Analytical Quality Control News

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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MHRA Class 2 Recall due to Blister Pack Mislabeling

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall due to a critical labeling error in one batch of Paracetamol 500 mg tablets. The blister packs inside the affected cartons incorrectly state 'Aspirin 300 mg Dispersible Tablets' instead of 'Paracetamol 500 mg'. This incident reveals a failure in the Quality Management System (QMS) and a lapse in oversight by the Qualified Person (QP), while also highlighting the important role of wholesalers and pharmacies in promptly removing affected batches to prevent medication errors.

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OTC Drug Production Ceased after FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter following an inspection that uncovered serious GMP deficiencies in the manufacturing of an OTC drug product, including missing release testing, lack of stability data, and inadequate quality oversight.

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