FDA Warning Letter: Root Cause of Benzene Contamination not unterstood
The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. An OTC manufacturer received information indicating that the finished drug products produced with isobutane propellants were contaminated with benzene. The company's own analyses as well as results of the FDA laboratory testing confirmed the presence of this impurity. The company failed to perform adequate investigations and so far, the root cause of the benzene contamination is not understood.
Biological Reactiviy - USP Chapter is undergoing Revision
The USP has recently published a revision of its Chapter <87> "Biological Reactivitiy Tests, In Vitro" for comments. One of the objectives is a better alignment with other relevant USP chapters.
New Definition of Pharmaceutical Grade Plastic Packaging Materials
The proposed USP General Chapter <1031> The Biocompatibility of Pharmaceutical Packaging Systems and their Materials of Construction has been published for comment in the current issue of Pharmacopeial Forum. It outlines a risk-based approach to biocompatibility evaluation.
WHO: Excipients GMP Guideline published for Comments
In March 2023, the WHO published the first draft of the guideline "WHO good manufacturing practices for excipients used in pharmaceutical products" on its website for comments. The public comment period ends on 26 May 2023.
FDA Warning Letter: Distribution of OOS Batches and Lack of Stability Data
The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a OTC drug manufacturer in Mexico. No procedure to handle OOS results was in place, and drug product with OOS results were released and distributed. There was also a lack of stability data and the quality unit did not provide adequate oversight.
USP Draft Chapters for Glass and Plastic Packaging Systems
The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.
Pharmeuropa: Revised Chapter 2.9.1. "Disintegration of tablets and capsules" published for comment
In the Pharmeuropa issue 35.2, a proposal for a revised chapter 2.9.1 "Disintegration of tablets and capsules" was published. The deadline for submitting comments is 30 June 2023.
In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document providees numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.
In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.
FDA Warning Letter to Indian Manufacturer: Glycerine used in Manufacturing not Tested according to USP
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an Indian company, registered as a manufacturer of OTC and homeopathic drug products. Some of the formulations contain high percentages of glycerin, but this high-risk component was not adequately tested according to the USP requirements. Thus, it was not ensured that the relevant safety limits for the levels of diethylene glycol or ethylene glycol were met.
Hop (Humulus lupulus) is commonly known for its use in brewing beer. However, it is also used as a herbal drug. The Ph. Eur. Monograph Hop Strobile has now been proposed for revision.
FDA Warning Letter to Californian Drug Manufacturer
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturer in California. The FDA blames the company of various CGMP violations, particularly in the areas of release testing, sampling, stability testing and process validation.
Laboratory Data Integrity issues once again caused a Warning Letter
In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.
The International Pharmacopoeia (Ph. Int.) is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation. Now, the 11th Edition of the Ph. Int. has been published.
New JP Ultraviolet-Visible and Infrared Reference Spectra Published
In March 2023, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published the "JP Drafts (March 2023) No.2 ". In this context, five new Ultraviolet-visible and Infrared reference spectra were published.