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
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.
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.
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.
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".
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.
Fundamental GMP Deficiencies at US-American Pharmaceutical Manufacturer
During the inspection of a pharmaceutical manufacturer in the USA, the FDA discovered fundamental GMP deficiencies which concern - among other things - cleaning of equipment, cleaning validation, the water system and the stability programme.
FDA's Answers to questions on GMP-compliant Chromatography in the Quality Control Laboratory
The FDA has clear expectations about cGMP compliance in an analytical laboratory. Read more about what the cGMP-compliant running of chromatographic systems in a quality control laboratory should look like.