements Specification describes what users require from the System. User requirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.
4. What is a validation plan ?
Validation Plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:
Deliverables (Documents) to be generated during the validation process Resources/Departments/Personnel to participate in the validation project Time-Line for completing the validation project
5. What is an IQ document ?
Installation Qualifications are a collection of test cases used to verify the proper installation of a System. The requirement to properly install the system was defined in the Design Specification. Installation Qualifications must be performed before completing Operational Qualification or Performance Qualification.
6. What is an OQ Document ?
Operational Qualifications are a collection of test cases used to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements. Operational Qualifications are usually performed before the system is released for use.
7. What is a PQ Document ?
Performance Qualifications are a collection of test cases used to verify that a System performs as expected under simulated real-world conditions. The performance qualification tests requirements that were defined in the User Requirement Specification (or possibly the Functional Requirements). Due to the nature of performance qualifications, these tests are sometime conducted with power users as the system is being released.
8. What is a Validation Summary Report ?
Validation Summary Reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include:
A description of the validation project All test cases performed, including if those test cases passed without issue All deviations reported, including how those deviations were resolved
9. What is a Change Request ?
Change Control is a general term describing the process of managing how changes are introduced into a controlled System. In validation, this means how changes are made to the validated system. Change control is required to demonstrate to regulatory authorities that validated systems remain under control after system changes. Change Control systems are a favorite target of regulatory auditors because they vividly demonstrate an organization capacity to control its systems.
Sample QA Interview Question: Why water for pharmaceutical use is always kept in close loop in continuous circulation ? A. Water is a best medium for many microorganisms, microorganism can be a highly pathogenic which causes serious diseases(many diseases are water born), these pathogens infect after consumption of contaminated water, microorganisms tend to settle on a surface if water is allowed to stand in a stagnant position for few hours, these settled microorganism form a film over the surface of vessel and piping, such film formed by microorganisms is also called as biofilm, biofilms are very difficult of remove, once a biofilm is formed at a particular point then that point may form a biofilm again even after cleaning very easily as seed from this point is may not completely get removed effectively.
Biofilms then can become a source of microbial contaminations; therefore purified water after collection in a distribution system is always kept in a closed loop in a continuous circulation. A continuous circulation is also not enough at some points, therefore it is aided with high temperature range from 65 °C to 80°C, a minimum temperature of 65 °C is considered a self sanitizing, but better assurance is obtained with a temperature of 80°C .
Purified water collected should be stored in a stainless still vessel which must facilitate distribution to the point of use in a closed loop of continuous circulation, tank should be made of corrosion free material of construction, and must facilitate sanitization and easy cleaning.
Quality Assurance Pharma Interview Questions – Part 3
Sample QA Interview Question: Water for pharmaceutical use shall be free cations,anions and other impurities why ?
A.Water for pharmaceutical must be free from inorganic as well as organic impurities, minerals, and heavy metals. Some impurities like calcium, magnesium, ferrous are responsible for degradation of drug molecule, many cations like ferrous and calcium magnesium act as catalysts in degradation reaction of drug molecule, anions like chloride are highly active they participate in nucliophylic substitution reactions, where in they break a double bond between -C=C- in to a single bond as CL –CH-CH2- , which a reason why we observe that color dies tend to fed in presence of chlorine as most of the dies used are diazo compounds which has plenty of places for nucliophylic substitution reactions, which is also a reason why stability of drug is drastically affected in presence of cations and anions from mineral origin present in water.
Sample QA Interview Question: Water for pharmaceutical use shall be free heavy metals why ? A. Heavy metals like lead and arsenic are highly cumulative neurotoxic metals, heavy metals are not eliminated out of our body easily like other drugs and molecules but heavy metals bind with proteins and tend to get accumulated in fatty tissues, nerve tissue is most likely to get damaged by heavy metals, heavy metal causes nervous tissue damage there for water must be free from heavy metals.
Sample QA Interview Question: Brazil falls under which climatic zone ? A. Zone IVB (30 degree celsius and 75% relative humidity)
Sample QA Interview Question: Change in the size or shape of the original container requires any stability study? A. Change in the size or shape of the original container may not necessitate the initiation of new stability study.
