FDA Form 483 due to Insufficient Investigations after Out-of-Specification (OOS) Dissolution Results
The U.S. Food and Drug Administration (FDA) published a Form 483 after an inspection at an Indian drug manufacturing side. The lack of control over compression machines settings led to not meeting the dissolution specifications. As the investigations were limited to the directly affected batch only, it is not excluded that other products may be affected by the same problem. Furthermore, the stability program was not followed to complete the testing within the predefined time frame.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.