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.
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.
The FDA has published a new Draft Guidance on "Limiting an inspection" for comment.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.
In practice, the conversion to PDE/ADE-based limits (e.g. in cleaning validation) leads to many issues. The new scientifically-based approach requires toxicological/ pharmacological data i.e. to precisely determine the necessary correction factors. The following documents and databases may be helpful.
The USP divides the pharmaceutical dosage forms into 5 groups and wants to elaborate new General Chapters to depict the quality and performance requirements specific to each of these 5 dosage forms. The current status of implementation is addressed in an interesting article of the Pharmacopeial Forum. Read more.
On 27 June 2013, the EU Commission updated the so-called "Compilation of Community Procedures on Inspections and Exchange of Information". This document serves the exchange of information and the harmonisation of inspection standards between all the EU Member States. Read more details here.
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.
In its final Guideline on Monitoring Crude Heparin for Quality, the FDA sets the FDA quality standards to be considered when using crude heparin. In particular, it must be ensured that heparin isn't contaminated with OSCS and that the correct species origin is used for the extraction of crude heparin. Read more here in the News.
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.
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.