GMP News - Quality Assurance

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.

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.

So far, EU inspectorates did not publish any results of their inspections. This is changing now. Read more.

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.

The EU Commission published the responses to the public consultation of 4 revised chapters of the EU GMP Guide. 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.

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.