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GMP Inspections in Europe: Proven Strategies on How to Prepare

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1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


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More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


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Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


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Guide to preparing a company for compliance with Good Distribution Practice (GDP).


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A Guide to ICH Q10 Compliance


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News about GMP/cGMP

EMA: Work Plan 2012

The European Medicines Agency (EMA) released the work programme for 2012.


In 2012 the Agency will focus on the following topics:

  • Implementing new pharmacovigilance legislation
  • Implementing revised policies on handling conflicts on interests
  • Ethical and practical GCP (Good Clinical Practice) aspects of clinical trials
  • Progress of Agency interactions with healthcare professionals
  • Supply shortages of medicines caused by insufficient GMP compliance. EMAs Management Board initiated the discussion on a "Reflection paper on medicinal product supply shortages caused by manufacturing/GMP compliance problems".

EMA will publish a detailled work plan in January 2012. The "Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted outside of the EU/EEA and submitted in marketing authorisation applications to the EU regulatory authorities" will be presented to the Heads of Medicines Agencies for endorsement in February 2012 as a final step.


EMA/ Announcement


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