Sample QA Interview Question: Forced degradation(stress testing) and accelerated stability testing are same? A. Forced degradation and stress testing are not same. Stress testing is likely to be carried out on a single batch of the drug substance. The testing should include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C) above that for accelerated testing), humidity (e.g., 75 percent relative humidity or greater) where appropriate, oxidation, and photolysis on the drug substance. The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension. Photo stability testing should be an integral part of stress testing.
Sample QA Interview Question: According to WHO guidelines what is the storage condition of climatic zone IVa and zone IVb? A. Zone IV a: 30°C and 65% RH (hot and humid countries) Zone IV b: 30°C and 75% RH (hot and very humid countries
Sample QA Interview Question: Countries comes under climatic zone IVb? A.Brazil,Cuba,China,Brunei,Cambodia,Indonesia,Malaysia,Myanmar,Philippines,Singapore,Thailand
Sample QA Interview Question: What is the purpose of stress testing in stability studies? A. Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.
Sample QA Interview Question: What is the formula for calculating number of air changes in an area? A. Number of air changes/hour in an area is
= Total Room Airflow In CFM x 60 Total Volume of room in cubic feet For calculating Total Room Airflow in CFM, first calculate air flow of individual filter. Formula is given below.
Air flow (in cfm) = Avg.air velocity in feet/Minute x Effective area of filter
Then find Total air flow. Formula is Total Air flow = Sum of air flow of individual filter.
Air flow Velocity can be measured with the help of Anemometer.
Sample QA Interview Question: What is dead leg? A. A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.
Sample QA Interview Question: What is the recommended bio burden limits of purified water & WFI? A. Purified water has a recommended bioburden limit of 100 CFU/mL, and water for injection (WFI) has a recommended bio burden limit of 10 CFU/100 mL. Sample QA Interview Question: Brief about ICH stabilty guidelines? A. Q1A- Stability testing of new drug substance & products Q1B- Photo stability testing of new drug substances & products Q1C-Stability testing of new dosage forms Q1D-Bracketing & Matrixing designs for testing of new drug substances and products Q1E-Evaluation of stability data Q1F-Stability data package for registration applications in climatic zone III & IV (Withdrawed)
Sample QA Interview Question: What is significant changes in stability testing? A. 1. A 5% change in assay for initial value.
2. Any degradation products exceeds its acceptance criterion.
3. Failure to meet acceptance criterion for appearance,physical artributes and functionality test.
4. Failure to meet acceptance criteria for dissolution for 12 units.
Sample QA Interview Question: If leak test fail during in process checks what needs to be done ? A. Immediately stop packing process and check for 1.Sealing temperature 2.Verify for any possible changes like foil width,knurling etc. 3.Check & quarantine the isolated quantity of packed goods from last passed inprocess. 4.Collect random samples & do retest. 5.Blisters from the leak test passed containers shall allow to go further and rest must be deblistered/defoiled accordingly.
Sample QA Interview Question: How many Tablets shall be taken for checking friability? A. For tablets with unit mass equal or less than 650 mg, take sample of whole tablets corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole tablets.
Sample QA Interview Question: What is the formula for calculating weight loss during friability test? A. %Weight loss = Initial Weight – Final Weight X 100 Initial Weight
Sample QA Interview Question: What is the pass or fail criteria for friability test? A. Generally the test is run for once.If any cracked,cleaved or broken tablets present in the tablet sample after tumbling,the tablets fails the test.If the results are doubtful,or weight loss is grater than the targeted value,the test should be repeated twice and the mean of the three tests determined.A mean weight loss from the three samples of not more than 1.0% is considered acceptable for most of the products.
Sample QA Interview Question: What is the standard number of rotations used for friability test? A. 100 rotations
Sample QA Interview Question: What is the fall height of the tablets in the friabilator during friability testing? A. 6 inches.Tablets falls from 6 inches eight in each turn within the apparatus.
Sample QA Interview Question: Why do we check hardness during inprocess checks? A. To determine need for the pressure adjustments on the tableting machine. Hardness can affect the disintegration time.If tablet is too hard, it may not disintegrate in the required period of time. And if tablet is too soft it will not withstand handling and subsequent processing such as coating,packing etc.
