The Qualified Person (QP) often reviews the batch documentation personally prior to certification of the batch. But is the QP obliged to do so? Read here, why the QP is not.
Frequently we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). For that reason you can now find explanations to the three most important documents in this news.
New FDA Guidance on the Finalization of several FDA Draft Guidances
On 7. August 2013 the US FDA published a notice in the federal register entitled: Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances. Read more.
WHO revises GMP Guide regarding the Principles of GMP
In July the WHO has published a revised version of their Guideline "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" for comment. Read on.
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 European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Read more about the envisaged changes.
Globalisation of Manufacturing and Distributing Medicinal Products Causing Troubles according to the FDA
On the FDA website, you can find the slides of a presentation made by Robert Sklamberg, Director of CDER's Office of Compliance in May 2013. The topic deals with the challenges presented by globalisation of manufacturing and distributing. Read more here.
The ACAA between the EU and Israel entered into force on 19 January 2013. It is a framework agreement that recognizes Israeli industrial standards as equivalent to European standards and is similar to a Mutual Recognition Agreement (MRAs). Read more.
The U.S. Food and Drug Administration FDA has published the long awaited draft Guidance for Industry "Contract Manufacturing Arrangements for Drugs: Quality Agreements". Read more.
The European Medicines Agency has published a new set of Question and Answers on their website. A whole set of Q&As is dealing with API supplies and the auditing of the respective sites. Read more.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has published a Contingency Plan for exceptional waivers intended to apply where it is necessary to ensure the availability of medicinal products. Read more.
In a globalised world, it is interesting to consider pharmaceutical markets outside the classical regions Europe, USA and Japan like, for example, South America. Read more.
Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5
On behalf of the Eurpean Compliance Academy the team of Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of fiscal year 2013 (from 1st October 2012 to 31 March 2013). The number of Warning Letters (107) issued by the Center for Devices and Radiological Health (CDRH) and the respective "District Offices" in the first half of fiscal year 2013 is considerably higher. Read more here.