21 CFR Parts 210 and 211 are U.S. Food and Drug Administration (FDA) regulations outlining Current Good Manufacturing Practice (CGMP) for manufacturing, processing, packing, or holding of drugs. While both relate to CGMP, they cover different aspects of the process.
21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
Part 210 provides a general overview and foundational requirements for CGMP. It establishes the minimum requirements for the methods to be used and the facilities or controls to be used for the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. Think of it as setting the stage for all subsequent, more specific rules.
- Scope: Defines the applicability of CGMP regulations.
- Definitions: Clarifies the meaning of terms used throughout the regulations.
- General Provisions: Lays out overarching principles for drug manufacturing.
21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
Part 211 builds upon the foundation laid by Part 210 and provides detailed and specific CGMP requirements for finished pharmaceutical products. This part delves into the specifics of how to implement CGMP throughout the manufacturing process.
- Organization and Personnel: Requirements for personnel qualifications, training, and responsibilities.
- Buildings and Facilities: Standards for facility design, cleanliness, and maintenance.
- Equipment: Requirements for equipment design, maintenance, and calibration.
- Control of Components and Drug Product Containers and Closures: Procedures for handling and testing raw materials and packaging materials.
- Production and Process Controls: Detailed requirements for manufacturing processes, including written procedures, process validation, and in-process testing.
- Packaging and Labeling Control: Procedures to ensure accurate packaging and labeling of drug products.
- Holding and Distribution: Requirements for storing and distributing drug products to maintain their quality and integrity.
- Laboratory Controls: Procedures for testing raw materials, in-process materials, and finished products.
- Records and Reports: Requirements for maintaining accurate and complete records of all manufacturing activities.
- Returned and Salvaged Drug Products: Procedures for handling returned or salvaged drug products.
Key Differences Summarized
Here's a table summarizing the key distinctions:
| Feature | 21 CFR Part 210 | 21 CFR Part 211 |
|---|---|---|
| Scope | General CGMP principles for all drugs. | Specific CGMP requirements for finished pharmaceuticals. |
| Focus | Foundational requirements and definitions. | Detailed instructions for implementing CGMP in practice. |
| Specificity | Broad and general. | Highly detailed and specific. |
| Content | Overarching principles, definitions. | Organization, facilities, equipment, controls, etc. |
In short, Part 210 sets the general guidelines, and Part 211 provides the specific instructions for how to meet those guidelines in the production of finished drug products. Both are crucial for ensuring the quality, safety, and efficacy of pharmaceuticals in the United States.
