New Guide for Manufacturers of Stand Alone Software
On June 12, 2012 the Medical Products Agency (Swedish Authority) published an introduction to the so called MEDDEV 2.1/6 Guidelines. Click here to read more.
New ECA Working Group on Process Validation starts first Project
Many members of the European Compliance Academy (ECA) have recognised that there is a paradigm shift in Process Validation. Therefore, the new ECA Process Validation Working Group has defined its first project: A Good Practice Guide with the goal to provide assistance relative to the new Process Validation requirements and specifically to "what to do" and "how to do it". Read more.
Detailed Analysis of EMA's new Draft on Process Validation
We already informed about the availability of the new EMA Draft Guideline on Process Validation in one of our previous newsletters. Today we publish a detailed and comprehensive analysis of the document's content, the new requirements and the differences to the FDA Guide on Process Validation. Read more here.
EMA publishes Draft on the Process Validation Guideline
On 15 March 2012, the EMA published the long-awaited revision of the Process Validation Guideline. The finalised document will replace the current valid guideline entitled "Note for Guidance on Process Validation". Comments to the draft can be sent until 31 October 2012. Click here to read more.
Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 4
What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.
Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 3
What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.
Questions & Anwers on EU GMP Guideline Annex 11 "Computerised Systems" - chapters 1-2
What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.
When the FDA Process Validation Guidance mentioned the ASTM Standard E2500-07 in connection with modern approaches to qualification, interest was raised in this document. But the Standard is relatively short and not very specific. Now, interpretation is offered by an ISPE-Guide.
European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation
To find out what the European pharma industry thinks about the announced revision of the Process Validation Note for Guidance by the European Medicines Agency, the European Compliance Academy (ECA) together with Concept Heidelberg conducted a survey in September 2011. Read more here.
Technical Report - Assistance for Biotechnology Cleaning Validation
Since the Nineties, cleaning validation has been a topic in the area of GMP. Most guidelines cover the topic of cleaning validation only in a general way. The PDA's Technical Report No. 49 focuses on biotechnologically-manufactured products. This document consists of 68 pages, divided into 16 chapters. Read more here.
FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices
In May, the FDA published a Draft Guidance for Industry and FDA Staff entitled "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The document should … Read more here.
Why did FDA change their Guideline on Process Validation?
The 4th European GMP Conference took place in Heidelberg on 19/20 May 2011. During the Conference, Grace McNally, co-author of the new FDA Process Validation Guidance presented the reasons for the revision of this Guidance. Read more here.
New EMA Concept Paper on Process Validation of Biotechnology derived active Substances
On 19 May 2011, the EMA published a "Concept Paper on the need for a guideline on process validation of medicinal products containing biotechnology derived proteins of active substances". For the EMA, it was necessary to develop a Guideline, ... read on here.
The EMA (European Medicines Agency) has just published answers to questions on computerised systems under "Q&A: Good Manufacturing Practices (GMP)". Read more here.