Last week’s round -up;
11-15 October 2021

Pharmeuropa 33.4 Just Released

Pharmeuropa 33.4 has just been released and is available for public consultation until the 31st December 2021. It consists of 41 draft monographs including the following:

· 2.2.35. Osmolality

· 2.9.48. Particle size and shape determination by image analysis

· Fluorocholine (18F) injection

· Monoclonal antibodies for human use

· Oxygen (98 per cent)

· Somatropin concentrated solution

· Somatropin powder for injection

· Technetium (99mTc) sestamibi injection

· Winter ulcer vaccine (inactivated, oil-adjuvanted, injectable) for salmonids

https://bit.ly/RealCMC-3aGEI5q

USP General Chapter <1220> Analytical Procedure Life Cycle

The USP has published General Chapter <1220> Analytical Procedure Life Cycle, ahead of the official publication posting to allow stakeholders additional time for reading and understanding the new chapter. This new chapter covers the validation activities throughout the life cycle of an analytical procedure and will be incorporated into USP–NF 2022, Issue 1 on Nov. 1, 2021 and will become official on the 1st May 2022.

https://bit.ly/RealCMC-3iZNG2i

Ph.Eur Supplement 10.7

Ph. Eur. Supplement 10.7 is now available and will be applicable in 39 European countries from the 1st April 2022. Supplement 10.7 is included in the 2022 subscription to the 10th Edition of the Ph. Eur.

https://bit.ly/RealCMC-3lvyRWM