In order to change the "old" Good Distribution Practices Guideline from 1994 the European Commission published a proposal for a new version on 15 July 2011. The EU Commission received a large number of comments from stakeholders. But what are the next steps? Please find more in our GMP News.
The ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&G) has been available since 2001. Now, an ISPE mapping document explains the relationship between the ISPE Baseline Guide Volume 5 and the new ISPE Guide "Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment" (FSE Guide). The mapping document also presents an ISPE Guide (Applied Risk Management Guide) which has the function of a "bridge" between these two documents. Read this news to get an overview of this "Mapping-Document for ISPE Specification and Verification Guides" that explains the relationship of different ISPE Guides with regard to qualification.
On 31 January 2013 the new Annex 2 of the EU GMP Guide becomes effective. In comparison to the version valid so far the new version has clearly increased in terms of volume and content. This is also due to the fact that it now takes into consideration the development of new types of biological medicines. Read more.
The intention of the EU Commission to integrate GMP regulations for APIs into the existing Directive 2003/94/EC via a delegated act faces rejection from companies and industry associations. Their comments on the respective concept paper from the EU Commission have been recently published. Read more here.
The European Medicines Agency has today agreed on a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis. Read more.
In our news from 4 July 2012 we reported on a publication on the results of inspections carried out by the MHRA (Medicines and Healthcare Products Regulatory Agency, MHRA). It is worthwhile to take a look at this publication also beyond the actual top ten list of deficiencies, since there are relatively few publications on GMP deficiencies by European authorities. The following observations focus on the topics process validation/equipment qualification/calibration.
Japaneses GMP requirements are defined by the "Pharmaceuticals and Medical Devices Agency - PMDA". Now, a tentative translation of the requirements on Computerised systems into English is available. Read more.
The European Commission has published the final version of the revised Chapter 1 of the EU GMP Guide, which will now be called "Pharmaceutical Quality System". It includes comprehensive changes. Read more.
The FDA has put into effect the ICH document with points to consider covering topics relevant to ICH Q8, Q9 and Q 10 in July 2012. This guideline is intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment, and inspection related to QbD-applications filed for marketing authorisations. Get the complete news.
In July 2012, the FDA announced via its Center for Devices and Radiological Health (CDRH) - which is also responsible for medical devices - the publication of requirements on harmonised designation of medical devices (Unique Device Identification System, UDI system). The Congress had already enacted a law in 2007. A draft is now available.
The new regulation of the Chinese State Food and Drug Administration defines a strengthened supervision of the manufacture of pharmaceutical excipients. Read here who will be affected by these new provisions.
After a long transitional period the Norm IEC 60601-1 with regard to security requirements and ergonomical demands for medical devices has become effective as Version 3 on 1 June 2012. Specifically interesting in this new version is the topic risk management. Read more.
Following the PIP scandal the EU currently deals more intensively with the planned revision of medical devices regulation. In a resolution the European Parliament has now proposed various measures to eliminate the "system's malfunctions on a European and a national level". Read on.