GMP NEWS 2013

The FDA has published a new Draft Guidance on "Limiting an inspection" for comment.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.

As of 4 August 2013 on, a new form for variation applications has to be used. Read more here about what the marketing authorisation holder has to take into consideration.

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.

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.

Many manufacturing plants face problems during tableting. The most common problems are sticking, lamination or weight variations. But what are the reasons for this? Read more.

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.

The European Medicines Agency EMA has published a Concept Paper underlining all aspects of manufacture that are important for both applicant and regulator. Read more.

The Questions and Answers of the EMA on procedural questions for centralised marketing authorisations have been recently updated and completed with 2 new questions/answers. More details here.