What is the current status concerning US 21 CFR Part 11 - Electronic Records, Electronic Signatures? 16 years after the release of the regulation and 10 years after a period of intensiv discussion you can read a short summary about the situation today. To read more see here.
The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human or veterinary marketing-authorisation or variation applications. Go here to read more.
Pharmacopoeial Forum 39 (2) contains a proposal for the revision of USP General Chapter <671>. Packaging systems have to demonstrate satisfactory container-closure integrity throughout the product's shelf life. It is proposed that this USP chapter will be revised to include a new permeation method for determining barrier protection for packaging systems. You will find more information in this news.
After a successful completed pilot phase, the ExcipactTM scheme will further expand as quality standard for GMP and GDP audits of manufacturers of pharmaceutical excipients. Read more here about the worldwide recognised audit scheme.
The proposed revision of Chapter <659> on Packaging and Storage Requirements shall help ensuring in the future that the definition of the "single-dose-containers" term is used correctly. In addition, the storage conditions for medicinal products have been defined completely. Read more here in the News.
In one of our last News, we reported about the DUNS numbers for the identification of pharmaceutical sites in Site Master Files. Last year, the FDA also started an initiative for the DUNS numbers. Read more.
The newly formed USP Elemental Impurites Implementation Advisory Group considers issues experienced by manufacturers of products especially affected by the elemental impurities standards. Read more about the output of the Group's last meeting.
The member states of the Southeast Asian association (ASEAN) have released the draft of a process validation guideline under the management of Singapore. The title is "Guidance for Quality by Design as an alternative Approach to Process Validation". The document is composed of 10 pages and is very much in line with... Read more here.
With the binding mention of a Site Master File in revised Chapter 4 of the EU GMP Guide, the document has become obligatory for all pharmaceutical companies. The EU Site Master File contains a few essential changes to the previously applicable PIC/S Guideline PE 008-3. In the new version for example under section ... read on.
Because of the number and complexity of medical devices, FDA's Center for Devices and Radiological Health (CDRH) has published many new guidelines. This makes it difficult to keep track of the current situation. In the following, we have compiled a selection of new FDA documents with regard to aspects of quality assurance and marketing authorisation ... Read more here.
In one of our News we reported about the end of the Global Harmonisation Task Force (GHTF) and presented the International Medical Device Regulators Forum (IMDRF) as successor organisation. For a start, the IMDRF has taken over the "old" GHTF guidelines and plans to develop them further successively where necessary. First efforts have now been made. Read more here ...