GMP News - Analytical Quality Control

The EMA has recently extended its Questions and Answers collection with three statements regarding the setting of drug substance specifications for potentially genotoxic, metallic impurities, and solvent residues. More details here.

According to a notice from the EDQM with regard to a meeting of the Pharmacopoeial Discussion Group (PDG) 28 of the 35 General Chapters and 41 of the 61 monographs on excipients are currently harmonised. You will find more about the latest status relative to the PDG working group in this news. The strategies for an efficient management of the different pharmacopoeial requirements (EP, USP, JP) are also the topic at an international Pharmacopoeia conference in Prague.

The MHRA has published a presentation on its website about the expectations of the authority regarding the handling of OOS results in pharmaceutical laboratories. Among other things, the website provides 20 questions and answers on the OOS topic. At ECA's OOS Forum in Prague in June, Di Morris from the MHRA will present the correct handling of OOS results in the microbiological laboratory. Find out more.

The method transfer is a documented process which establishes the evidence that a laboratory is qualified to use an analytical method which has been elaborated in another laboratory. Hereby the evidence must be brought that the laboratory has the knowledge and the ability to perform the analytical method as intended. The USP 35 now includes a new General Chapter <1224>. Read more here in the News.

GAMP is going to update the Laboratory Good Practice Guide. The main objective of the second edition is to align it with the principles in GAMP 5.  One outcome of the new edition is that the seven categories have been discontinued and replaced by the GAMP 5 software categories. The new Laboratory GPG "Risk-Based Approach to GxP Compliant Laboratory Computerised Systems" has gone to press and is scheduled for publication in June. Read more in the news.

So far, chromatographic adjustments haven't been recommended by the USP for the use of gradients in the mobile phase for system suitability tests. In a revised draft for General Chapter <621>, major changes have been proposed in the Pharmacopeial Forum. Read more here.

In the January - February issue of USP'S Pharmacopeial (PF) a stimulus to the revision process was published for USP <1058> on Analytical Instrument Qualification. The proposal is based around a more detailed risk assessment for all apparatus, instruments and systems used in a regulated analytical laboratory. This USP General Chapter <1058> is currently under revision. The GAMP GPG for Laboratory Computerised Systems is also under revision and is due to be published in Q2 this year. You will find more information here.