GMP NEWS 2009

New Guidance: Formal Meetings Between the FDA and Sponsors or Applicants

The FDA has published a new guidance providing recommendations to industry on formal meetings between the FDA and sponsors or applicants. The guidance supersedes the "Guidance for Industry Formal Meetings With Sponsors and Applicants for PDUFA Products" published in February 2000. Read more.

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EMEA publishes Question/Answers on Endotoxin Testing and Sterility Testing

On 19 May 2009 EMEA published 2 new Question and Answers (Q/As) on endotoxin testing and sterility testing at the end of the shelf-life. You will find more here.

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EMEA issues new Draft regarding NIRS

The new EMEA draft regarding NIRS covers development, calibration, validation and the maintenance of NIRS methods und outlines, what data need to be submitted to the authorities. Read more here.

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Commission Directive regarding Advanced Therapy Medicinal Products approved

On 2 March 2009, the Member States have approved the new Commission Directive amending regarding advanced therapy medicinal products, Annex I to Directive 2001/83/EC. The draft Directive was put to vote at a meeting of the Standing Committee on Medicinal Products for Human Use. Find more here.

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University of Mannheim initiates Survey on Risks in the Supply Chain

As part of the "global tracer" project the Mannheim Business School at the University of Mannheim conducts a survey on risks in the supply chain of companies in the pharmaceutical and biotech industries. Get the details here.

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Pharmaceutical Development: New Challenges through ICH Q8 Annex

The ICH Q8 Annex will also become effective in Europe in June 2009. Read here what the authorities expect in terms of an intensified, QbD-oriented development approach. FInd more information here.

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FDA requests a 19 Percent Budget Raise

The FDA has requested a budget of 3.2 billion US $ for the fiscal year 2010. This is a 19 percent raise over the fiscal year 2009. Read more here.

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Overview of New and Withdrawn FDA Guidances

The FDA has published its list of new and withdrawn guidance documents for the first 4 months 2009. Read more here.

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EMEA publishes new Draft of "Guideline on Plasma derived Medicinal Products"

Improvements in protein purification and molecular separation technology and the large number of donations which are pooled made it necessary to revise the "Guideline on Plasma Derived Medicinal Products" by the European Medicines Agency. Read more here.

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EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing

The European Medicinces Agency (EMEA) has published a new Guideline on Replacement of the Rabbit Pyrogen Testing by an Alternative Testing for Plasma derived Medicinal Products to provide a possibility to cover detection gaps like fever inducing cytokines. Read more here.

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ICH Publishes Questions-and-Answers Document on Q8, Q9 and Q10

In order to facilitate the implementation of the Q8/Q9/Q10 Guidelines, the ICH Experts have developed a series of Q&As. This document was finalised on March 11, 2009 and approved by the ICH Steering Committee under Step 4 on April 15, 2009.  You will find more information here.

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Two Recent FDA Warning Letters to Chinese API Manufacturers Reveal Enormous Risks in the Procurement of Starting Materials

In their effort to shed light on the origins of contaminated heparin, the FDA inspected two Chinese manufacturers of active pharmaceutical ingredients. This resulted in two warning letters with alarming conclusions. Find the details here.

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EMEA publishes new Q and As on PAT

One of the most useful resources with regard to current GMP interpretation in Europe are the Questions and Answers published by the European Medicines Agency (EMEA). To find out more about recently issued Q&As on PAT, read on here.

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EDQM suspends five CEPs after inspecting Chinese Manufacturer Sites

The European Directorate for the Quality of Medicines and HealthCare (EDQM) announced the suspension of five CEPs on their webpage. All of the CEP owners are Chinese companies. Click here to read more.

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New EMEA Concept Paper on the Revision of the EU Guideline Good Distribution Practices (GDP)

The European Medicines Agency (EMEA) has made plans for adaptations to the Good Distribution Practice Guideline (94/C 63/03). Read more about the concept.

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EDQM Guideline on Suspension or Cancellation of a CEP

The EDQM explains its policy on the suspension or withdrawal of a certification of suitability in a new document. You will find more here.

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Updated Categories of Variations in the New Variations Regulation

The two new consultation papers published by EMEA as part of the new variations regulation describe the details of the various categories of variations as well as the handling of the procedures defined in the regulation. Read more here.

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Batch Record Review in the Focus of Inspection Authorities

After 2007, violations of CFR 211.192 (Production Record Review) were again the most frequent citations in Warning Letters in the fiscal year 2008. Read more.

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Validation Findings in FDA Warning Letters 2008

The topic Validation is not listed as a paragraph in the 21 CFR 210/211. Therefore the ECA´s Warning Letters Report 2008 didn't cover this subject. In the following validation findings are analysed for the fiscal year 2008. Read more.

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EMEA Plans on Revising EC GMP Guide to Implement ICH Q10

On 11 March 2009 the EMEA issued a so-called concept paper. In this paper the authority explains the problems in impementing the ICH Guideline Q10 "Pharmaceutical Quality System" in European legislation und thus proposes a revision of the EC GMP Guide. Read on here.

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