Your firm manufactures over-the-counter (OTC) (b)(4) drug products, such as, (b)(4). Your firm failed to adequately test your (b)(4) drug product for identity and strength of active ingredients prior to release and distribution.
In your response, you state that you will perform an assay test of your (b)(4) for (b)(4) with a validated analytical method. Your response is inadequate. You failed to provide sufficient details such as your testing procedures or a risk assessment of products released without appropriate assay testing.
Because you lacked adequate testing of each batch of your drug product, you do not know whether they conform to all appropriate finished product specifications and are suitable for release and distribution.
2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following:
Appropriate production and process controls, including an adequate process validation program designed to assure drug products manufactured have the identity, strength, quality, and purity purported or represented to possess (21 CFR 211.100(a)).
Scientifically sound and appropriate test methods and standards used for testing your drug products (21 CFR 211.160(b)).
Complete data derived from standard preparation, sample preparation, and assay testing of your drug products was properly documented and retained (21 CFR 211.194(a)).
Adequate investigations and deviations (21 CFR 211.192).
Adequate cleaning and maintenance procedures, including an appropriate cleaning validation program for your non-dedicated manufacturing
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