GMP News - Analytical Quality Control

In the current Pharmacopeial Forum, PF 48(3), a major revision of USP chapter <1724> Semisolid Drug Products—Performance Tests is being proposed. Comments can be submitted until July 31, 2022.

Since the end of April 2022, the second revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" is available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adaptations in Appendices 2 and 3. Appendix 5 has been newly added.

The U.S. Food and Drug Administration (FDA) has published a new version (Revision 1) of its Guidance for Industry on Out-of-Specification (OOS) Results. The original version of the document was published almost 16 years ago, in October 2006.

During its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of general chapter 5.21. Chemometric methods applied to analytical data to be published in Ph. Eur. Supplement 11.1 and be effective as of 01 April 2023.

Also in March, the list of available reference standards, which comprises more than 3.000 substances, was revised - and the resulting changes, innovations and updates were listed in the newsroom of the EDQM website.

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an American drug manufacturer. The company retested failing lots with unvalidated test methods until passing results were obtained. Other deficiencies concern the cleaning validation, the stability program and HPLC data integrity.

During an inspection, FDA inspectors look closely at how quality control handles analytical data that deviates from the specification. Find out what is important to consider when handling OOS results, verifying test methods and checking electronic data.