Last week’s round -up;
01-05 March 2021

published 8 Mar 2021

Rapid implementation of revised sartan Ph. Eur. monographs

Five Ph. Eur. monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), have been aligned with the latest regulatory recommendations issued by the CHMP. The revision concerns a rewording of the “Production” section and deletion of the N-nitrosamines test section. Since the changes concerned are in line with the CHMP recommendations, the Ph. Eur. Commission has published the monographs under the rapid-revision procedure and they will be implemented on the 1st April 2021. The revised monographs can be downloaded from the EDQM website and have also been added to the online and downloadable versions of Supplements 10.4 and 10.5. The revised sartan monographs will be included in the printed version from Supplement 10.6.

UK MHRA publishes major update to GMP requirements for “Specials” manufacturers

The MHRA has made a major update to the manufacture of sterile medicinal products section to add definitions of “aseptic manipulation” and “compounded intermediate for use in further process”, for example parenteral nutrition (PN) manufacture. Guidance has been added on additional risk reducing factors to be used when producing compounded intermediates, and on the elements to be included in a contamination control strategy. Other minor changes to the formatting and numbering of the existing guidance have been made.

The guidance is available at the following link:

FDA Inactive Ingredient Database Update

FDA has improved the functionality of its Inactive Ingredient Database (IID) through the introduction of a quarterly log to track changes in the records and the use of the term “maximum daily exposure” (MDE) instead of “maximum potency.” The quarterly log allows users to track changes made to the IID, such as the MDE for potency replacement, on an on-going basis. The use of the MDE as opposed to “maximum potency” provides applicants with more complete information about the acceptable level of a particular excipient in a drug product. The maximum potency values are being replaced as the algorithmic calculation of MDEs is an on-going process. A webinar presented by Susan Zuk, the Branch Chief of the CDER Office of Pharmaceutical Quality (OPQ) Office of Policy for Pharmaceutical Quality (OPPQ), highlighted the recent progress made to the database and considerations that warrant further attention.

A free recording of the webinar is available and further details may be found at the following link:

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