Analytical Quality Control News

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.

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.

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."

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.