GMP News - Analytical Quality Control

In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.

In the Pharmacopeial Forum, PF 48(2), a proposal for a slightly revised Chapter <711> Dissolution was published. The purpose of the revision is to include an option of using a new USP Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.

It is proposed to add the porcine simulated gastric and intestinal fluids in the subchapter on solubility measurements in biorelevant media. The new version of the chapter has now been published in the Pharmacopeial Forum, PF 48(2) for public comments.

The World Health Organization (WHO) has published a proposal for a new chapter 1.14.1 Chromatography for inclusion in The International Pharmacopoeia. Comments on this draft working document can be submitted until 25 March 2022.

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian drug manufacturer. During an inspection, it was observed that the firm combined returned capsules from various lots into new batches, resulting in new lots with no uniform character and quality. The FDA also criticizes the firm’s stability programme and validation activities.

Recently the U.S. Food and Drug Administration (FDA) issued a warning letter due to inadequate investigations into out-of-specification (OOS) test results.

In the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> was published. According to the Expert Committee, the aim of the new chapter is to provide an overview of the minimum quality attributes required for starting materials used in the manufacture of synthetic therapeutic peptides.