Good Manufacturing Practices (GMPs) are manufacturing and administrative procedures and practices aimed to ensure that medicinal products, medical devices, food supplements and cosmetic products manufactured meet the required requirements, specifications and customer expectations in order to supply a safe and effective product to consumers…
GMP regulations include a variety of products such as human pharmaceutical products and veterinary products, biologically derived products, medical devices, packaging or food products. The principle of the regulations is that quality cannot be tested in the final product and /or in a specific batch or test, but rather be integrated in the entire manufacturing process, from raw material receiving and testing, until final product storage before distribution.
The GMP principles implementation and as part of that, receiving and in-process testing, in conjunction with other controls, monitoring and testing will enable to minimize the risks during production that cannot be eliminated by testing of final product only.
In the United States, the Food and Drug Administration (FDA) has issued these regulations as the minimum requirement for drug substances, drug products, medical devices, supplements and cosmetic products. Quality Assurance, production managers and senior management are responsible for ensuring that all procedures, practices, policies and SOPs are complying with cGMP guidelines.
Ten basic principles of GMP:
- Proper design and construction of the facility, utilities and equipment
- Proper Maintenance of utilities and equipment
- Validation of facility, utilities, equipment, manufacturing processes, cleaning, testing methods and software
- Write standard operating procedures and follow them
- Document processes
- Employees certification, development and training
- Contamination protection and prevention
- Employees health/hygiene
- Quality built into the whole product lifecycle
- Audits and inspections