Are you confirming the ID of your raw materials before use?

Manufacturing quality products requires using raw materials that meet your quality standards. 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 component, container, and closure shall be withheld from use until the lot has been sampled, tested or examined and released for use by the quality control unit.

It is imperative to collect samples that aptly represent each shipment of every lot in order to conduct testing or examination. It is required to perform at least one test to confirm the identity of each component of a drug product. Ideally, specific identity tests should be employed, if available. Any lot of component, container, or closure that meets the approved specifications is deemed suitable for use. Conversely, any lot that fails to meet the specifications must be rejected.

A company recently received the following observation:

…. Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.

Specifically, your firm does not perform any identity test for each component used for drug production. In addition, the firm has not established the reliability of the supplier’s certificates of analyses for component specifications and characteristics. The following active pharmaceutical ingredients are examples that were released and used in the manufacturing of the drug product without any testing:

a.         …, supplier lot …, was received and released after review of supplier’s certificate of analysis’ result and copying the results over to an internal form. Quality Control Test Report Form. The raw component was used to manufacture … Lot # ….

b.         … is a concentrate with the active ingredient … used to produce the …. The Bill of Lading shows receipt of …. with lot number … which was released after review of supplier’s certificate of analysis.

To view more observations pertaining to testing raw materials, refer to the following GMP Trends® Issues: 1128, 1127, 1126 and 1125. 

Our new Issue 1132, available today, includes additional observations on laboratory controls, as well as observations on quality systems, manufacturing controls, and medical devices.

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