GMP requirements for the Pharmaceutical Industry
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:
- Quality Systems
- Facilities and Equipment Systems
- Materials Systems
- Production Systems
- Packaging and Labelling Systems
- Laboratory Control Systems