The Ten Commandments (Principles) of GMP (Good Manufacturing Practice)
GMP is basically a strict Quality Control System used in the Food and Beverage as well as Pharma industries to ensure the quality of the product. It is one of the highest standards of quality in Industry so as the health of people the final consumers of the products is protected. In the USA, GMP follows the principles laid out by the U.S. Food and Drug Administration (FDA), under Title 21 CFR.. In the EU, the EU Pharmacopeia is followed. In Japan, the Japanese Pharmacopeia. For a drug to enter the Eu market, it must follow the Eudralex rules and regulations. Here is a link to the Eudralex GMP Guidelines and Rules.
In the USA, the FDA and the USP overlap as far as the chemistry, strength, etc. of drugs are concerned. Once the product’s usage in the marketplace is established by the FDA (through clinical trials), the USP primarily takes over and follows that product until it is no longer produced.
Below are the Ten Commandments of GMP:
1. Write Standard Operating Procedures for processes and Design Specifications for equipment and premises.
2. Follow the SOP’s and Specs.
3. Prove/Validate the SOP’s and specs – make sure they work
4. Integrate Quality in the design phase, make it a part of the specs
5. Maintain everything and keep records
6. Use only competent, qualified and trained personnel
7. Cleanliness/good personal hygiene should become part of the MO to eliminate risk of pollution of the product. For this reason, Cleaning Validation is performed and SOP’s are followed.
8. Inegrate Quality in operations, manufactoring, logistics and distribution.
9. Document everything for traceability.
10. Perform Planned Audits by Certified Auditors to ensure continuous improvement.
GMP guidelines follow a few basic common sense principles:
1. Manufacturing facilities must maintain a clean and hygienic manufacturing area.
2. Controlled environmental conditions in order to prevent cross contamination of drug products from adulterants that may render the product unsafe for human consumption.
3. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
4. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that affect the quality of the drug are validated as necessary.
5. Cross contamination with unlabelled major allergens is prevented.
6. Records are kept, manually or by computers, during manufacturing 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.
7. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
8. The distribution of drugs minimizes any risk to their quality.
9. A system is available for recalling any batch from sale or supply.
10. Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
Brought to you by Rami E. Kremesti M.Sc., CWEM, CEnv, CSci
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