The ISPE has published a detailed document on the GMP-compliant handling of gases for pharmaceutical and biopharmaceutical production processes. The main focus of this Guide is on the development, the establishment, the implementation and the qualification of process gas systems. Read more here.
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.
ICH Publishes Additional Q8/Q9/Q10 Points to Consider
At its meeting in Seville in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics. Please find more about the new document which has been published on 6 December here.
Screening of Frequent Donors of Blood and Blood Components
The FDA published a Draft Guidance for Industry about the Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of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.
"Production Record Review" - The most frequently cited Paragraph in FDA Warning Letters
"Your firm has not thoroughly investigated the failure of a batch" - This is the most frequently cited criticism in the Warning Letters the US FDA issued to drug manufacturers in and outside the US in the Fiscal Year 2011. To get more information about the first results of the Warning Letters analysis that is annually published by Concept Heidelberg, please go here.
FDA wants to streamline the Classification of Blood and Plasma Recalls
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.
The ECA provides the FDA Warning Letters Analysis on a regular basis. This news describes the development of the 2002 to 2011 Warning Letters Top Five list with regard to medical devices. The number of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) is…. read more.
First ECA/EQPA Conference in the U.S. a great Success
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.
FDA publishes List of Guidance Documents for Medical Devices
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.
FDA strives for more Transparency regarding GMP Compliance and Enforcement Data
The US Food and Drug Administration (FDA) has issued a report in which it proposes to make Compliance and Enforcement Information more accessible and user-friendly. The proposals are part of FDA's current efforts to make its operation and decision making more transparent. Read more.
EMA Reflection Paper provides Concrete Information about Risk based Quality Management
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.