Recently, the USP published frequently asked questions relative to different General Chapters, amongst others to Chapter <62> Microbial Enumeration of Nonsterile Products: Tests for Specified Microorganisms. More details can be found here.
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.
Scientists at the U.S. Food and Drug Administration (FDA) have confirmed that plasma specimens are well-suited for detecting the genetic material of hepatitis C virus (HCV) in potential blood donors who are infected with the virus. 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.
In the light of recent events, the EMA has updated its "Compilation of Community Procedures on Inspections and Exchange of Information". Some documents concerning GDP have been added to this compilation of procedures which is not only interesting for inspectors. For more information read here.
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.
At the end of May, the EMA published a draft of the biosimilar guideline from 2006 for comment. This guideline describes the requirements on quality evidence for biosimilar medicinal products. Read more here about the updated instructions.
On 5 June 2012, the FDA has begun a "voluntary program" for medical devices audits entitled "Medical Devices ISO 13485:2003 Voluntary Audit Report Submission Pilot Program" - based on ISO 13485:2003. The purpose is to extend FDA's inspection intervals. 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 new IMPD Guideline - which has been recently published by the EMA - describes the requirements for quality documentation concerning biotechnological investigational medicinal products and provides - among other things - statements about shelf-life extension. Get more here.
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.
According to a notice from the EDQM with regard to a meeting of the Pharmacopoeial Discussion Group (PDG) 28 of the 35 General Chapters and 41 of the 61 monographs on excipients are currently harmonised. You will find more about the latest status relative to the PDG working group in this news. The strategies for an efficient management of the different pharmacopoeial requirements (EP, USP, JP) are also the topic at an international Pharmacopoeia conference in Prague.