GMP NEWS 2012

In June, the FDA has published a new Question and Answer Guidance for Endotoxin and Pyrogen Testing. It should reflect the current thinking of the agency on that topic. Read more here.

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.

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 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.

In its annual report 2011, the European Medicines Agency (EMA) reported about the number of inspections performed in that year. Go here to read more.

On June 12, 2012 the Medical Products Agency (Swedish Authority) published an introduction to the so called MEDDEV 2.1/6 Guidelines. Click here to read more.

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The FDA has published a Draft Guidance for Industry: Amendment to “Guidance for Industry: "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and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.