[Stability Testing related News – vol.5]

◆　Guideline on Quality of biological active substances produced by transgene expression in animals.（10-Jun-13　EMA）

The said guideline was adopted by CHMP. Date for coming into effect is 01 December 2013.

◆　EMA: new Expectations for QPs（05-Jun-13　ECA）

The European Medicines Agency EMA has published a new set of Question and Answers on their website. A whole set of Q&As is dealing with API supplies and the auditing of the respective sites.
In one answer to one of the questions the EMA makes a very clear statement to the role of the Qualified Person, which hasn’t been stated in such a clear way yet: “The responsible QP should ensure that he/she or someone to whom it is delegated is in agreement with the overall recommendation of the final report” and “The QP must not release the relevant medicinal products without knowledge of a positive recommendation from the auditor(s).”

◆　Results of ECA´s Validation Survey regarding the revision of Annex 15（05-Jun-13　ECA）

The European Medicines Agency (EMA) has already issued a concept paper with regard to the EU Annex 15 and asked for comments; Reason enough for the ECA to set up a survey to find out the industry’s thoughts on the planned revision.
The results are quite surprising. Most of the respondents (altogether 287) are moving in a new direction towards to modern process validation approach.
More than 90% would like to have a process validation life cycle.

EMA Questions and answers

◆　Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.（25-Jun-13　FDA）

This guidance provides recommendations that will help API manufacturers, pharmaceutical and medical device manufacturers of finished products, repackers, and others, to better prevent the use of crude heparin that might contain over-sulfated chondroitin sulfate (OSCS)3 or non-porcine ruminant material contaminants.
It is important to monitor the use or development of test methods for crude heparin in addition to those set forth for heparin sodium API in the United States Pharmacopeia (USP). It is also important to identify and control the animal origin of crude heparin and confirm the species origin of heparin.