GMP NEWS 2012

APIs produced in third countries in Asia (like China and India) can only be imported into the EU if the regulatory authority of the exporting country will issue a written confirmation of GMP Compliance. The MHRA has published concerns that some APIs might not be available if the authority in the third country will not issue the necessary written confirmation. Please read more.

The detailed guidelines for the categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products are part of the "Variations Regulation" which is in force since the 1st January 2010. These guidelines which describe the categorisation of marketing authorisation variations are being significantly revised. Read more about the draft of the revised guidelines.

Warehouses and Distribution Facilities must be monitored very carefully. In order to assist the industry in meeting growing requirements, a new white paper and further documents have been published by Rx-360. Click here to read more.

In its latest press release, the Pharmaceutical Inspection Co-operation Scheme PIC/S highlighted the outcome of its last Committee Meeting. What are the main news? Read more.

The API Compliance Institute recently performed Third Party GMP Audits at two API manufacturing sites in Germany. The Audits were initiated by a group of Qualified Persons and QA Managers from different pharmaceutical companies who are using the respective APIs to manufacture their medicinal products. Please read more here.

We regularly analyse the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of the fiscal year 2012 (from 1st October 2011 to 15 March 2012). Read more.

The European Medicines Agency has published a set of questions and answers concerning the initial phases of the operation of the new pharmacovigilance legislation. Read more.

In the USP Pharmacopeial Forum, you can find a new general chapter on "Good Distribution Practices - Supply Chain Integrity". The main issue focuses on measures to be taken against counterfeit medicines ("Best Practices to combat Counterfeit Drugs and Medical Devices") and actions to avoid theft during transportation ("Good Trucking Security Practices"). Read more in the News.

At the end of 2011, the FDA published two draft guidance documents on clinical studies for medical devices. More about the content and the pilot programme started in this context can be found here.