Analytical Quality Control News

ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for Consultation

On March 24, the drafting process of the new ICH Guideline Q14 Analytical Procedure Development and the revised Guideline Q2(R2) Validation of Analytical Procedures reached Step 2, and both were published for consultation by ICH members.

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USP: Second Stimuli Article on Instrument Qualification published for Comments

In the beginning of March 2022, the stimuli document "Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification - The Role of Measurement Uncertainty Concepts within the AIS - PF 48(2)" has been published on the USP Pharmacopeial Forum website for comment.

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WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies

In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.

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Analytical Procedure Life Cycle - New USP Chapter <1220> published

More than a year after the publication of the draft of Chapter <1220> on Life Cycle Management of Analytical Procedures, the USP has announced the final version for 01 November.

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New FDA Draft Guidance - Microbiological Quality Control of Non-Sterile Medicinal Products

Based on the experience of the past years, the FDA has published a new draft guidance that deals with the microbiological control of non-sterile medicinal products and clarifies it by means of case studies.

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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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