Publication of Level 2 guidance revision: Questions and Answers on Current Good Manufacturing Practices — Laboratory Controls

Publication of Level 2 guidance revision: Questions and Answers on Current Good Manufacturing Practices — Laboratory Controls

The FDA has added three new questions and answers, numbers 15 – 17, to the Laboratory Controls sectionof the Questions and Answers on Current Good Manufacturing Practices (CGMP) guidance. The new questions and answers discuss instrument calibration standards for chromatographic systems, system suitability, and trial injections.

Because drug manufacturers rely, in part, on laboratory testing to verify the quality of drugs before introduction into the market place (or further manufacture), it is essential that analytical procedures are correct and strictly followed. The accuracy of test results rely on appropriate use of standards and prepared samples in executing the test method. The Q&As are intended to make clear how standards and samples should and should not be used in chromatographic testing.

As part of the CGMP initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, FDA developed this question and answer resource on CGMP. This format is intended to provide timely answers to questions about the meaning and application of CGMPs for human, animal, and biological drugs, and to share these widely. These questions and answers clarify statements of existing requirements or policy that are minor in nature, and as such, are considered Level 2 guidance.