GMP News - Analytical Quality Control

15.06.22

Proposed Revision of USP Chapter <711> Dissolution Canceled

The Dosage Forms Expert Committee intends to revise USP General Chapter <711> Dissolution. Based on the comments received, the previously proposed revision, published in Pharmacopeial Forum 48(2) in March 2022, has been canceled. It is expected that a new proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 48(6) in November 2022.

more

08.06.22

Several Revised Chapters on Chromatographic Methods Adopted

During its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted several new and revised texts and monographs for publication in Ph. Eur. Supplement 11.1, including several general chapters on chromatographic methods.

more

01.06.22

Microbiological Quality of Herbal Substances

The USP Botanical Dietary Supplements and Herbal Medicines Expert Committee is working on a new USP General Chapter <1114> Ensuring Microbiological Quality of Articles of Botanical Origin.

more

01.06.22

Accuracy, Specificity and Reproducibility of Analytical Test Methods in the Focus of a FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a warning letter to an American manufacturer of OTC drug products. Among others, the analytical test methods had not been validated for accuracy, specificity, and reproducibility. Further violations concern the process validation and OOS investigations.

more

01.06.22

Major Revision of USP Chapter <1724> Semisolid Drug Products Performance Tests Published for Comment

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.

more

25.05.22

Revised USP Chapter <831> Refractive Index Published again for Comments

In the Pharmacopeial Forum, PF 48(3), a new proposal of USP Chapter <831> Refractive Index has been published for comments. The text has been revised again to take into account the comments received on the previous proposal published in PF 47(3).

more

25.05.22

New Version of the ICH Q3D Guideline for Impurities published

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.

more

25.05.22

FDA Warning Letter: Deviation from USP Compendial Methods

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American manufacturer. The firm produces a United States Pharmacopeia (USP) article. The core problem was that the company deviated from the USP for analytical testing, but could not adequately demonstrate that the method is equivalent or better than the current USP compendial method.

more

25.05.22

FDA Updates Guidance on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

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.

more

18.05.22

Elastomers for Pharmaceutical Packaging and Manufacturing

Following the recently adopted USP general chapter <665> for plastic materials used in manufacturing, the USP now published two draft chapters for elastomers for pharmaceutical packaging and manufacturing.

more

18.05.22

Chapter 5.21 "Chemometric Methods Applied to Analytical Data" to be Published in Ph. Eur. 11.1

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.

more

11.05.22

How to Demonstrate Comparability of Analytical Procedures

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.

more

05.05.22

EDQM updates List of available Reference Standards

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.

more

04.05.22

Revised Technical Guide for Metals and Alloys

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.

more

27.04.22

FDA Warning Letter: Testing into Compliance using Unvalidated Test Methods

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.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics