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FDA Warning Letter: Missing Licence and other CGMP Violations for Biologicals

The US Food and Drug Administration (FDA) has criticised a manufacturer of biologicals for significant violations of current Good Manufacturing Practices (CGMP) following an inspection. The company is accused of manufacturing and distributing unauthorised biological products.

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Revision of USP chapter <1071> on rapid methods and its effect on other USP chapters

United States Pharmacopoeia publishes an overview of the effects of the revision of Chapter <1071>  “Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach” on other USP chapters and guidance documents.

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Revision of USP <1032> Design and Development of Biological Assays

USP recently published a draft revision of Chapter <1032> Design and Development of Biological Assays, which will be available for comment until the end of January. This chapter is part of 5 USP chapters that deal with the topic of bioassasys.

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Publication of three FDA draft guidelines on donor eligibility for HCT/Ps

The FDA has comprehensively updated its guidelines for ensuring the safety of human cells, tissues and cell-based products (HCT/Ps). With a focus on minimising HIV, HCV and HBV transmission risks, the new guidelines rely on more precise testing procedures and uniform, risk-based donor evaluations. These changes represent progress in quality assurance and infection prevention.

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Revision of USP <1085> "Guidelines on Endotoxin Test"

The USP continues to work on updating its chapters around endotoxin testing and is publishing a proposed revision to Chapter <1085> Guidelines on Endotoxin Test.

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Inadequate Classification leads to Warning Letter

An incorrect classification of a biological product led to a Warning Letter from the FDA, even though there was no CGMP violation.

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Warning Letter for an American Manufacturer of Blood Products

The FDA's inspection of a manufacturer of blood products uncovered significant violations of Current Good Manufacturing Practices (CGMP) for blood and blood components, leading to concerns about the safety, purity, and quality of their products. These violations included inadequate staff training, failure to follow procedures, poor record-keeping, and lack of proper investigation into discrepancies.

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Supporting biopharmaceutical Research and Development for Europe

The European Commission has signed a first investment agreement to support biopharmaceutical research and development as part of the HERA Invest initiative. With funding of €20 million, it is supporting the French company Fabentech in the development of therapeutic antibodies against biological health threats.

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Revision of USP Chapter <1047> on Gene Therapy Medicinal Products

USP <1047> Gene Therapy Products - Proposed revision was published in PF 50 (4) by the USP together with a whole series of further updates and revisions.

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USP follows the 3R Principle - Implementation of new Chapter on recombinant Test Methods

The USP follows suit! Following other pharmacopoeias, the USP is now also publishing a chapter <86> on recombinant reagents for testing for endotoxins, thereby following the worldwide endeavour to reduce the use of animal materials.

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