Pharmacy Courses

FDA Quality Audits and Critical Observations

2022 - 2023 USFDA trend says on top 5 observations category as follows:

1. 21 CFR 211.22(d) - Procedures not in writing, fully followed

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. 

2. 21 CFR 211.192 - Investigations of discrepancies, failures

There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed

3. 21 CFR 211.100(a) - Absence of Written Procedures

Your firm failed to establish [adequate] written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

4. 21 CFR 211.160(b) - Scientifically not sound laboratory controls

Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality, and purity

5. 21 CFR 211.63 - Equipment Design, Size and Location not appropriate

Equipment used in the manufacture, processing, packing, or holding of drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance].

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Resource Person: Jegan Israel

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