Raw material testing is essential to ensure the identity, strength, quality, and purity of the products that you produce. According to the Code of Federal Regulations (21 CFR 211.84, Testing and approval or rejection of components, drug product containers, and closures), each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.
At least one test shall be conducted to verify the identity of each component drug product. Each component shall be tested for conformity with all appropriate written specifications. A Certificate of Analysis may be accepted from the supplier, provided at least one specific ID test is conducted and the company has validated the supplier’s test results.
A company recently received the following observation:
…. Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.
Specifically, you do not conduct any incoming API testing to verify the identity and quality of API and/or raw materials received at your facility. You stated that you have not performed supplier qualification and used the supplier’s certificate of analysis (CoA) in lieu of testing without indicating the manufacturer’s name and testing completed by it.
Your firm’s procedures, SOP …, “Sampling and …” stated that test samples are requested for each order. However, you stated that there was no testing being performed by your company for the incoming API and/or raw materials.