Good Manufacturing Practices (GMPs) are a set of guidelines that provide a system of processes, procedures and documentation to assure a product has the identity, strength, composition, quality and purity that appear on its label.GMP covers all aspects of production, from the initial materials, premises and equipment to training, personal hygiene and environment. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There are systems in place to provide documented proof that all correct procedures are consistently followed within each step of the manufacturing process every single time a product is made.GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous.
A basic outline of GMP guidelines:
- Manufacturing facilities must maintain a clean and hygienic manufacturing area, including all labs and storage.
- Manufacturing facility design, operating principles and environmental conditions must be controlled to prevent cross-contamination of drug products, and to prevent cross-contamination from labelled or un-labelled material or products.
- Manufacturing processes must be clearly defined, validated and controlled to ensure consistency and compliance with specifications. Any changes to the process are evaluated from a patient safety and product quality perspective and any approved change that may affect the quality of the drug are qualified or validated as necessary.
- Instructions and procedures must be written in clear and unambiguous language.
- Operators should be trained to carry out the production and control of products according to documented and approved procedures.
- Records should be made during manufacture and quality control, demonstrating that all the necessary steps required by the defined procedures and instructions were executed as defined and that the specified quality attributes of the products have been met. Deviations are investigated and documented.
- The process should remain in a state of control throughout the product life cycle and improvements completed as needed.
- Records of manufacture (including distribution) are retained in a comprehensible and accessible format that can trace the complete history of a batch.