Last week’s round -up;
14-18 June 2021

published 21 Jun 2021

Draft PIC/S EU Annex 16 on batch release by QPs

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) intends to incorporate the EU GMP Annex 16 on batch release by a qualified person (QP) into a PIC/S guideline. The aim of PIC/S is for non-EU/EEA members to incorporate Annex 16 into their regulatory systems. The decision to incorporate Annex 16 is a result of the memorandum of understanding signed between the EMA and PIC/S following the revision of Annex 16 in 2016. The draft PIC/S Annex 16 is currently under consultation which is focussed on the non-EU/EEA members of PIC/S, however, the consultation is also open to the public until 15th September 2021.

New EMA Deferasirox product-specific bioequivalence guidance

The EMA has released a new product-specific bioequivalence guidance for Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg) and granules (90 mg, 180 mg and 360 mg). The guidance comes into effect on the 1st January 2022. An overview of the comments received during the public consultation stage of this new guidance has also been released.

New USP harmonized chapter on visual inspections proposed

Pharmaceutical industry officials have proposed that the USP, together with input from the Ph. Eur. and Japanese Pharmacopoeia, develop a new harmonized chapter on visual inspections of parenteral drugs that would address current testing gaps. The proposed chapter would allow for more robust detection of visible particles in parenteral drugs, which is a common reason for recalls and warning letters in the US. The harmonised compendial chapter would include the use of ‘universally available standards’ to train inspectors, qualify the methods and validate results.

Further information on the recommendations may be viewed at the following link:

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