1Laboratory and QC controls
Your firm 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 standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA…
2Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
3Aseptic processing and sterility assurance
Your written procedure SOP-CAPS-4000582 states, “Action level results are documented using FRM-CAPS-4000302… ISO 5, ISO 7, and ISO 8 action level result investigations are further documented on RPT-CAPS-4000048 as appropriate.” This procedure does not appear to adequately ensure a thorough investigation, that includes implementation of appropriate corrective and preventive actions, will be performed each time action level microbial contamination is recovered within a classified area. In addition, in response to the microbial contamination recovered in your ISO 5 aseptic processing areas, you have not provided current environmental and personnel monitoring results of classified areas, including ISO 5 aseptic processing areas.
4Aseptic processing and sterility assurance
You have not further evaluated, or provided data to demonstrate, your firm’s rapid sterility test method is suitable for its intended purpose. Therefore, there is no assurance that your rapid sterility test method is able to provide valid results prior to release of each drug product lot. In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw…
