GMP News - Analytical Quality Control

In the beginning of March 2022, the stimuli document "Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification - The Role of Measurement Uncertainty Concepts within the AIS - PF 48(2)" has been published on the USP Pharmacopeial Forum website for comment.

To address inquires and to give USP more time to engage with stakeholders regarding the suitability of making <665> an applicable general chapter, the USP intends to extend the official date for <665> to May 1, 2026.

The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled Collecting and Providing 702(b) Portions of FDA Official Samples. The draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act).

The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. This article provides a brief overview about the automation in dissolution testing.

Since the beginning of 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" has been published for comment on the USP Pharmacopeial Forum website.

The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.

Active and analytical markers are used  for release and stability testing of herbal substances, preparations and HMPs. The EMA provides guidance on the selection of markers in a reflection paper on markers used for quantitative and qualitative analysis.