GMP assures the quality of manufacturing process of medical related products, food and related industry. Poor quality products are considered as a waste of time because they are very much hazardous for health & even sometimes lead to death of a person also. GMP is the part of quality assurance which makes sure the quality of product and reduces the risk of poor quality which may not lead to the bad health of customers. GMP confirms the guidelines of the agencies which are the licensing body of manufacturers of medical and food related products. It also makes sure that high quality products do not pose any risk to the consumer or public. In some of the countries good manufacturing practices, laboratory practices and clinical practices are overseen by the regulatory agencies. Good manufacturing practice guidelines guides for the good quality, and testing of products so that it does not have the poor affect to human consumption or the consumers.
All guidelines follow a few basic principles:
- The distribution of the products minimizes any risk to their quality.
- Operators are trained to carry out and document procedures.
- Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
- Controlled environmental conditions in order to prevent cross contamination of drug/food product from other extraneous particulate matter which may render the product unsafe for human consumption.
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- A system is available for recalling any batch from sale or supply.
- Hygiene of manufacturing facility must maintain a clean and hygienic manufacturing area.
- Complaints about marketed product are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the product are validated as necessary.
- 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 product was as expected.
- Records of manufacturing & distribution with batch code needs to be maintained.
Benefits of GMP:
- Customer satisfaction.
- Ensures health and safety of a customer.
- Improves the reputation of organization or a company.
- Ensures effective and efficient product quality.
- Reduces the risk of poor quality.