On August 12, 2019, the FDA updated its guidance Question and Answers on Current Good Manufacturing Practices – Laboratory Controls to add 3 new questions with answers focused on laboratory tests using chromatographic systems. This level 2 guidance presents a list of technical questions related to laboratory testing, a critical step in the process of verifying drugs are safe to be released on the market. The questions help clarify how standards and samples should and should not be used in chromatographic testing.

This newly update document is part of a Q&A guidance on CGMPs developed as part of FDA’s Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, which clarify statements of existing requirements or policy in the CGMP regulations (21CFR Part 211). It’s my assessment that many of these questions arise from inspection observations, as the topics are among those commonly found (review the observation summaries and data at this web page). It’s another set of guidance that are worth reviewing when updating your policies and procedures or in preparation for inspections.

Text Copyright © 2019 Katrina Rogers