GMP/GDP News for Excipients (2015)

Draft of new Ph. Eur. Chapter "Co-Processed Excipients" published
A draft of a new Ph. Eur. chapter  "Co-Processed Excipients" has been published in Pharmeuropa 27.4 with deadline for comments on December 31, 2015. Find out more about the proposed requirements for co-processed excipients.

Ph. Eur. Chapter 5.15. Functionality-related characteristics of excipients
Pharmeuropa 27.4 comprises a draft of Ph. Eur. Chapter 5.15. "Functionality-Related Characteristics of Excipients" - covering the critical quality attributes (CQAs) of excipients. Find out more about the Ph. Eur. Chapter 5.15 draft.

Revision of the ICH Guideline Q3C: New toxicological Data for Methyl Isobutyl Ketone and Triethylamine
The guideline ICH Q3C on residual solvents is one of the most frequently revised ICH documents as a result of new scientific findings. The draft ICH Q3C(R6) was recently published. Find out here what manufacturers of active pharmaceutical ingredients and excipients must observe with regard to toxicity and solvents.

Elemental impurities - A database to facilitate the risk assessment of active ingredients and excipients
One of the main demands of the Guideline ICH Q3D is to carry out risk assessments on metallic impurities. A database with analytical data provides a valuable support. Learn more about the data sharing using the new elemental impurities database.

The new requirements of the "Guidelines on the formalised risk assessment for excipients"
The new Guidelines for good manufacturing practice for excipients pack a punch. In parts the requirements go far beyond the terms of the guideline draft of February 2013. Read here what pharmaceutical companies have to observe from now on when ascertaining the appropriate good manufacturing practice for excipients by means of a formalised risk assessment.

The "Industry Coalition" gives practical advice for the control of elemental impurities in active substances and excipients
The implementation of the Guideline ICH Q3D provides a great challenge for both drug manufacturers and active substances producers. Here, you can see the practical advice that the "Industry Coalition" makes available for the Control of Elemental Impurities.