Sample QA Interview Question: What are the factors which influence tablet hardness? A. 1.compression force 2.Binder quantity(More binder more hardness) 3.Moisture content
Sample QA Interview Question: Which type of tablets are exempted from Disintegration testing? A. Chewable Tablets
Sample QA Interview Question: Which capsule is bigger in size – size ‘0’ or size ‘1’? A. ‘0’ size
Sample QA Interview Question: What is the recommended temperature for checking DT of a dispersible tablet? A. 25 ±10C (IP) & 15 – 250C (BP)
Sample QA Interview Question: What is mesh aperture of DT apparatus ? A. 1.8 -2.2mm (#10)
Sample QA Interview Question: What is the pass/fail criteria for disintegration test?
A. If one or two tablets/capsules fails to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is meet if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.
Sample QA Interview Question: What is the recommended storage conditions for empty hard gelatin capsules? A. 15 – 250C & 35 -55% RH
Sample QA Interview Question: Which method is employed for checking “Uniformity of dosage unit”? A. A.)Content uniformity B.) Weight Variation Weight variation is applicable for following dosage forms;Hard gelatin capsules,uncoated or film coated tablets,containing 25mg or more of a drug substance comprising 25% or more by weight of dosage unit.
Sample QA Interview Question: What is the recommended upward and downward movement frequency of a basket-rack assembly in a DT apparatus? A. 28 – 32 cycles per minute.
Sample QA Interview Question: When performing the ‘uniformity of weight’ of the dosage unit, how many tablet/capsule can deviate the established limit? A. Not more than two of the individual weights can deviates from the average weight by more than the percentage given in the pharmacopeia,and none can deviates more than twice that percentage. Weight Variation limits for Tablets
IP/BP Limit USP 80 mg or less 10% 130mg or less More than 80mg or Less than 250mg 7.5% 130mg to 324mg 250mg or more 5% More than 324mg
Weight Variation limits for Capsules IP Limit Less than 300mg 10% 300mg or More 7.5%
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A contract manufacturing organization (CMO) is a company that serves other companies on a contract basis to provide comprehensive services. In the pharmaceutical industry, the service ranges from drug development to drug manufacturing. Nowadays, it is also termed as contract development and manufacturing organization (CDMO), because of a comprehensive single-source provider from drug development through the commercial manufacturers. It is of help in terms of scalability and allows the major companies to focus on drug discovery and drug marketing instead. Global manufacturers are occupying a monster share of the contract manufacturing market with low-cost. Even the highest ranking service providers target a specific technology or dosage form for the promotion of end-to-end continuity. Therefore, specialization may be an effective hedge against the loss of market share. This reflects their efficiency for the outsourcing clients.
Pre-clinical and Phase I trial materials
Late-stage clinical trial materials
Formal stability, scale-up, registration batches and commercial production.
CMOs are contract manufacturers but aren’t limited to these services because of their development aspect. For the pharmaceutical market, the outsourcing services providers are used in the form of CMOs and CROs- contract research organizations. In response to the international nature of the pharmaceutical niche, CMOs are called for outsourced services.
Putting up a manufacturing unit is a big challenge for a layman not having the technical know-how and idea about the market. Carrying out a good technical and market survey would be beneficial. Moreover, depending upon one’s forte and the market demand the following are considered:
The ever-rising competition to be in demand as a constant cost-effective manufacturer
Regulatory compliance & Maintenance cost
Locations are selected based on Land cost, tax-free zones, accessibility to resources/transportation convenience.
Cost factor for faraway places or in government/private industrial zones.
You may choose formulation with a wide market to cover up the cost by having maximum utilization of installed pharmaceutical equipment. For people holding specialization and are sure about its actual application can create a market through the novel product/facility.
Regulatory checks are most important as its non-compliance seems untrustworthy.
Apply and comply with regulatory bodies country-wise to export products in the Indian Pharmaceutical Association website.
For Export registration, enquire the nearest Directorate General of Foreign Trade office.
Quality Control Executive Interview Questions & Answers
The fact is very common and it was observed during research that on average 80% of candidates suffer from Interview Fear / Phobia. At the same time those who are able to overcome the fear of exposure, are certain to be successful in any case. Once you clear the Job Requirement, you have to jot down the probable questions and their answers i.e. what all an interviewer can ask you thus making your own interview study material. While doing this sought help from your friends and seniors who are in similar position or industry. If you practise this exercise seriously, you will be able to find out mostly asked questions and you are ready to prompt 80% of the interview correctly. Quality Control Executive jobs are offered for bachelor’s degree and B. Pharmacy fresher, as well as experienced persons, are eligible to apply.
