Why is GMP so important - Answers from the FDA

Why is GMP so important? This question is answered by the FDA in an article on facts about cGMPs. The FDA explains the following in a compact form in 6 paragraphs on two pages:

  • What are cGMPs?
  • Why are cGMPs so important?
  • How does FDA determine if a company is complying with cGMP regulations?
  • If a manufacturer is not following cGMPs, are drug products safe for use?
  • What can FDA do to protect the public when there are cGMP violations by a manufacturer of drug products?
  • How would a drug products company learn about cGMPs and about FDA's expectations on complying with them?

The FDA also explains the meaning of the "c" in cGMPs in the first paragraph "What are cGMPs?" It allows flexibility in the interpretation of the GMP rules and requires industry to adapt its procedures to the state-of-the-art. It is mentioned explicitly that cGMPs are minimum requirements and that many companies are therefore implementing modern quality systems and risk management approaches to complement the cGMPs. Otherwise, the usual (cGMP) measures in a pharmaceutical company (use of appropriate raw materials, robust operating procedures) and the aim of these measures (for example to ensure the drug quality, to prevent contamination etc.) are explained in a very compact form.

In paragraph 2 on the importance of GMPs the FDA points out that in most instances testing concerning the quality of drug products is done on a small sample of a batch since the tests destroy the samples and that therefore it is not possible to test the complete batch. In this regard, the FDA points out that testing of the final product alone is not adequate to ensure quality and that the quality must be built into the design (and carrying out) of every step of the manufacturing process. Again, there are listed examples (properly maintained and calibrated equipment, qualified employees etc.).

Paragraph 3 (How does FDA determine if a company is complying with cGMP regulations?) shortly addresses FDA's way of inspecting. Furthermore, it is mentioned that the FDA also analyses public reports or reports from the industry on potentially defective drug products. The statement that most inspected companies are fully compliant is interesting.  

Paragraph 4 explains that if a company is not complying with cGMP regulations, any drug it makes is considered "adulterated" under the law.  But this does not mean that there is necessarily something wrong with the drug because there are different forms of violations of GMP. In this context FDA advises consumers not to interrupt their drug therapy and not to use another product. Consumers should seek advice from their health care professionals beforehand.

In paragraph 5 the FDA explains the complete range of possibilities it can choose among in the case of cGMP violations. This starts with influencing the manufacturer to recall the product and ends with legal proceedings at the request of the FDA that can even lead to imprisonment in the worst case.

The last paragraph refers to the Federal Register and FDA's website as source of information on cGMPs and FDA expectations. The FDA also refers to its presentations at international meetings. 

Conclusion: The article is perfectly suitable for getting short and concise information on the significance of cGMP for the FDA and on possible consequences in the case of non-compliance with the cGMP rules. Insofar it also is suitable for the first training of employees in companies producing drugs that are exported to the United States and are therefore under FDA supervision.

Please also see the complete article entitled "Facts About Current Good Manufacturing Practices (cGMPs)".

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