Analytical Quality Control News

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 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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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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Missing Tests and Altered Records: FDA Warns Chinese OTC Manufacturer

A recent FDA Warning Letter to a Chinese OTC manufacturer highlights serious deficiencies in analytical testing, inadequate quality oversight, and multiple data integrity issues. These include missing data, discrepancies between original and re-written testing records and certificates of analysis (COAs), and the use of correction fluid (white-out) to alter laboratory documentation.

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Become a speaker at PharmaLab 2025 - Analytics, Bioanalytics, Microbiology and more

The 13th PharmaLab Congress from November 24-28, 2025 will take place as usual in Neuss/Düsseldorf with two pre-conference workshops and several parallel conferences. As always, it offers you the opportunity to become part of the speaker team and submit a presentation to share your knowledge with colleagues and discuss the respective experiences. So, become part of the team of speakers - and submit your proposal for a presentation via our online form.

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Inadequate Dissolution Testing and Process Validation Trigger FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter due to CGMP violations related to combination products. Key violations include inadequate controls to ensure the sterility of drug products, deficient dissolution testing, and a lack of process validation.

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