GMP News - Analytical Quality Control

06.09.23

WHO Draft Working Document on Biowaiver Project published for Comments

The World Health Organization (WHO) has published a draft working document entitled WHO Biowaiver Project - Prioritization exercise of active pharmaceutical ingredients for cycle VI (2024) and preliminary results from cycle V (2023). The deadline for submitting comments is 10 September 2023.

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31.08.23

Denmark clarifies Status of the Ph. Eur. Cannabis Monograph

The Danish Medicines Agency clarified that the Danish monograph for Cannabis Flower will become invalid and removed from the Executive Order on Danish Drug Standards once the Ph. Eur. Cannabis monograph becomes official.

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31.08.23

USP adopts new Chapter on Pyrrolizidine Alkaloids

The USP adopted the new general chapter <1567> Pyrrolizidine Alkaloids as Contaminants. Twenty-eight PAs are selected to be monitored and manufacturers of herbal medicinal products should use a risk-based approach for determining appropriate limits and testing requirements.

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31.08.23

Proposed Product Quality Tests for Food Supplements

The USP proposed a new General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests in the Pharmacopeial Forum. The chapter is intended as an informational chapter, not as a requirement for compliance.

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30.08.23

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.

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24.08.23

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).

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23.08.23

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.

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16.08.23

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.

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16.08.23

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.

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09.08.23

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.

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09.08.23

EDQM: Nitrosamines and CEPs

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.

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27.07.23

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.

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26.07.23

EDQM: Excipient Monographs

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.

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26.07.23

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.

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25.07.23

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.

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