In the pharmaceutical industry, usually, one should qualify the first round of exam for attending the face to face interview. It also depends on which pharmaceutical company you are applying for. It is very important to understand the job profile and what kind of individual is needed for that position. For that clarity, you have to identify your strengths and weaknesses. It is advisable not to enter into any kind of argument with Interviewer. Accept that the interviewer(s) have more experience, listen carefully to them and never argue to justify your point during the interview. Besides knowledge, organizations prefer to choose people who are honest and also flexible in their approach. Rigidity in approach may cost you your position as the business environment is changing very fast these days.
Before the interview closes, it is better to ask for feedback from interviewer irrespective of how your interview went. With this, the impact becomes Organization members feel that candidate has a seeking attitude and is willing to accept feedback resulting in a favorable impression about the candidate.
Quality Control Executive Interview Questions & Answers
Below some are given to have an idea of what sort of questions one may prepare.
What is the difference between quality assurance and quality control?
Quality control is the process of identifying the defect and quality assurance is a process of improvement Quality control is reactive Action quality assurance is a protective action QC is a set of actions. Quality control takes CORRECTIVE ACTION during production,
Quality Assurance takes PREVENTIVE ACTION during development or after production (for completely prevention, if any defect arises)
What is the difference between Quality Assurance, Quality Control and Audit Function?
Quality assurance is a set of activities involved in the processes and Quality control is set of activities involved in product and audit function is nothing but the periodic inspection in the quality system.
What does 6 Sigma represent?
Six Sigma represents the six standard deviations from the mean toward the upper specification limit in a normally distributed sample where an average of 3.4 defects per million is reported to live.
Differentiate between product quality and process quality.
Product quality deals with the given specification of an individual product whereas the process quality deals with the process capability of the process that how much it can be effective to produce the quality products.
What is the maximum Acceptable Tolerance Limit for any product?
It is a TOLERANCE limit which is set by CONSUMER for acceptable any lot, parts, etc, generally within +/-5%
How do you track bug and report through Quality Control dept?
Tracking by sampling process, through
FIR (Final Inspection Report)
FOI (First off Approval Inspection Report)
Patrol Inspection Report
In Quality Assurance Plan & QC, what can be implemented to reduce rework in Acoustic Enclosure for manufacturing company?
Proper machine maintenance,
Consistent quality checks on the product,
Purchasing of quality raw materials,
Training and awareness of the operating procedure of the machine.
Quality Control Executive Interview Questions & Answers QA + QC PDF – Pharma Company Job Interview
When do we use a c-chart?
C chart is used when the item is too complex to analyse the product for confirming or not- confirming and subgroup size is same. It is used to monitor the number of defects per unit
What is meant by risk? How can you avoid the risks?
A risk is the possibility that an unfavourable event may occur. It may be predictable or unpredictable. A risk may have 3 components:
The event that could occur;
The probability that the event will occur;
The impact/consequences of the event that if it occurs.
One can avoid Risk by
Identifying the Risk, 2. Quantifying the risk i.e. by Risk identification & Risk Prioritization. 3. Risk Response Development 4.Risk Resolution & Risk Monitoring.
Here we have provided most commonly asked basic questions for the QCE pharmacy interview. There is no specific pattern/rule for asking the interview questions. As the level goes up the pattern also becomes changed for the particular cases where the candidate has worked in projects’ and sometimes they also may ask about the knowledge of the organization. It’s purely an interviewer choice. These interview related information of QC in pharmacy are based on some experienced interviewees suggestions. Hopefully, it would be of help!
Good Manufacturing Practice (GMP) is required for all the manufactured products to ensure their quality standards. GMP is designed to minimize the risks involved in any pharmaceutical production that are not eliminated through testing the final product. The compliance putting product quality first, being the best way to conduct business is widely-accepted. It covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff.
For each process, a detailed written procedure is maintained that could affect the quality of the finished product. There are systems providing documented proof that correct procedures are consistently followed every time a product is made.
Each step in the manufacturing process follows these basic principles:-
A clean, controlled and hygienic environment to prevent cross-contamination of the product from adulterants and allergens that may render it unsafe for use.
All the processes must be clearly defined controlled; critical processes are validated to ensure consistency and compliance with specifications. Any changes to the process must be evaluated with those affecting the quality of the drug are validated accordingly.
Trained Operators to carry out the document procedures as instructions and procedures need to be clear and unambiguous applying good documentation practices.
