GMP News - Analytical Quality Control


CMC: FDA publishes Guideline with questions on post-approval modification of single-use materials

With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).



FDA Warning Letter: No Stability Studies for Reworked Batches

In June 2022, the U.S. FDA issued a Warning Letter (WL) to the Spanish company "Bioiberica, SAU" after having inspected its site in January and February 2022.



New Ph. Eur. Chapter on Implementation of Pharmacopoeial Procedures

Ph. Eur. 11.0 has been published in July 2022. Amongst others, the 11th Edition contains the previously announced new general chapter 5.26. Implementation of Pharmacopoeial Procedures providing a 2-step approach.



New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs

The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.



Revision of USP Chapter <1094> Capsules - Dissolution Testing And Related Quality Attributes Published for Comments

In the Pharmacopeial Forum, PF 48(4), a new version of USP Chapter <1094> Capsules—Dissolution Testing And Related Quality Attributes was published. Based on comments received on the version of the chapter official as of December 1, 2020, several revisions are proposed.



USP-NF Stimuli Article on Consistent NMR Terminology

In the Pharmacopeial Forum, PF 48(4), a stimuli article entitled "Consistent Terminology for Advancement of NMR Spectroscopy" was published. According to the authors, the paper builds the foundation for a modular, coherent, and standardized terminology, a condition necessary for a healthy life cycle of research data, including their management and reuse.



FDA Warning Letter: Missing Qualification of Contract Labs for Release

In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.



FDA Warning Letter: Benzene Contamination in Hand Sanitizer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a South Korean manufacturer of OTC drug products. During an FDA laboratory testing of a batch of hand sanitizer, the impurity benzene at unacceptable levels was found. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.



Revision of USP Chapter <761> NMR Spectroscopy and <1761> Applications of NMR Spectroscopy

In the Pharmacopeial Forum, PF 48(4), revisions of USP chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Applications of Nuclear Magnetic Resonance Spectroscopy are being proposed. Comments can be submitted until September 30, 2022.



EDQM: List of Reference Standards Updated

Once again, the list of reference standards, which includes more than 3,000 substances, has been revised and the resulting changes and innovations have been listed in the Newsroom of the EDQM website.



New Pharmeuropa Bio & Scientific Notes Article on Weighing according to the European Pharmacopoeia

In the Pharmeuropa Bio & Scientific Notes, a free online journal of the EDQM, a new scientific article entitled "Weighing according to the European Pharmacopoeia: general considerations and new general chapter 2.1.7. Balances for analytical purposes" was published.



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.



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.


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