GMP Inspections: Enhanced International Collaboration
The international exchange of information between authorities regarding GMP and serious inspection deficiencies is intensifying. Current examples are the FDA, BfArM and Swissmedic. Read more.
The last year was a difficult year for the FDA and the agency had to suffer from budget restrictions. Despite that, a lot of actions were ongoing. Here is a short summary of some selected activities.
Besides other publications, the European QP Association (EQPA) regularly issues questions and answers related to the role and responsibilities of the Qualified Person (QP). Now, after the last QP Forum, a new set of Q&As has been published. Read more.
The last year was an interesting year for those who have to have an eye on GMP regulations in the European Union. The EU GMP Guide is under constant revision. Here is an overview.
GMP for Radiopharmaceuticals - existing and expected Guidelines
Manufacturing of Radiopharmaceuticals includes some specific challenges. To provide additional guidance for these establishments, the PIC/S Committee's new Annex 3 to PE 010-3 is in the final stages for adoption. Read more here.
New USP Requirements for Pharmaceutical Packaging Materials and International Standards for the Measurement of Material Permeability Indexes
This year, the USP has already published many new requirements for pharmaceutical packaging systems in the Pharmacopeial Forum (PF). Some of the most important new proposals in the USP are summarized in this news. In addition you can read about recognised standards (ISO, ASTM, etc.) for the testing of permeability properties of packaging materials in this news.
ICH reviews future ICH topics and its Organisation
The results of the International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) meeting in Osaka, Japan have been published. Read more.
Revision of Annex 16: Results of Public Consultation
The responses to the public consultation on the revision of Annex 16 (Certification by a Qualified Person and Batch Release) have been published. Read more.
The European Medicine Agency (EMA) and the U.S. Food and Drug Agency (FDA) have published a joint question-and-answer document that provides further guidance on the quality-by-design concept. Read more.
Revised Annex 16: Comments of the European QP Association
In July this year, the European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". The European QP Association has provided a comprehensive summary as feedback to the proposal. Read more.
In a draft for a new General Chapter on "Plastic Materials", the USP has described the requirements set today on plastic packaging materials. It has also defined when plastic materials are suitable for use as packaging systems for medicinal products. Read more details about the publication in the Pharmacopeial Forum.
A huge benefit of smartphones and tablet PCs and apps is that you can access relevant information any time anywhere. Now you can also quickly and comfortably access information with regard to news and regulations in the GMP environment - and more. For that purpose the ECA Foundation took advantage of its longstanding experience to develop a free of charge smartphone and tablet PC WebApp. Find out more....