During manufacturing, manual or electronic records be kept demonstrating all the steps required by the defined procedures and instructions taken and the quantity and quality of the food or drug should be as expected. Deviations must be investigated and documented.
Keeping records of manufacturing including distribution process for the complete history of a batch to be traced in a comprehensible and accessible form.
A system must be in place for recalling any batch from sale or supply. Distribution of products shall minimize any risk to their quality.
A proper examination of complaints of marketed products with the investigation of the causes of quality defects. Appropriate measures must be taken with respect to the defective products and prevent recurrence.
Good manufacturing practice guidelines include manufacturing, testing, and quality assurance. Many countries have legislated that manufacturers follow GMP procedures guidelines in order to assure that a manufactured product is safe for human consumption or use. The procedure encompasses the following:
Here we present details on Contract manufacturing organization – Pharma CMO CRO for every one related to the pharma sector. Make clear of what it is and what it does. Lets go now in detail of Contract manufacturing organization.
Contract manufacturing organization
What is CMO?
Contract manufacturing organization
What is Pharma CMO?
Contract manufacturing organization related to Pharmaceutical products. It is known as contract development and manufacturing organization (CDMO).
How do drug manufacturers select the right contract research organization(CRO)?
I am not certain about the selection standards, but that which I believe is the standing of research business or the departmental heads in search business play significant part in receiving contract.You can add up in the comment section below if you have an idea of selection criteria of contract research organization(CRO)
What is the pricing structure for a contract manufacturing organization (CMO)?
The pricing structure is not much different than it is for conventional small molecule contract manufaturers. If speaking about API/Drug Substance, then there’s frequently a much longer company order interval and/or capital expenditure financing expectation given the size and timelines related to new capability. In terms of Drug Product/Sterile Filling (all vaccines and biologics are sterile and usually dispensed into vials, syringes, cartridges, bags, etc.), the pricing model again, is pretty similar. The sole reason biologics often command a higher price point is since there’s an increasing requirement there and contract makers presume the margins are greater, so customers would be happy to pay more. Now, regarding vaccines, particularly if using live virus vaccines, not many contract manufacturers will also provide their solutions. This is because a lot of the other customers would have a “restricted compound” clause that prohibits live brokers from being fabricated at exactly the exact same centre without prior written permission. There are a couple of vaccine contract manufacturers that serve this market, but the majority of large CMOs won’t handle vaccines.
How many Contract Manufacturing organizations are there in the USA?
Are contract manufacturing organizations specific/exclusive to the pharmaceutical industry alone or are they used in other industries?
IPhones are made by FoxConn, the largest contract manufacturer in the world.
TONS of electronics, aerospace, medical device manufacturers out there from big corporations to small local outfits.
How do I start a third party contract manufacturer in the pharmaceutical industry?
Third party mfg . Find out the requirements of the industry for which you want to manufacture the dosage form . Try to keep the budget and expenses in a limit to quote a competitive price . Find the governing bodies that provides licenses vendor lists and requirements related to get registered and certified. Refer USFDA GUIDELINES. google it Find a consultancy firm that can help you gain the standards and rectify the errors in the mfg unit . There is a good deal to be known and done . You’ll require a correct management group which will work on previously stated issues .
Top 7 Pharmaceutical Companies in Mumbai: India is the world’s third leading pharmaceutical manufacturing industry in terms of capacity and world’s 13th biggest pharmaceutical manufacturing industry by worth. There are bounteous pharmaceutical companies in India that manufacture all kinds of medicine for treating people. Here. I have compiled a big list of Top 10 Pharmaceutical Companies in Mumbai, India.
All the companies that I’ve mentioned in this article are the leading Pharmaceutical companies that play a vital role to enhance the healthy growth level all over the nation. All the companies are enlightening lives not only in Mumbai but also across the world from a decade. In this article, you can find out the best 7 pharmaceutical companies in Mumbai. Take a look!
Top 7 & Best Pharma Companies in Mumbai
GlaxoSmithKline Pharmaceuticals Limited
GlaxoSmithKline Pharmaceuticals Limited is one of the topmost Pharmaceutical companies that have developed from within and the declaration is not untrue as the company continually aims to grow on the several ways, but with the aid and strength of the employees that the company has recruited. This strong dedication and confidence brands the company truly as one of those personnel that make it tranquil to work proficiently for all the clients and the employees.
