GMP NEWS 2010

EMA publishes Draft Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials

To provide a guidance for a harmonised quality documentation of biological Investigational medicinal products in clinical trials, the EMA published the draft of a new guideline. More details can be found here.

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Tracking & Tracing: EU decides on Amendments to Guidelines

The Committee on Internal Market and Consumer Protection of the European Parliament held a vote in March on numerous amendments to the draft directive from the EU Commission on the combating of counterfeit medicines. Read more.

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EMA revises its Process Validation Guidelines

In a draft paper, the European Medicines Agency (EMA) announced the reworking of their guidelines on process validation. Is this an attempt at European convergence with the FDA life cycle model? Read more here.

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New EMA Guidelines in Force for GMP Infringements by Manufacturers of Active Ingredients and CEP Revocation

The European Commission has adopted two documents which coordinate and concentrate the activities of the monitoring and licensing authorities in all EU Member States and the EDQM, in the event of serious GMP infringements by the manufacturers of active pharmaceutical ingredients and clinical test preparations. What are the consequences for the pharmaceutical manufacturer for example, of the withdrawal of a CEP from a supplier of active ingredients? Learn more here.

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Will there soon be obligatory GMP Regulations for Excipients?

Amendments to the draft guideline on combating counterfeit medicines have been proposed, stipulating obligatory GMP Regulations for excipients, as well as an official obligatory inspection of API manufacturers. Read more on this here.

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Germany's Preparations for the Traceability of Medicines

Germany is now starting a pilot project for the introduction of an identification/authentification system for the traceability of medicines. Read more.

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New EU Requirements in the Validation Process in the Form of a Revision of Section 1 of the EC GMP Guidelines?

In the draft revision of Section 1 (Quality Management System) of the EC GMP Guidelines, the topics of "process performance" and "state of control" also play a major role. These topics are also referred to in Step 3 of the process validation life cycle in the new FDA Guidance on Process Validation draft. Are the Europeans beginning to come into line with the FDA? Read more here.

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Survey: Revision of Chapter 1 of the EU GMP Guide

Survey: Recently a draft revision of Chapter 1 (Quality Management) of the EU-GMP Guide has been published with some comprehensive changes. We would like to get your opinion on the proposed changes. Here you find our survey.

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European Compliance Academy (ECA) established as Foundation

For the past ten years the European Compliance Academy (ECA) has been lead as a membership association. Now the organisation was transferred to a Foundation. To find out more about the foundation's purpose and structure please read here.

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Counterfeit Medicines: EFPIA Position Paper on the European Commission's Draft

In a position paper of October 2010, the EFPIA comments on the draft by the European Commission for fighting counterfeit medicines. The EFPIA calls for measures that go beyond those laid down in the Commission's draft. Details on the EFPIA position paper can be found here.

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New EMA Report on the 2008 Sampling and Test Programme

The examination of centrally permissible trade medicinal products, co-ordinated by the EMA, showed that more than half of the products still had open issues, triggered, amongst other things, by the analysis methods used. You can read more here.

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FDA Guidance for Submission of Documentation in Applications for Parametric Release

The FDA published the Guidance for Industry of "Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes", providing recommendations to applicants on information to include in support of parametric release for sterile products. More details can be found here.

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Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA)

Once every year the ECA Advisory Board convenes to review past activities and to determine activities throughout the year and beyond. To find out more about the developments and planned acitvties please read here.

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Interesting Pilot Project for safe Trade Routes introduced

The Secure Trace Consortium has introduced an interesting case study for a pilot project on presenting a safe supply chain. Additional details can be read here.

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Real Time Release Testing (Parametric Release) - EMA publishes new Guideline Draft open for Consultation

In February the EMA published the draft of a new Guideline for Real Time Release Testing (formerly Guideline on Parametric Release). The draft is open for comments until end of August 2010. More details can be found here.

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EMA Guideline for Stability Testing for Applications for Variations in revision

The European Medicines Agency EMA announces the revise of its "Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation". The time allowed for submitting comments and change requests is running. Learn more here.

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MHRA Consultation Procedure for Strengthening Secure Supply Chains

On 17 December 2009, the MHRA issued a public consultation procedure on the measures for strengthening the supply chains for medicinal products and for reducing the risks of counterfeit medicines. More can be found here.

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Deviations and CAPA most frequent observations in FDA inspections

As evidenced in the Warning Letter report issued for ECA, shortcoming in the handling of deviations and the implementation of CAPA systems are among the most frequent GMP deviations objected by the FDA. Read more.

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Microbiological Control of Herbal Drugs

With the European Pharmacopoeia Supplement 7 new microbiological methods for herbal drugs in were issued. Get the details here.

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European QP Association Releases Database "QPSHARE"

The European QP Association now released its new database "QPSHARE", allowing Qualified Persons to find potential partners for sharing audits. To read what's behind the new database please go here.

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