GMP News - APIs and Excipients

27.09.23

USP: Chapter "Weighing on an Analytical Balance <1251>" published for Comments

Like the USP chapter "Balances <41>", the chapter "Weighing on an Analytical Balance <1251>" has been updated and revised. The new version of this chapter has now been posted on the USP Pharmacopeial Forum website for comment. Comments on this draft, which is based on the previous version from May 2018, can be submitted until 30 November 2023.

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26.09.23

Ethylene and Diethylene Glycol Testing again in Focus of FDA Warning Letters

In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.

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20.09.23

New ZLG Document on Transport Verification Published

At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared GDP relevant document. The German-language resource entitled "Inspektion der Eignung von Transportprozessen" focuses on transport verification and its inspections by the competent authorities.

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20.09.23

USP: Comments possible on the Topic "Balances <41>"

The latest valid version of the USP chapter "Balances <41>" has been substantially revised and is now posted for comment on the USP Pharmacopeial Forum website. This revision follows updates to the USP chapter "Weighing on an Analytical Balance <1251>" and the general chapter "Balances" of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 30 November 2023.

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13.09.23

Draft of Harmonized USP Chapter <701> Disintegration Published for Comments

In the Pharmacopeial Forum, PF 49(5), a proposal of a revised USP General Chapter <701> Disintegration has been published for comments. The chapter was updated as part of the process of international harmonization of the European, Japanese, and United States pharmacopeias. The comments period runs from 01 September to 30 November 2023.

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12.09.23

Critical Quality Attributes for Topical Dosage Forms

A recently issued USP stimuli article describes advances in product quality and performance tests for topical and transdermal delivery systems (TDS). In particular, the article focuses on physicochemical and structural characterization tests for semisolid drug products.

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06.09.23

German Federal Cabinet passes Cannabis Act

The German Federal Cabinet has adopted the draft of an "Act on the Controlled Use of Cannabis and on the Amendment of Further Regulations" (Cannabis Law - CanG).

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06.09.23

U.S. Warning Letter caused by Data Integrity Failures

In August 2023, the U.S. FDA issued a Warning Letter to the US American company "Cosmobeauti Laboratories & Manufacturing Inc." after having inspected its site in March 2023. The significant violations of cGMP regulations for drug products, which are mentioned in the Warning Letter, can be checked here.

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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

EMA issues Concept Paper on modern Manufacturing Techniques used for HMPs

The Committee on Herbal Medicinal Products (HMPC) adopted the Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations. The proposed reflection paper should support the industry in the development and application of modern manufacturing methods regarding herbal preparations.

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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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24.08.23

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

The FDA issued a new guidance to provide general considerations to sponsors developing psychedelic drugs for medical use. According to the agency, there has been growing interest in the therapeutic potential of psychedelic drugs. This is the first FDA guidance that presents considerations for designing clinical trials for psychedelic drugs.

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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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