Interview Preparation for Regulatory Affairs Role: In the Pharmaceutical industry, Regulatory Affairs is a profession, acting as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products prior to their marketing for respective countries. The goals of Regulatory Affairs Professionals are Protection of human health, Ensuring safety, efficacy and quality of drugs with appropriateness and accuracy of product information

Depending on the type of regulatory affairs role you are going for, you are to answer different questions. Therefore the first recommendation for the preparation is to take a look at the job description and try to practice the probable questions. Also, match your CV against the job profile such as the criteria of where and where have you demonstrated the skills, characteristics and experience the interviewer is looking for…

Let’s find out the Roles of Regulatory Affairs professionals

1. Act as a liaison with regulatory agencies. For translating regulatory requirements into practical workable plans they provide expertise and regulatory intelligence
2. Organize and prepare scientifically valid NDA, ANDA, INDA, MAA, DMF submissions

• Adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws

1. Adviser to the companies on regulatory aspects and climate that would affect their proposed activities

There are various other roles which Regulatory Affairs professionals play so you must be well aware of what preparation is apt to you.

Generally, the main questions during an interview include the following:

• The interview will go around regulatory authorities or agencies if you have dealt with any.
• Electronic submissions have evolved as a big part of regulatory affairs work nowadays. You can expect questions on it and your experience to date.
• If the regulatory affairs job offers to work for a UK affiliate, be prepared to be asked about your experience of dealing with MRHA.
• Often, in the interview of regulatory affairs job, you will be given the companies that tend to operate on a global level, who are doing global submissions. Since experience matters, in most cases, you can prepare yourself to answer questions about your experience of team working on a global level. It’s better to collect data about the times when you have worked as part of a team on a global level, and the impact you made.

Interview Preparation for Regulatory Affairs Role IPR

Here are some Interview questions and answers:

1. What is an Investigational New Drug (IND) application?

Ans- It is an application which is filled with FDA to get approval for legally testing an experimental drug on human subjects in the USA.

2. What is CTD?

Ans-The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.

3. 3. What are the modules in CTD?

Ans- The Common Technical Document is divided into five modules:

Module 1. Administrative information and prescribing information

Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)

Module 3. Quality

Module 4. Nonclinical Study Reports (toxicology studies)

Module 5. Clinical Study Reports (clinical studies)

4. 4. What are the chemical classification codes for NDA?

Ans-

5. What is a New Drug Application?

Ans- The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA

In simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA”

6. What is an Abbreviated New Drug Application (ANDA)?

Ans- It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.

In simple words, “It is an application for the approval of Generic Drugs “

7. What is a Generic Drug Product?

Ans- A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

8. What is a DMF?

Ans- A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Important facts regarding DMFs

• It is submitted to FDA to provide confidential information
• Its submission is not required by law or regulations
• It is neither approved nor disapproved
• It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these
• It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420
• It is not required when applicant references its own information

9. What are the types of DMF’s?

Ans-

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information (FDA discourages its use)

10. What is a 505 (b)(2) application ?

Ans- 505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference.

11. What kind of application can be submitted as a 505(b)(2) application?

Ans-

• New chemical entity (NCE)/new molecular entity (NME)

• Changes to previously approved drugs

12. What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ?

Ans-

• Change in dosage form.

• Change in strength

• Change in route of administration

• Substitution of an active ingredient in a formulation product

• Change in formulation

• Change in dosing regimen

• Change in active ingredient

•  New combination Product

• New indication

• Change from prescription indication to OTC indication

• Naturally derived or recombinant active ingredient
• Bioinequivalence

13. What is Hatch-Waxman act?

Ans-It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs. Paragraph IV of the act, allows 180 day exclusivity to companies that are the “first-to-file” an ANDA against holders of patents for branded counterparts.

In simple words “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics”

14. What are the patent certifications under Hatch-Waxman act?

Ans-As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following:

(I) that the required patent information relating to such patent has not been filed (Para I certification);

(II) that such patent has expired (Para II certification);

(III) that the patent will expire on a particular date (Para III certification); or

(IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification).

A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.

15. What is meant by 180 day exclusivity?

Ans-The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit.

180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium).

Interview Preparation for Regulatory Affairs Role IPR Question and Answers

16. What are the procedures for Approval of Drug in EU?

Centralised Procedure (CP)

Decentralised Procedure (DCP)

Mutual Recognition Procedure (MRP)

National Procedure (NP)

17. What is the Full form of abbreviation, CEP?

Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs

It is also informally referred to as Certificate of Suitability (COS)

18. What is a CEP?

It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.

19. What is ICH?

Ans-International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

20. What is a Marketing Authorization Application?

Ans- It is an application filed with the relevant authority in the Europe (typically, the UK’s MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine.

As per UK’s MHRA-

Applications for new active substances are described as ‘full applications’.

Applications for medicines containing existing active substances are described as ‘abbreviated’ or ‘abridged applications’.

At one time or another most of us will have to go through a formal interview with a company that has a job opportunity we are interested in. Pharma Interview Questions And Answers For Fresher’s Pdf Free Download – QA QC MR Pharmacist Interview. The interview is probably the most difficult part for most people because there is always apprehension about what questions will be asked and how they should respond.

The way in which applicants answer job interview questions will greatly determine if they get the job or not. Applicants should be confident in their responses and project professionalism throughout the interview, and answer job interview questions truthfully and respectfully, not to say that some personality should not be projected, but should be kept inline with that of the interviewer.

Pharmaceutical Interview Questions And Answers in pdf

What Is Warfarin And What Are Some Of The Drugs It Interacts And Should Be Avoided?

