GMP Certification

Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Good manufacturing practices, along with good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, in addition to other countries.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

All guidelines follow a few basic principles:

• Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
• 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.

Benefits of the GMP

• Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers
• Increases senior management confidence in the preparedness of manufacturing facilities for inspection
• Decreases the time and cost for companies selecting third-party testing and product certification if using GMP registered contract manufacturer; which is a national program that is designed to provide a system of processes, procedures, and documentation to ensure that the product produced has the identity, strength, composition, quality, and purity that it is represented to possess
• Manufacturers of dietary supplements that comply with GMP requirements receive certificates and are listed on the NSF website
• Available to all manufacturers of dietary supplements.