Good Manufacturing Practices
Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biological including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.
GMP guidance
The first WHO draft text on GMP was adopted in 1968. In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the quality of pharmaceutical products moving in the global market, it accepted the WHO GMP as an integral part of the Scheme. A supplementary annex on biological medicinal products was adopted by the Expert Committee on Biological Standardization (ECBS) in 1991 and establishes the general approach to the quality control of biological medicines that include products such as vaccines, blood and blood products, antigens, cell and tissue therapies, biopharmaceutical products, and others.
More than 100 countries have incorporated the WHO GMP provisions into their national medicines laws, and many more countries have adopted its provisions and approach in defining their own national GMP requirements. The WHO GMP continues to be used as a basis for the WHO Certification Scheme and prequalification of vaccines for procurement by UN agencies.
In summary, the main requirements of the GMP Code of Practice are as follows:
- The definition of all production processes is clearly, systematically, operationally and revised, in such a way that the capacity and capacity for producing the product are ascertained in quality and in accordance with the predicted specification.
- Validation of critical processes of production processes and major changes in each process.
- Provide the following facilities and equipment:
• Suitable, skilled and trained personnel
• Building and sufficient space
• Appropriate equipment and services
• Proper materials, containers and labels
• Proper storage and transportation
• Approved directives and guidelines
- Developing directories and instructions, in particular for the use of tools and facilities, clearly, operationally, in plain and unambiguous language.
- Train operators so that they can prepare for the correct process.
- Provide manual / machine records during production operations, indicating that all steps and procedures are in accordance with defined guidelines and guidelines, and the production of the product with quantitative and qualitative characteristics is predicted.
- Any risk aversion should be recorded and reviewed.
- Maintaining records of various stages of production, including full records and traceable distribution, in a comprehensive and accessible distribution of products with minimal occurrence of any form of their quality.
- The existence of an accessible system to restore the major and minor sold goods
- The existence of a system for investigating complaints about sold products, investigating the causes of qualitative defects, carrying out corrective actions and preventing their repetition
Briefly, parts of a production unit under GMP rules are:
- Sales Production
- Building
- equipment and devices
- Personnel
- cleaning
- Raw materials testing
- production control
- Qualitative control section
- Packing materials testing
- Final product tests
- Documentation
- samples
- Handling complaints
- Product recall