Cipla, does the name remind you anything? Well, Cipla is a widespread and most popular Pharma Company across the country This Company is among the biggest biotechnology and pharmaceutical multinational companies of India which was set up by Dr. K. A. Hamied in the year 1935.
Mostly, medicines for treatments of illnesses such as depression, arthritis, cardiovascular diseases, obesity and diabetes are developed by Cipla. Its products and services are categorised as APIs, Veterinary and formulations.
Corporate Headquarters: Mumbai, Maharashtra, India
Sector: Private Sector
Piramal Healthcare Limited
Piramal Healthcare Limited is a renowned and trustworthy name in the Pharmaceutical sector all over India. This company has a base set up in more than 30 countries throughout the world. It has been one of the most operative Pharma companies in Mumbai and now the company is powerful enough to make a great impression in the life of the people in all these 30 countries. It is a private sector company, which has an annual turnover of about 670 Million Dollar which is pretty much higher than any other Pharmaceutical company in India.
Corporate Headquarters: Mumbai, Maharashtra, India
Sector: Private Sector
Lupin is one of the most popular Pharmaceutical companies in Mumbai that is enduring its topmost position in this sector since ages manufacturing valuable medicines for the public. Lupin Limited is established by an associate professor at BITS-Pilani in Rajasthan namely Dr. Desh Bandhu Gupta in the year 1968. Now, it is one of the leading Pharmaceuticals in India.
It is one of the rapid developing companies which are quite popular in offering therapies in several departments that include oncology, cardiology, anti-infective, anti-asthma, gastroenterology, etc. Its products and services are categorised as generics, APIs, Biotechnology and much more.
Corporate Headquarters: Mumbai, Maharashtra, India
Sector: Private Sector
Ipca Laboratories Limited
Ipca has always been one of the well-reputed healthcare companies that have featured among the top 10 Pharmaceutical companies in Mumbai. They are pretty much well adapted to get the necessities of the people and have over the years technologically advanced some of the most operative medicines to combat against the wide-ranging health problems related to human health. This is one of the most vital companies in the field of medicine and drugs.
Corporate Headquarters: Mumbai, Maharashtra, India
Sector: Private Sector
Sun Pharmaceuticals, which is officially known as Sun Pharmaceutical Industries Limited was established in the year 1983 by Dilip Shanghvi. The company is headquartered in Mumbai, Maharashtra, which is the financial capital of India. Some of the specialised areas of Sun Pharmaceuticals are Active Pharmaceuticals Ingredients (APIs) and formulations. It aims at offering medicines to an extensive range of chronic and acute diseases.
Its healing sections are more than 3000 high quality molecules that include cardiology, orthopaedic, psychiatry, anti-infectives, neurology, gastroenterology, ophthalmology, nephrology, urology, respiratory, oncology, dermatology, gynaecology, dental and nutritionals. Its products and services are categorised as Formulations, Antiretroviral and Active Pharmaceutical Ingredients (APIs).
Corporate Headquarters: Mumbai, Maharashtra, India
Sector: Private Sector
Glenmark Pharmaceuticals is an Indian pharmaceutical company which was established in the year 1977 and headquartered in Mumbai, Maharashtra. This company specialises in few areas such as developing and marketing APIs and formulations. It also covers segments such as dermatology, gynaecology, ENT, paediatrics and internal medicine. Glenmark Pharmaceuticals is India’s largest pharmaceutical entity that offers various products and services categorised as formulations and APIs.
Corporate Headquarters: Mumbai, Maharashtra, India
Sector: Private Sector
These are the top 7 best Pharmaceutical companies in Mumbai Maharashtra that manufactures medicines in different segments thereby treats the illnesses of the public to a large extent.
Can we Invest on a pharma company? Pharmaceuticals Benefits in business: This article is all about pharmaceuticals as investment options and the benefits of investing in a pharma company rather than any other industries. You can choose between pharma and biotech depending on your interest exposure and investment options you have. You can have R&D or F&D, manufacturing , marketing, sales or QA , QC departments.
When you think about the benefits of investing in a pharma company you can hear these two things.
Pharmaceutical companies will always generate profits. I.e benefits
Probability of getting good returns after investing in industry
The first statement is absolutely FALSE. But the second statement is Highly suportable. So now you got what I’m going to talk about this.
