The US FDA adopted the "ICH Guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests - general chapter". 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 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.
On behalf of the European 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 fiscal year 2013 (from 1st October 2012 to 31 September 2013). Read more here.
Particles in medicinal products for parenteral use as well as the 100% inspection on particles stay in the focus of the US American authorities. There are some upcoming changes in the USP with respect to particle inspection, which you can find here.
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.
When will the new single EU numbering system for ASMFs be obligatory? Can an ASMF holder have more than one ASMF for one active substance? Those questions and other ones have been answered in a new Q&A document on the ASMF procedure published by the CMDh at the end of September. Read more here.
Because of ongoing globalisation and outsourcing activities, more and more audits have to be performed. A possibility in saving resources is sharing an audit. Read more about a service offered by the European QP Association.
With the proposal of <1664> Assessment of Drug Product Leachables associated with Pharmaceutical Packaging/Delivery Systems, the USP continued their activities regarding the suitability of packaging materials. Read more.
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....
What data on the validation of bioanalytical methods does the FDA expect in an authorisation dossier? Information on this question is provided by a new draft guidance for industry. Read more on the content of this document.
In a new Guideline, the FDA laid down concrete provisions regarding how printed packaging (labels, cartons, etc.) should be designed to ensure the readability of the most important information. The purpose is to enhance the safe use of medicinal products and to reduce the number of medication errors. Read more in the News.
A new FDA document is supposed to provide a consistent approach to the handling of submissions of investigational new drug applications (INDs) within the Center for Drug Evaluation and Research (CDER). This concerns the processes within the FDA as well as the communication with the applicant. More information is available in this News.
The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) announce the availability of two draft chapters on the interpretation of the new EU GDP Guideline. Please find more here.
The use of a black triangle-shaped warning symbol will be required as of January 2014 for drugs containing new APIs and biological products (including biosimilars) to enhance medicinal products safety. More information can be found in the News.