Analytical Quality Control News

FDA Warning Letter: Missing Testing for Toxic Impurities and Lack of Stability Data in OTC Drug Products

In a recent Warning Letter, the FDA outlines severe GMP deficiencies in the manufacture of OTC hand sanitizers and antibacterial soaps, including missing identity testing, lack of stability data, and absent process validation. Critical raw materials such as glycerin and ethanol were accepted without proper testing – despite their known risk of contamination with diethylene glycol (DEG), ethylene glycol (EG), or methanol, substances that have caused fatal poisoning incidents worldwide.

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Proposal for USP Chapter <320>: NMR-Based Determination of Degree of Hydrolysis and Monomer Ratio in Polyvinyl Alcohols

In the Pharmacopeial Forum, PF 51(3), a proposal for a new chapter <320> NMR Spectroscopy for the Determination of Degree of Hydrolysis for Polyvinyl Alcohol and Vinyl Alcohol Homopolymer, and Monomer Ratio for Vinyl Alcohol and Vinyl Acetate Copolymer has been published for public comment. The commenting period is open until 31 July 2025.

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New ICH Q1 Draft Guideline - What’s Changing in Stability Testing

On 11 April 2025, the new ICH Q1 Draft Guideline “Stability Testing of Drug Substances and Drug Products” was published, marking a comprehensive revision and consolidation of the former ICH Q1A–F and Q5C Guidelines. Against this background, the ECA is offering a compact, 3-hour Live Online Training on 18 June 2025. The training is designed to provide participants with a clear overview of changes, new aspects and interpretations of the upcoming regulatory expectations with respect to the stability strategy.

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New ECA Guidance on Sampling and Sample Management

The ECA Analytical Quality Control Group (AQCG) has published a new guidance document on Sampling and Sample Management. The PDF file is available for free in the AQCG members area. Additionally, a free webinar for all members is scheduled for 17 June 2025.

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Update of USP Chapter <1099> on Content Uniformity in Large Samples

In the current Pharmacopeial Forum, PF 51(3), the USP has published a revised draft of General Chapter <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples. The deadline for submitting comments is 31 July 2025.

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USP Education Webinar on <1058>

Dr. Christopher Burgess, Chairman of the ECA Analytical Quality Control Group (AQCG), will present a webinar titled “Enhancement of General Chapter Analytical Instruments and Systems Qualification; a Full Lifecycle Approach”, organized by USP Education.

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EMA publishes Draft of ICH M13B Guideline on Bioequivalence

The European Medicines Agency (EMA) has published the "ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths biowaiver - Step 2b". Comments on the draft can be submitted until 9 July 2025.

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Public Consultation on ICH M13B Guideline on Bioequivalence launched in Switzerland

As previously reported, the European Medicines Agency (EMA) has published the draft of the ICH Guideline M13B "Bioequivalence for Immediate-Release Solid Oral Dosage Forms". In this context, Swissmedic has announced that stakeholders in Switzerland have the opportunity to submit comments until 9 July 2025.

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BioPhorum publishes Guidance for ICH Q2(R2) and Q14 Implementation

BioPhorum recently published a new document entitled "Best practices for the development, validation and registration of analytical procedures—Implementation of ICH Q2 (R2) and Q14 for biologics."

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Become a Speaker at PharmaLab 2025 - Analytic, Bioanalytic, Microbiology

PharmaLab 2025 - become a speaker at the leading congress on analytics, bioanalytics and microbiology. Meet over 500 colleagues as part of the speaker team in Neuss/Düsseldorf. We also welcome poster requests.

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