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.
USP Elemental Impurities Implementation Advisory Group - Meeting Summary
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.
Updated Procedure for the Renewal and Revision of CEPs!
As of 1st September 2013, an updated procedure for the renewal and revision of CEPs will apply. By the end of July, the EDQM had already published the respective revised Guidelines and application forms. Read more here about the coming expectations for CEP holders.
New EMA Guideline on Starting Materials from Biological Medicinal Products
A new EMA Guideline clarifies the most important questions about the definition of starting materials and intermediates of biological medicinal products as well as the quality documentation of the marketing authorisation dossier. More details here.
Draft Guideline ICH Q3D for Elemental Impurities published!
The ICH Q3D Guideline on Elemental Impurities has just been published. This Guideline will have a major impact on both the pharmaceutical and the API industry and companies now have to make efforts to be prepared for the new provisions of the guideline. More details here.
Denying, Delaying, And Refusing: How to Fail a FDA Inspection
The FDA has published a new Draft Guidance on "Limiting an inspection" for comment. The document provides a detailed presentation of behaviours during a FDA inspection which may be seen as obstruction by the FDA inspectors. More details here.
Written Confirmation: A Questions & Answer Document of the Danish Authority provides further Clarifications
The regulation regarding the imports of APIs into the EU which must be accompanied by a Written Confirmation has been effective since 2 July 2013 and keeps on raising new specific questions. The DHMA (Danish Health and Medicines Authority) has recently published a Questions & Answers document. Read more here.
How do I apply for a CEP? An updated guideline of the EDQM provides information
In an updated guideline for CEP applicants, the EDQM describes in what form they have to submit the documents to apply for a certificate of suitability. Learn more about this guideline and the application procedure here.
Risk-based Approach to APIs Consignments without Written Confirmation
API consignments without Written Confirmation which are trapped on the EU external borders and held under quarantine - how to handle this situation? A guideline of the HMA provides the answer. Read more here.