Top Warning Letter Drug GMP Citations
A presentation by CDER Office of Manufacturing Quality branch chief Maan Abduldayem at the 46th Annual International GMP Conference in Athens, GA 3/8 provided the Center’s “Top Recent Warning Letter Citations” (FY 2019 to FY 2021). They are:
- CFR 211.192 Production record review (cited in 61 Warning Letters): All drug product production and control records, including those for packaging and labeling, should be reviewed and approved by the quality control unit to determine compliance with written procedures before a batch is released or distributed. Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications should be thoroughly investigated.
- 21 CFR 211.100(a) Written procedures; deviations (cited in 61 Warning Letter): (INSERT XXX)Written procedures are required for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
- 21 CFR 211.166(a) Stability testing (cited in 46 Warning Letters): A written testing program is required that should assess the stability characteristics of the drug products. The results of such stability testing should be used in determining appropriate storage conditions and expiration dates.
- 21 CFR 211.84(d) Testing and approval or rejection of components, drug product containers, and closures (cited in 39 Warning Letters):Samples should be examined and tested to verify the identity of each component of a drug product, and each component should be tested for conformity with all appropriate written specifications for purity, strength, and quality.
- 21 CFR 211.165(a) Testing and release for distribution (cited in 35 Warning Letters): For each batch of drug product, an appropriate laboratory determination of final specifications for each drug product should made before product release.
- 21 CFR 211.22(a) Responsibilities of quality control unit (cited in 30 Warning Letters): The quality control should have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
- 21 CFR 211.22(d) Responsibilities of quality control unit (cited in 25 Warning Letters): The responsibilities and procedures applicable to the quality control unit should be in writing and followed.
- 21 CFR 211.67(b) Equipment cleaning and maintenance (cited in 22 Warning Letters): Written procedures should be established and followed for cleaning and maintenance of equipment used in the manufacture, processing, packing, or holding of a drug product.
- 21 CFR 211.160(b) General requirements (cited on 22 Warning Letters): Laboratory controls should include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards.