GMP NEWS 2009

Important Changes at EMEA

At the European Medicines Agency, a number of changes are going on. Here you can find an overview.

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Interesting Addition to the Q&As on ICH Q8, Q9 and Q10

The Quality Implementation Working Group on ICH has published new questions and answers on the ICH Q8, Q9 and Q10 guidelines. The new questions and the link to the answers can be found here.

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New FDA Guidance on Residual Solvents

Which recommendations does the FDA make on residual solvents and on the USP General Chapter <467> Residual Solvents? Our news gives the answer.

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Annexes to ICH Q4B Guideline Reach Next Step

At its meeting in October, the ICH Steering Committee brought some of the annexes to the ICH Q4B Guideline to the next step. Read here which guidelines are concerned.

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FDA adapts ICH Q8 (R2) Pharmaceutical Development as Guidance for Industry

The FDA has now also published the ICH Q8 document and its annex as Q8(R2) Pharmaceutical Development Guidance for Industry. Read more.

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New FDA Guidance on Impurities in APIs for Generics

FDA's Office of Generic Drugs revised the guidance for industry on impurities in active pharmaceutical ingredients in generics in June 2009. The guideline applies to active ingredients manufactured by chemical synthesis. Find more here.

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EMEA: New Application Form for Scientific Advice

With a letter of intent, interested persons can request scientific advice or procedural advice from EMEA. How this can be done now is described here.

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New White Paper by USP

More detailed information on a new white paper by USP titled "USP's Role in Setting Enforceable Quality Standards for Medicines" can be found here.

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Risk Posed by Counterfeit Personal Protective Equipment

According to the British Safety Industry Federation (BSIF), the health of British employees in the pharmaceutical industry is put at risk by counterfeit personal protective equipment (PPE). Read more.

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Modern Aspects of Equipment Qualification

The ASTM-document  (formerly  American Society for Testing and Materials) 2500-07 offers modern aspects regarding equipment qualification. A comparison shows differences to the classical way of DQ, IQ, OQ, PQ. Read more.

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EMEA Reflection Paper on the Extrapolation of Results from Clinical Studies published

The EMEA has published a Reflection Paper on the Extrapolation of Results from Clinical Studies conducted outside the EU to the EU-Population, which will come into effect on 01 May 2010. Read more.

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New Report on EU/EMEA and FDA Collaboration published

An implementation report on the 'Transatlantic Administrative Simplification Action Plan' has been published. This report is a result of the recent annual EU-EMEA/ FDA bilateral meeting in September, where the parties updated on the progress and status of the various projects. Read more.

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EMEA publishes Concept Paper on the Revision of the Guidance on Radiopharmaceuticals based Monoclonal Antibodies

EMEA has published a Concept Paper for the revision of the Note for Guidance on Pharmaceutical Based Monoclonal Antibodies (Eudralex 3AQ21a) from 1991. Read on here.

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The New Variations System - what is the current situation?

From 1 January 2010, the modified European system for handling variations to the terms of marketing authorisations comes into force. Read here to which types of marketing authorisation it applies.

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Method Transfer - USP Plans New General Chapter

The USP plans to dedicate a new general chapter to the subject of method transfer. Details of the corresponding stimuli article in the Pharmacopeial Forum can be found here.

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Three years of the EU Paediatric Regulation - what happened?

Since December 2006, the Regulation (EC) No 1901/2006 on Medicinal Products for Paediatric Use is in operation. And this regulation is mandatory for all pharmaceutical companies developing new products! Read more about the consequences for Pharmaceutical Development.

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FDA and EU Commission inform about Collaboration on Inspections

During the recent annual EU-EMEA/FDA bilateral meeting in September 2009, the parties updated on the progress of several projects, among others on the Collaboration on inspections. You will find more here

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Chapter 7 of EC GMP Guide to be revised

The chapter 7 of the EC GMP Guide regarding "Contract Manufacture and Analysis" is supposed to be revised. Get more information on the background - here.

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FDA publishes Guidance for Industry regarding Risk Evaluation and Mitigation

Die FDA has published the Guidance for Industry "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications". Read more here.

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Deputy Director Europe/US FDA will speak at QP Forum

Dr Janice M. Soreth, Deputy Director of the Europe/US FDA, Liaison to EMEA, located in London, U.K. has accepted the invitation of the QP Association to talk about the international programs of the FDA at the 4th QP Forum. Read more.

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