FDA publishes ICH Q4B – Annex 6 on Uniformity of Dosage Units

GMP News: FDA publishes ICH Q4B – Annex 6 on Uniformity of Dosage Units

http://www.gmp-compliance.org/enews_4480_FDA-publishes-ICH-Q4B—Annex-6-on-Uniformity-of-Dosage-Units_8438,8571,Z-QCM_n.html

On 16 June 2014, the FDA published the ICH harmonised Guideline entitled “Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter (Q4B Annex 6)”. This ICH Guideline thus came into force in the USA, too.

The objective of the ICH Q4B Working Group is to reach mutual recognition by regulatory authorities in the ICH regions for all testing methods listed in the ICH Q6A Guideline on Specifications. Through this, comparable testing laid down in the different pharmacopeias shouldn’t be performed separately when it has been assessed by the authorities that those are similar and interchangeable.

The Annex 6 states that the following official texts :

• Ph.Eur. 2.9.40 (Uniformity of Dosage Units
• JP 6.02 Uniformity of Dosage Units
• USP General Chapter <905> Uniformity of Dosage Units