Wednesday, 1 April 2015

Proposed updates to the European Pharmacopeia

A new edition of Pharmeuropa  - 27.1 – has been published.

Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months. Comments received are processed by EDQM, at this stage the draft can be amended and republished. If no further revision is required the draft monograph is proposed to the European Pharmacopoeia Commission if adopted an implementation date is given and this is about one year after the adoption of the monograph. The monograph is then published in the European Pharmacopoeia (or supplement). The monograph is published about 6 months after adoption.

Items of interest include:

5.1.6    Alternative methods for control of microbiological quality

The chapter has been completely revised and rewritten to take account of technological developments in alternative methods.

2.4.8    Deletion of the test for heavy metals


A list of the texts impacted by the deletion of the test for heavy metals (2.4.8) is published for public consultation. Due to the large number of texts, deletion of the test from individual monographs will be implemented in the 9th Edition (9.0) of the European Pharmacopoeia (1 January 2017).

Water for injections (0169)

A revision of the monograph is proposed to take into account current manufacturing practices using methods other than distillation for producing water of injectable quality.

Posted by Tim Sandle