Saturday, 28 March 2015

European Pharmacopeia updates

Some updates of interest in relation to the European Pharmacopeia:

European Pharmacopoeia 8th Edition - Supplement 8.4 (implementation date 1st April 2015)

General Chapters

The following general chapters are being revised: Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components

3.1.10  Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable, aqueous solutions

3.1.14  Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusions

3.2.1    Glass containers for pharmaceutical use                                            

It has been decided to further emphasise the need for control of specific components that may be toxic for chronic use and for vulnerable patient groups. The statements in the definition section of Parenteral preparations (0520), in chapter 3.2.1. Glass containers for pharmaceutical use and in chapter 3.2.2. Plastic containers and closures for pharmaceutical use have therefore been supplemented.

5.12     Reference standards                                                                          

General revision to update chapter to reflect recent advances in pharmaceutical reference standards, including harmonisation with the specifications and definitions of the corresponding ISO Guides (i.e. ISO Guides 30 and 34) and introduction of:

- the definition of international standards based on WHO Technical Report Series 932,
- herbal reference standards (HRS),
- biological reference preparations (BRP) and chemical reference substances for biologicals.

Posted by Tim Sandle