GMP News - Analytical Quality Control

08.01.20

Ph. Eur. Draft Chapter for PA Contaminants in Herbal Drugs

A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of  Pharmeuropa. The scope of this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and herbal medicinal products.

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27.11.19

Cannabis Monograph in the Swiss Pharmacopoeia

Supplement 11.3 of the Swiss Pharmacopoeia (Ph. Helv.) includes a new monograph on Cannabis Flowers. 

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20.11.19

Nitrosamines in Elastomers?

An USP Stimuli article on Elastomeric Components for Inhalation Packaging / Delivery Systems has been published in Pharmacopeial Forum, proposing to test for nitrosamines in elastomeric components used for inhalation products.

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30.10.19

Updated Ph. Eur. Chapter on plastic containers

A revision of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa.

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24.10.19

How to find the key to Ph. Eur. Monographs?

The Ph. Eur. provided a sample monograph to clearly show which information is included in and how to work with a Ph. Eur. monograph.

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24.10.19

Warning Letter: Deficiencies in Validation and OOS

Once again, an Indian pharmaceutical manufacturer has received a Warning Letter from the US-American FDA due to deficiencies discovered during an inspection. The Letter focuses on deficiencies in the validation and the handling of OOS results in the laboratory. Read more here

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16.10.19

Nitrosamine contamination: EMA requests risk evaluation for drug products containing chemically synthesised APIs

The EMA has published three further statements on nitrosamine. Find out what marketing authorisation holders of drugs with chemically synthesised APIs ought to do regarding potential nitrosamine contamination.

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16.10.19

Japanese Pharmacopoeia - Draft Chapter of alternative Endotoxin Testing

The Japanese Pharnacopoe has published a new chapter draft of "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay" for comment.

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16.10.19

Ph. Eur. 2.4.20. Determination of elemental impurities

A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa.

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09.10.19

From Valsartan to Ranitidine: Nitrosamine Impurities and the Measures taken by the EMA and the EDQM

In June 2018, when it became known that the antihypertensive medicinal product Valsartan contained nitrosamines, no one had any idea how widespread these unwanted side-products were. Read more here to find out what action the EMA and EDQM have taken in the past and in response to the latest cases of nitrosamine contamination.

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08.10.19

Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

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08.10.19

FDA publishes Q&A on Internal Standard Responses in Chromatography Bioanalysis

In support of sponsors, applicants and research institutions, the FDA examines in more detail the variability of internal standards in analytics and their consequences. The authority has now published a document entitled "Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers".

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26.09.19

Official Danish Cannabis-Monograph

Denmark has published its official pharmacopoeial monograph for Cannabis: Cannabisblomst (Cannabis flos).

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18.09.19

Warning Letter due to Cross Contamination

In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.

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04.09.19

USP Packaging Standards

The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.

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