GMP/GDP News for Excipients (2016)

EMA's new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers
For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to quality. The EMA has recently published the draft of a guideline on that topic which contains a range of clarifications. Read more about the coming requirements on sterilisation of medicinal products, APIs, excipients and final containers and how to document them in the marketing authorisation dossier.

Quality Documentation of API mix in the Marketing Authorisation Procedure
For different reasons, the manufacture of APIs may sometimes require adding excipients. In the context of an authorisation procedure, this practice reveals to be problematic. Read more here about the data required for the quality documentation of a API mix in an ASMF or a CEP.

Ph. Eur. Draft General Chapter 5.24. Chemical Imaging
A draft for a new General Chapter "5.24. Chemical Imaging" has been published for comments in Pharmeuropa 28.2. Deadline for comments is June 30, 2016. Find out more about the proposed new Ph. Eur. general chapter 5.24. Chemical Imaging.

ICH Q3D implemented in the European Pharmacopoeia: Revision of Two General Monographs with Regard to Elemental Impurities
Two general monographs of the European Pharmacopoeia have been revised and published for comment in the newest "Pharmeuropa" edition. Read more about what you will have to consider in future with regard to the control of elemental impurities in pharmaceutical preparations, APIs and excipients.

What are the current Rules for Supplier Qualification?
Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for qualifying suppliers?