Since the PIP scandal, the EU has been working on strengthening the planned revision of the Medical Devices Guidelines. The European Parliament has proposed different measures in a resolution to get rid of the "malfunctioning of the system at European and national levels". Read more here.
The annual Rapid Microbiological Methods Conference of the ECA will take place on 11. and 12 December in Munich, Germany. Many speakers from authorities, industry and method development already confirmed their participation. Get the details.
In the March Edition of the American Pharmaceutical Review, Dr Michael Miller published a case study of a New Growth-based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and provides an Estimation of Viable Cell Count. Read more.
The EDQM has published a document about the most frequent deficiencies found in application dossiers for CEPs and gives recommendations on how to avoid such errors. Read more here about these "Top Ten Deficiencies".
The "Guideline on Active Substance Master File Procedure" describes the requirements for marketing authorisation holders regarding the ASMF procedure. The revision of this guideline which has been published recently will come into force at the beginning of this year's 4th quarter. Read more here about the coming changes for API manufacturers and the pharmaceutical industry.
The API Compliance Institute co-ordinates so called Third Party Audits. On behalf of one or several QPs, GMP audits are performed at API manufacturers. Some audits are made available for companies who were not involved in the initial sponsoring of the audit. These GMP audits are called shared audits. Please find more information about the latest Shared Audit.
For some time now, the FDA has been strengthening its inspection activities at API facilities not only in the Far East but also in Europe. The analysis of the 8 Warning Letters which have already been issued for fiscal year 2012 confirms this trend. Read more here about what FDA investigators mostly have to object to in European facilities.
The EMA has recently extended its Questions and Answers collection with three statements regarding the setting of drug substance specifications for potentially genotoxic, metallic impurities, and solvent residues. More details here.
In response to growing product recalls due to glass particles found in injectable medications, the USP will present the new Chapter <1660> in the July-August edition of the Pharmacopeial Forum (PF). This new chapter describes methods to test the inner surface of glass containers. Read more here.
The FDA has published a Draft Guidance for Industry: Amendment to “Guidance for Industry: "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”. More details can be found here.