Analytical Quality Control News

Warning Letter regarding Insufficiencies Around Access Control

During an inspection the FDA found insufficiencies around access authorization. Read more about remediation activities required by the US FDA. 

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Covid-19 Vaccine Mix-Up in the US - what's behind it?

It has been recently reported in the press that there was a mix-up in the manufacturing of the J&J Covid-19 vaccine at a contract manufacturer. Already one year before, considerable quality deficiencies were found at the site. Now the site had to stop producing for now.

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UK Recognition of EU/EEA Batch Testing does not end on 1 January 2023

A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.

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A Lifecycle Approach for Analytical Instrument and Systems Qualification

In July 2018, the ECA Analytical Quality Control Group published version one of its guideline on Analytical Procedure Lifecycle Management (APLM) in support of the development of USP <1220> and the ICH revision of Q2(R2) and the newly proposed Q14.

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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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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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Brexit: Industry should keep Timelines for Batch Testing Facilities

The EMA points out that - independent from the Brexit postponement - MAHs should use the remaining time to complete all necessary preparations.

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Is an Identity Test needed for the content of all Containers?

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

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Data integrity still in the focus of FDA: new warning letter to Japanese API manufacturer

The topics data and data integrity are still in the focus in FDA inspections. Find out more about the details of a warning letter to Japanese API manufacturer Yuki Gosei Kogyo Co. Ltd.

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FDA warning letter due to non-compliance with specifications and ID testing

Drug manufacturer IDT Australia Ltd. received an FDA warning letter in May 2018. It was criticised during the FDA inspection that OOS results of assay determinations had not been investigated and that a batch had been released even though three consecutive identity tests had failed. Read more about the IDT Australia FDA warning letter here.

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