GMP NEWS 2012

Changes to the applicant part and the restricted part of an Active Substance Master Files may lead to misunderstandings - particularly if the API manufacturer and the marketing authorisation holder fail to communicate efficiently which possibly results in various versions and approval times. The Danish Medicines Agency has addressed the question and published it. Read more here.

The EMA guideline on quality of herbal medicinal products has been updated. Version 2 was published at the end of September. The document addresses the differences between medicinal products containing chemically defined APIs and herbal medicinal products and the resulting requirements and problems. Read more here.

On 1st February, 2012; the IPEC Federation announced the successful launch of EXCiPACT - its new, voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients. Please read more here.

Good Distribution Practice aspects have now found their way into the Pharmaceutical Inspection Co-Operation Scheme (PIC/S). Read more.

The EMA guideline on specifications for herbal substances, preparations and medicinal products has been updated. Version 02 was published at the end of September 2011 by the EMA. Further information and the link to the document can be found here in the News.

The latest revision of the Guideline on the Active Substance Master File Procedure mainly shows administrative changes supposed to harmonise the whole procedure and the communication between the ASMF holder and the Authorities. Read more here.

The Directive on the prevention of the entry of falsified medicinal products into the legal supply chain obliges the EU Commission to adopt the guidelines and principles of good manufacturing practice for APIs by means of a delegated act in form of a directive. In a first step, the Commission has published a concept paper for comment. Read more here.

On 15 December 2011, the draft of the revised monograph 5.1.2. "Biological Indicators in the Preparation of Sterile Products" (formerly "Biological Indicators of Sterilisation") was published for comment in the Pharmeuropa until 31 March 2012. More information here.

The use of not validated or inadequate analytical procedures and the lack of a GMP compliant qualification of analytical instruments - these are violations against basic GMP regulations in the analytical lab the FDA keeps on finding during inspections of API manufacturers. Read more about the analysis of API Warning Letters in the past fiscal year - here.