FDA Adds New Q&As to Lab Controls Section of CGMP Guidance

Regulatory NewsRegulatory News | 14 August 2019 |  By 

The US Food and Drug Administration (FDA) on Wednesday added three new questions and answers to its Laboratory Controls questions and answers (Q&A) on Current Good Manufacturing Practices (CGMP) guidance. The new Q&As discuss instrument calibration standards for chromatographic systems, system suitability and trial injections.
On the issue of trial injections, where a sample of a lot is injected into the chromatographic system with the intention of obtaining an unofficial passing or failing result, FDA says it is never appropriate to perform such trials. FDA has sent warning letters to companies citing the use of such trial injections and storing the data separately from the reported test result data.

“The injection of trial samples is not acceptable, in part, because all data from analysis of product samples must be retained and reviewed,” FDA says in response to question 17. “FDA considers it a violative practice to perform a trial injection (including under the guise of column conditioning). FDA also considers it a violative practice to use an actual sample in test, prep, or equilibration runs as a means of disguising testing into compliance.”
As for system suitability, FDA says that it’s expected “to be checked using qualified primary or secondary reference standards and any materials necessary to ensure adequate method performance.”
A new batch of highly pure reference standard material should be qualified against the primary reference standard, but finished dosage forms or active pharmaceutical ingredients (APIs) that have not been qualified as reference standards should not be used for system suitability testing, FDA’s answer to question 16 says.
“All data — including obvious errors and failing, passing, and suspect data — must be in the CGMP records and subject to review and oversight,” FDA adds.
And for instrument calibration standards, the agency explains how they should be chosen from highly purified materials that are “well characterized and can be accurately weighed.” Finished dosage forms “generally should be avoided as standards because excipients in the finished dosage form may interfere with analysis,” the answer to question 15 of the Q&A adds.
Questions and Answers on Current Good Manufacturing Practices—Laboratory Controls


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy