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3. Computer System Validation in the EU
a step-by-step guide to implementing a computer validation program


4. Risk Management
established methods of risk analysis
incl. ICH Q9


5. Preparing for the EU GMP Inspection
similarities - and subtle differences - between FDA and EU GMP inspections


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News about GMP/cGMP


EU revises regulation on outsourcing GMP activities. The GMP/GDP Inspectors Working Group proposes a revision of Chapter 7 "Contract Manufacture and Analysis" of the EU GMP Guide in order to upgrade guidance of outsourced GMP activities.


FDA extended the comment period for the proposed rule on Good Manufacturing Practices (GMPs) on combination products until February 5, 2010. This regulation will be interesting for every pharmaceutical company that delivers combination products.


Get an insight on the progress of collaboration between EMEA and FDA. The European Commission published recently the Implementation report 2009 on the "Transatlantic Administrative Simplification Action Plan".


The Food and Drug Administration (FDA) made public a new guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons. The guidance document, titled “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted for advanced viewing in the Federal Register on November 4, 2009.


Quality by Design (QbD) is a tool that is promoted through the recent ICH series Q8/Q9/Q10. We visited the most recent conferences and noticed a high interest in this topic. Now EMEA published a presentation of David Cockburn, held at the EMEA/Efpia QbD Application Workshop in London (Sept 29, 2009).


The U.S. Food and Drug Administration (FDA) has alerted healthcare professionals to changes in the United States Pharmacopeia (USP) monograph for heparin products, effective October 1, 2009. Heparin made using the tests and reference standards in the new USP monograph will become available in healthcare facilities on or after October 8, 2009.


David Cockburn, EMEA, announced last week at the PDA/EMEA Joint Conference in Berlin, that EMEA will work on changes of the EU-GMP-Guide (chapters & annexes).


Today the PDA/EMEA Joint Conference starts in Berlin, Germany. Maas & Peither is present at booth #18 at this important European Conference.

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