21 CFR 211.165
Table of Contents
Introduction
21 CFR 211.165 is a section of the U.S. Code of Federal Regulations under the Current Good Manufacturing Practices
(CGMP) for pharmaceuticals. This rule specifically governs the testing and approval or rejection of drug products, ensuring they meet established specifications before distribution.
Definitions and Concepts
- Finished Drug Products: Medicinal products that have been produced, tested, and are ready for patient use.
- Specification: A defined set of criteria a drug product must meet to ensure its quality, safety, and efficacy.
- Batch Release: The process of approving a product batch after verifying that it complies with CGMP and established standards.
- Analytical Testing: Laboratory procedures used to evaluate the identity, purity, potency, and other quality attributes of drug products.
Importance
The pharmaceutical and biotech industries rely heavily on 21 CFR 211.165 to uphold product quality, patient safety, and regulatory compliance. Non-compliance can lead to product recalls, legal liabilities, and reputational damage. Compliance ensures that drugs released to the market meet stringent quality standards, safeguarding public health.
Key Requirements
- Testing for Conformity: Each batch must be tested to ensure conformity to final product specifications, including identity, strength, and purity.
- Validation of Analytical Methods: Testing methods must be scientifically validated to ensure accuracy, precision, and reproducibility.
- Statistical Sampling Plans: Sampling procedures must follow scientifically sound methods to adequately represent batches being tested.
- Stability Testing: Products must demonstrate stability under specified storage conditions for their intended shelf life.
- Documentation and Recordkeeping: Complete records of all tests and written evaluations must be maintained and accessible for regulatory inspections.
Application
In real-world pharmaceutical and biotech operations, 21 CFR 211.165 is applied in various stages of drug production:
- Quality Control (QC) Testing: QC labs perform analytical tests on batch samples to ensure compliance with CGMP specifications.
- Release of Biologic Products: For biologics, specific assays are used to confirm biological activity and verify absence of contaminants.
- Stability Studies: Stability programs monitor product performance over time in different storage conditions.
- Regulatory Inspections: FDA inspectors scrutinize adherence to the section during facility visits, making accurate documentation critical.
