GMP Good Manufacturing Practices
Introduction
Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP) are two tools for a meat processing facility that help for the production of high quality and safe meat products. The programs established for GMP's and SOP's will provide the basis for other programs the help to assure the level of product quality such as standards for ISO 9000 and for product safety in the Hazard Analysis and Critical Control Point (HACCP) system. Many companies like to view these systems as a pyramid (Figure 1.) with the GMP's and SOP's supporting the more advanced program of HACCP and all three programs being important for the ISO 9000 system.
Figure 1. GMP's and SOP's form the foundation for the hazard analysis and critical control point system (HACCP) and ISO 9000.
Although there are a number of them, all guidelines follow a few basic principles:
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
- Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
- Operators are trained to carry out and document procedures.
- Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
- The distribution of the drugs minimizes any risk to their quality.
- A system is available for recalling any batch of drug from sale or supply.
- Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process
Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
Can manufacturers afford to implement GMP?
Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.