Good Manufacturing Practices (GMP) Requirements
GMP Overview
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
Drug cGMP Requirements
The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
GMP Inspections and Enforcement
FDA inspects pharmaceutical manufacturing facilities worldwide using scientifically and cGMP- trained individuals whose job it is to evaluate whether the company is following the cGMP regulations. FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the cGMP regulations.
If the failure to meet cGMPs results in the distribution of a defective drug, the company may subsequently recall that product. While FDA cannot force a company to recall a drug, companies will usually recall voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn the public and could seize the drugs that are on the market. FDA can also bring a seizure or injunction case in court to address cGMP violations. Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct cGMP violations.
Helpful Resources
Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. The following are some resources that may be helpful in understanding how cGMPs establish the foundation for drug product quality:
- FDA regulation- Other education material about cGMP:
- 21CFR210--Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
- 21CFR211—Current Good Manufacturing Practice for Finished Pharmaceuticals
- FDA Guidance for Industry
- Facts About Current Good Manufacturing Practices (cGMPs)
- Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs
- Current Good Manufacturing Practices (cGMPs)/Compliance
- GMP requirements for Active Pharmaceutical Ingredients (APIs) –– also known as ICH Q7
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