GMP News - Quality Assurance

The International Pharmaceutical Quality (IPQ) Journal - one of the most important Journals in the GMP and regulatory environment - reports in a very detailed article, that ICH's "Development and Manufacture of Drug Substances" Q11 Guideline is close to being cleared in Step 4 after some significant changes to the Step 2 draft by the Expert Working Group (EWG). Read more here.

The FDA published a Draft Guidance for Industry about the Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components. Read more.

To streamline the procedure for recall classifications and to save time and resources, FDA's CBER published the Direct Recall Classification Program for Blood and Plasma (DRC). More details can be found here.

Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. Please read more about the document here.

From 7-9 June 2011, the first joint conference of the European Compliance Academy and European QP Association was held in Bethesda, Maryland on European GMPs and the duties and responsibilities of the Qualified Persons according to the European regulations. Find out more.

In early October the FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development  in the fiscal year 2012 (October 2011- September 2012). Read more here.

The "Reflection paper on risk based quality management in clinical trials" recently published by the EMA contains a table (Annex 1) which presents the points to consider for the risk identification, examples of how to control them and eventually mitigation and/or acceptance solutions. This gives interesting insights into EMA's specific positions about risk control. Read more here.