Answer :

Warfarin is a drug used as anti-coagulant, and it is used in patient who is at high risk of heart attack due to blood clot.

Some of the drugs with which it interacts and should be avoided in combination with

Aspirin
Clopidogrel
Danaproid
Dipyridamole
LMWHs
NSAIDs
Ticlopidine
Unfractionated heparin

What Is Nabp?

Answer :

NABP is the Electronic Licensure Transfer Program allows licensed pharmacists to transfer their existing pharmacist license easily from one state to another.

Explain How Pharmacist Can Help The Patient With Asthma?

Pharmacist can help the patient with Asthma by educating them and give information on it

Trigger management
Role of controller medications
Role of Rescue medications
Early detection of disease

Interview questions for quality assurance in pharmaceutical industry

Tell me about Validation

Prospective validation: Conducted prior to process implementation to assuring that process is performs as intended on the basis of pre-planned plans.
Concurrent validation: Conducted during the product routine production.
Retrospective validation: Conducted on some products , those products which are already on commercial market. The intention is to establish the long term compliance of that product.
Re-validation: This is nothing but repetition of validation. Conducted to assuring that the changes/modifications done in equipment/process in according to the change control procedures. Those changes are not effecting the equipment/process and their produced products adversely.

Pharma Interview Questions And Answers For Fresher’s Pdf Free Download – QA QC MR Pharmacist Interview

Medical representative interview questions and answers for freshers pdf free download

How can you become a successful pharmaceutical representative?
Pharmaceutical sales is a high turnover business and to get its foot into it requires
• Positive Approach
• Good Network and Focussing on Sales call
• Good communication skills
• Good product knowledge
• Understanding market value of your product
• Good research on competitors and their sales target
•
• Explain why pharma sales is different than other sales?
• Pharmaceutical sales is an indirect sales role
• Pharmaceutical sales have no order to close or contract to sign
• It serves for an expert physician promoting product through education and awareness

Quality control interview questions and answers pdf

Q/A
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

PHARMACEUTICAL QUALITY ASSURANCE INTERVIEW QUESTIONS & ANSWERS

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.

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.

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:
o A description of the validation project
o All test cases performed, including if those test cases passed without issue
o All deviations reported, including how those deviations were resolved

Pharmaceutical Industrial Interview Questions and Answer — QC & QA

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)

QA Pharma interview questions and answers for freshers pdf free download

How are filters be used?
Filters are used to sort the test results. A tester can easily find all pass or fail results using a filter.
What is the Test Lab?
The Quality Centre Test Lab where tests are executed. Tests from the test plan can be added to test trees that run in various test cycles.
How can the defect management cycle be tailored in Quality Center?
Once all of the defect attributes that will be tracked (i.e. version, details, etc.) are determined, use the “Modify Options” feature of Quality Center to customize.

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.

TOP QC INTERVIEW QUESTIONS AND ANSWERS PDF

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.

Pharmacist Interview Questions And Answers For Fresher’s Pdf Free Download 

 What Is The Responsibility Of A Pharmacist?

The responsibility of a pharmacist is to

Manage a drug store
Advising patients and physicians
Verifying accuracy of prescription
Reviewing possible side effects
Assigning correct dosage
Recommending most appropriate non-prescription drug
Give information to the patient about drug interaction
Question 2. What Are The Three Qualities A Professional Pharmacist Should Have?

Answer :

Drug Management
Customer Management
Staff Management
Question 3. What Are The Record Keeping Procedures That A Pharmacist Have To Do?

Answer :

The record keeping procedures that a pharmacist have to do

Storing pharmacy files
Patient records
Inventories and update system files
Registries of poisons and controlled drugs
Question 4. What Are The Side Effects Of Methadone?

Answer :

The side effects of methadone are:

Feeling anxious, nervous or restless
Insomnia ( Sleeping disorder )
Feeling drowsy and weak
Nausea, vomiting, diarrhoea, constipation, loss of appetite, dry mouth
Impotence
Question 5. Classify The Controlled Drug? What Is The Storage Procedure For Controlled Drug?

Answer :

Controlled drug is classified into five, Schedule type 1, Schedule type 2, Schedule type 3, Schedule type 4 and Schedule 5.

For CD drug, it should be stored into a closed cabinet made up of metal and with a lock on it. Moreover, only authorized person should have an access to it and only he can administer the CD drug to the patient. For home visit doctor should carry in a lockable bag.Phatmacist.

 Is Pharmacist Allowed To Give A Copy Of Prescription?

Yes, pharmacist is allowed to give a copy of prescription but they can only use a copy of prescription for an informational purpose only. A pharmacist cannot dispense a drug from a copy of a prescription. They can contact your doctor to provide you with a new prescription in case you lost your prescription based on the information on the Copy of prescription.

Final Words

Whether it is your first job after graduation or a well-considered career move, you always need to be well prepared for the interview. Ensure that your resume is well written. To stand out from the crowd, a professionally written resume is a wise investment. A well-written resume and cover letter will ensure that you are called for a job interview. The process of interviews intimidates many, but you should look at it as a discussion to determine if you are suitable for the job and if this company is right for you. Keep in mind that being well prepared for an interview is as important as the interview itself.The best advice you can get is to remain true to yourself, relax and be calm throughout the entire interviewing process. Our pharmawiki site have great suggestions on the subject of interviewing and how to come out on top!  

Hope you liked this article Pharma Interview Questions And Answers For Fresher’s Pdf Free Download – QA QC MR Pharmacist Interview.Good Luck!!