1Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Your firm does not have adequate stability testing data to demonstrate that the microbiological properties of your drug products meet established specifications and that they remain acceptable for the duration…
2Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm failed to test incoming raw materials including active pharmaceutical ingredients (e.g., (b)(4) ) used to manufacture your drug products to determine their identity, purity, strength, and…
3Quality unit oversight
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) You lacked adequate quality unit (QU) oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Establishment of adequate production procedures and process control to assure your drug products have…
4Laboratory and QC controls
Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms. Your firm also failed to establish laboratory controls that 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…
5Material and supplier control
Your firm failed to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures (21 CFR 211.80(a)). Your firm approved “ (b)(4) ” for use as a component in your drug products. For example, “ (b)(4) ” is approximately (b)(4) % of your (b)(4) drug product. At a minimum, you must use (b)(4) (refer to USP (b)(4) ) to…
