Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters
An analysis of warning letters issued in the past fiscal year essentially shows the same pattern of frequently cited GMP violations. It also shows a noticeable increase in the GMP deficiencies relating to the qualification of suppliers and their certificates of analysis. Find out more.
Heraclitus once said: "There is nothing permanent except change". This statement is even true for the rather conservative GMP environment. What can we still expect for 2014? The answer to that question can be found in a work plan of EMA's GMP/GDP Inspectors Working Group.
Authority uses Margin of Interpretation regarding Qualification as QP
The Danish Health and Medicines Authority has published a document which shows that the EU has left enough leeway for the implementation of EU regulations. This would certainly be desirable for other Member States as well. Read more.
The European Medicines Agency (EMA) has published the Template for the Qualified Person's declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain - "The QP declaration template". Read more.
Important Judgement in the GMP World: EU Commission entitled to take far-reaching Decisions when GMP Deviations are found
A judgement of the EU Court of Justice (Sixth Chamber) from 10 April 2014 on the suspension of the marketing and the withdrawal of certain medicinal products batches has been published. The judgement highlights the importance of the decisions taken by the EU Commission. Read more about the judgement of the Court and the consequences for the GMP world.
Variations: How to submit Results of Confirmatory Stability Studies
The Co-ordination Group for Mutual Recognition and Decentralised Procedures has revised the Q/A-List for the Submission of Variations adding a question and answer regarding the submission of the results of confirmatory stability studies on production-scale batches. Read more.
Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Read more.
Compliance with the so called Food, Drug and Cosmetic Act is at top priority for the Department of Justice in the US. This statement has been given by Assistant Attorney General Stuart F. Delery in a conference on January 29, 2014 in Washington. Read more about the presentation.
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.