Analytical Quality Control News

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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EMA publishes four new product-specific Bioequivalence Guidance

The European Medicines Agency (EMA) has published the finalised product-specific bioequivalence guidelines for Budesonide and Tolvaptan. The documents will come into effect on 1 September 2025.

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Pharmeuropa: New Chapter on Evaporative Light-Scattering Detection published for Comment

The Pharmeuropa issue 37.2 includes a draft for a new chapter 2.2.62, Evaporative Light-Scattering Detection. Comments on the draft can be submitted until 30 June 2025.

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FDA Warning Letter: Missing Ongoing Stability Program for Biotech APIs

In March 2025, the U.S. FDA issued a Warning Letter (WL) to the Indian company "Aspen Biopharma Labs Private Limited" after having inspected its site in September 2024 and criticised the company's stability program.

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Pharmeuropa: Four Draft Chapters on Elemental Analysis Published for Comment

In the Pharmeuropa issue 37.2, four draft chapters on elemental analysis methods were published for public comment: 2.2.22. Atomic emission spectrometry, 2.2.23. Atomic absorption spectrometry, 2.2.57. Inductively coupled plasma-atomic emission spectrometry, and 2.2.58. Inductively coupled plasma-mass spectrometry.

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