- 21 CFR Part 210, titled Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, is a foundational component of the U.S. Food and Drug Administration’s (FDA) regulatory framework for ensuring the quality and safety of pharmaceutical products. This regulation establishes the general provisions and scope for Current Good Manufacturing Practice (CGMP) requirements that apply to both human and veterinary drugs. It serves as the legal basis for how drugs must be manufactured in the United States to ensure that they are safe, effective, and meet quality standards.
- Part 210 provides a structural overview and legal definitions that are essential for the interpretation and application of the more detailed requirements set out in 21 CFR Part 211 (which covers CGMP for finished pharmaceuticals). It begins by defining the applicability of CGMP regulations to all drug products manufactured, processed, packed, or held for commercial distribution. It emphasizes that any failure to comply with these requirements results in the drug being considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even if there is no visible defect in the product.
- This part of the regulation introduces several critical definitions, including “drug product,” “active pharmaceutical ingredient,” “batch,” “lot,” “control procedures,” and “quality control unit.” These definitions ensure clarity and consistency across the regulatory landscape. Importantly, Part 210 also defines what constitutes a “manufacturer” and specifies that contract manufacturers, laboratories, and packagers are also subject to CGMP regulations, reinforcing shared responsibility for product quality and compliance.
- Another key aspect of 21 CFR Part 210 is its mandate for manufacturers to comply with both Part 210 and Part 211, or with other applicable GMP parts (such as Parts 225 or 226 for medicated feeds). Part 210 also outlines exemptions and special cases. For example, some investigational drug products may be exempt from certain CGMP requirements during early-phase clinical trials, although they still must be produced under appropriate quality controls.
- Part 210 provides the framework for FDA inspections and enforcement actions. It empowers the FDA to conduct routine and for-cause inspections of drug manufacturing facilities and assess compliance with CGMP. If a manufacturer is found to be in violation, consequences can include FDA warning letters, import alerts, product recalls, injunctions, or even criminal prosecution in severe cases.
- In summary, 21 CFR Part 210 serves as the legal and conceptual backbone of U.S. CGMP regulations for pharmaceuticals. It defines the scope of the rules, establishes key terms, and reinforces the FDA’s authority to enforce manufacturing standards. While it does not contain the detailed operational requirements found in Part 211, it is essential for understanding the broader regulatory context and legal obligations of drug manufacturers operating within or supplying to the U.S. market.
