The possible Impact of Artificial Intelligence on the Role of the Qualified Person
Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.
Semisolid Drug Product Quality and Performance Tests
The USP adopted the revised general chapters <1724> Semisolid Drug Products - Performance Tests and <1912> Measurement of Yield Stress of Semisolids. In particular, chapter <1724> now also includes information on in vitro permeation tests (IVPTs).
Series of FDA Warning Letters due to inadequate Testing of Glycerin and Other High-Risk Drug Components
Just recently, we reported on a Warning Letter regarding a manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. The FDA has now published a whole series of Warning Letters that revolve around the same topic.
EDQM: Supplement 11.3 to the European Pharmacopoeia available
Supplement 11.3 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 1 January 2024. According to the EDQM timetable, this supplement will be followed by versions 11.4 to 11.8, with the final implementation date planned for July 2025.
FDA Warning Letter: Inadequate Investigation of Humidity Excursions
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. During an inspection at an Indian company, the FDA investigators observed several GMP violations concerning inadequate investigation of humidity excursions, data integrity deficiencies, and inadequate testing of component lots used to manufacture the OTC drug products.
Identity Testing of Glycerin in Focus of an FDA Warning Letter
At the beginning of August, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. As in several cases in recent months, it is again about a US manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. In addition, a number of other CGMP violations are documented.
As recently reported in our News, the Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" has been updated again. The EDQM has now defined the resulting measures for CEP holders and listed them in its Newsroom.
USP-NF Stimuli Article on Chromatographic Screening for Extractables and Leachables
In the Pharmacopeial Forum, PF 49(4), a stimuli article entitled "Proposals for the Development, Composition, and Routine Use of System Suitability Standard Mixtures in Support of Chromatographic Screening for Organic Extractables and Leachables" was published.
Supplement 11.2 to the European Pharmacopoeia (Ph.Eur.) came into force on 01 July 2023 and contains several updated monographs. These include five updated excipient monographs, which now include the so-called "functionality-related characteristics (FRCs)" section. In total, there are now more than 100 Ph.Eur. Monographs that include this section.
FDA Warning Letter: Using non-validated and not appropriate Test Methods from an Internet Search is not a good Idea
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. The company in question manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers. The list of GMP violations is quite extensive and concerns, among others, QU oversight, handling of out-of-specification (OOS) results, identity testing, and laboratory controls in general.
EDQM: Policy for CEP Applications published for Comments
In June, the draft Certification Policy Document PA/PH/CEP(04) 1, 6R "Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use" was published on the EDQM website for comments. Comments and remarks on this draft can be submitted until 15 September 2023.
Ph. Eur. Monographs for Cannabis Flower and CBD adopted
The EDQM recently announced that the final Ph. Eur. Monographs for Cannabis flower and Cannabidiol (CBD) will be published in Ph. Eur. Supplement 11.5 with an implementation date of 1 July 2024. Will it be a step forward to EU harmonization of Quality Requirements?
A revised version of the Ph. Eur. general monograph Pharmaceutical Preparations has been published. In particular a reference to the general Ph. Eur. chapter Contaminant pyrrolizidine alkaloids (2.8.26) has been added.
In June 2023, the U.S. FDA issued a Warning Letter to the Chinese company "Chengdu KeCheng Fine Chemicals Co., Ltd.". According to the Warning Letter, the company is registered within the USA as an API manufacturing facility, which shipped APIs to the U.S. several times.