Before we approach towards investment perspectives , here are some facts regarding Pharmaceutical industry.
Pharmaceutical Industry Facts
Pharmaceutical Industry size as per WHO – $300 BILLION. that’s why major pharmaceutical industries are called BIG PHARMA .
Over 5000 drugs are under development 70% of these are first line or firsorder which means they can be used for major diseases and disorders.
Indian pharmaceutical industry is growing at CAGR of 14% to 16% per annum.
India is a hub of generic manufacturers and more than 70% of drugs manufactured in India are sent abroad to countries like USA and Azerbaijan as well.
Indian pharmaceutical industry will suffer a decrease of 1% in terms of ROI (return on investment) but it shouldn’t bother first time investors.
Why you should consider pharmaceuticals as investment options?
There are few points you need to know regarding this which are really very crucial to know.
The share price is directly proportional to the industries approvals and development in pharma field . Eg. The share prices soar if industry wins approval for clinical trials/therapy/drug launch.
The ROI for a person who invested in pfizer (listed in New York stock exchange as PFE) in 2009 and withheld the shares to 2014 got a return of 116%. The scenario isn’t different in India. I don’t have exact figures for Indian company but as its market based you can check any companies figures. You will find them to be great.
Profits- chances of pharmaceutical industry going bankrupt etc is almost impossible. Once a pharmaceutical industry starts failing it is taken over by a giant or Big pharma company so your money may see ups and downs in such case but you will get good returns for sure.
The Net profit of pharmaceutical industries is around 30% to 35% YoY basis. An exception is pfizer that showed a 40% net profit for f.y 2012-13. The profit margins and profits is much more than oil, gas, banks and car makers as well.
Pharmaceutical company capital investment Facts
Do you know how much capital investment could be typically required for a small sized pharmaceutical company to start with? Let me make you clear about this also to give you a vague idea before you go to your actual research and statistics. Capital investment for pharmaceutical company depends on the size and resources you keep in the pharma company. This cost will include different licences and deposits for the company along with machinery, sale point , godown, transporting van and especially manpower .
Land in commercial or industry area to set up industry. Machines or equipments for various departments like QA QC MFG PACKAGING ETC. man power (skilled) with B.pharm or M.pharma . Marketing team .
Pharmaceutical industry involves various dependent and independent sections.
Dependent Sections of Pharma Company:
The industry depends on other industries as mentioned above to prepare its final dosage form.
Independent Sections of Pharma Company:
engineering and maintenance
The above mentioned sections work independently but in coordination to run a particular pharma industry. The number of sections may vary .
The reason We need to focus on the nature of work is that it will decide the man power , equipments , technology that you will need in your industry. Let’s consider that you want to open a compressed unit oral dosage form plant i.e. tablet manufacturing unit. This is for tablet unit the cost and will not fluctuate much in case of other dosage forms except parentrals and sera products .
From Indian scinario pharmaceutical industries are typically segmented into two
Manufacturing / + Marketing companies
Marketing only companies
a) Manufacturing / + Marketing companies
Manufacturing co. would need a bit more investment depending on the sections to be started, sections could be Tablets, Capsules, Syrups, Dry Syrups, Ointments, Softgel Capsules etc. You could choose a single section or two to start with gradually adding sections as per the demand of your products in the market.
b) Marketing only companies
If you think that you are good at marketing, you can get your products manufactured from companies already engaged in production. We are one of them. The marketing co. conceives the product and look after the distribution and sales, the production hassles are taken care by the manufacturer, this is termed as Contract Manufacturing. Marketing co. could be started with a small amount starting from few lakh of rupees. Again it all depends how many products you wish to start with.
All of these things will cost you around 2cr INR approximately if you are planning to establish in a region like pune MIDC (out skirts) on a small scale .The cost may be brought down significantly by using varying quality of lab equipment and technology but for a long lasting and fine result generating professional units this is the price approximately. A HPLC unit will cost more than 10lakh INR itself.
Source: Quora-Suraj Thakur & Akshi Talwar
The fact is that, first two years will be of real struggle as failure is what you will face but it shall be followed by days of glory.I hope it gives you a reason why you should consider investing in pharmaceutical industry.So, do proper research on your business and also you can take ideas from some experts. Some business companies like Angel Investment Network has achieved higher success with good startups. They are also helping those startup companies find funding and guidance. It can be beneficial for you also to take some ideas about it. Good Luck.