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[Dear Sir or Madam,

With this newsletter we would like to inform you about current regulatory affairs developments and trends with regard to Good Manufacturing Practices (GMP).

Your
ECA Team

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes. Find out more about Policy and Procedures regarding the Review of Grouped Product Quality Supplements.

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This course from 18-19 October 2016  in Vienna is intended to provide you with guidance on how to efficiently submit and process variations in the EU. Furthermore, you will learn how to manage changes in a multi customer situation using ASMFs or CEPs. Please see the programme for further information.

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On May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review. Read more on how agency staff in the Office of Pharmaceutical Quality (OPQ) should apply the recommendations in the ICH Q8, Q9 and Q 10 guidelines to CMC reviews.

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The United States Pharmacopeial Convention (USP) and the ECA Academy announce their cooperation in organising a joint conference entitled, “Lifecycle Approach to Analytical Procedures”. The conference will take place in Prague, Czech Republic, on 8th and 9th November 2016 at the Corinthia Hotel. Conference presentations, case studies and open discussions will help you to learn more about the lifecycle management of analytical procedures.Take further advantage if this forum to discuss USP’s new general chapter and Stimuli articles related to this topic. You will thus have the opportunity to give feedback and ask questions directly to USP’s Expert Panel Members on how to move forward with the transition to and implementation of the lifecycle approach. Please see the conference website for further information.

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• EMA publishes Reflection Paper on Off-Label Use for Comment
• EMA post-authorisation procedural advice for users of the centralised procedure
• EMA publishes QPPV Update

For further recent news please go here.

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Here you will find an updated overview of forthcoming education courses and conferences.

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GMP Search

Are you looking for GMP information on the web? Try www.gmp-search.com and search in the databases of ECA, FDA, EMA, ICH, PIC/S.

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Yours sincerely,

The European Compliance Academy

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