GMP NEWS 2009

API´s from Asia at Risk - Further CEP´s Suspended

The EDQM announces further suspensions of CEPs. The consequence for the manufacturers of medicinal product who use these CEPs is changing dramatically. You will find more here

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FDA publishes "The Enforcement Story" Report

Quite recently, the FDA published "The Enforcement Story" Report. The Enforcement Story describes FDA's accomplishments and enforcement-related activities in all product areas over which FDA has jurisdiction. The report contains interesting statistics, like the Enforcement Statistic from CDER (regulating drugs). You will find more here.

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Official Measures to Protect against Low-Quality APIs and Investigational Medicinal Products Co-ordinated throughout Europe

The EMEA published two documents that co-ordinate and focus the activities of the supervisory- and registration authorities of all EU member states and of the EDQM in the case of serious GMP deficiencies on the part of manufacturers of active ingredients and investigational medicinal products. Which consequences e.g. the suspension of an API manufacturer's CEP can have for a manufacturer of medicinal products can be read here.

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New FDA Draft Guidance on Postmarketing Studies and Clinical Trials

The new guidance will provide information about the requirements for postmarketing studies and clinical trials under section 505(o) of the Act. The guidance also describes the types of postmarketing studies and clinical trials. Read more.

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Danish Medicines Agency launches Project on Monitoring of GMP Compliance of APIs

The DMA has launched a project focusing on compliance with the rules by manufacturers of active pharmaceutical ingredients in 2009. In connection with the project, the DMA will spot check whether the rules are followed in connection with the manufacture and handling of API. You will find more here.

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EDQM issues Guidelines for OMCL Network

The EDQM issued documents for qualifying analytical equipment, and more recently also published documents for the validation of computerised systems. These guidelines are certainly not valid for the pharmaceutical industry. However, compared with own proceedings their contents are quite interesting. To learn where you can find these documents, read here.

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Public Consultation on Draft Revision 3 of detailed Guidance for the Request for Authorisation of a Clinical Trial

Public consultation on draft revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. Read more.

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FDA Publishes New Q-and-A on cGMP for Penicillin Drugs

As part of the "Questions and Answers on Good Manufacturing Practices Good Guidance Practices", FDA published a new section on penicillin drugs. Click here to read more.

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FDA adopts Pharmaceutical Development Guidance

The recoded Guidance for Industry Q8(R1) Pharmaceutical Development has now been adopted by the U.S. Food and Drug Administration FDA. Read more.

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FDA, TGA and EDQM establish Confidentiality Agreements

The three organisations will share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers. Here you will find more.

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Further CEPs from Chinese and Indian Manufacturers suspended or withdrawn

In addition to the previously announced suspension of five CEPs the EDQM announced further actions. Click here to read more.

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EMEA Draft Transparency Policy published for Consultation

The European Medicines Agency (EMEA) has released a draft transparency policy for public consultation. It sets out how the Agency intends to provide for greater clarity and openness in all areas of its operations. Read more.

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QPs implemented in new Canadian GMP Regulations?

The 2009 Edition of the Canadian GMP Guidelines (GUI-0001) introduces new aspects into the Canadian GMP regulations. When reading some of the new parts one might think that these GMPs are influenced by European GMPs. Read more.

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GMP for Excipients - New Decision of the EU Commission may lead to Misinterpretation

Following the publication of the report on an impact assessment study by an external contractor DG Enterprise and Industry has taken the decision not to continue with the preparation of a Commission Directive on GMP for certain excipients. But this may lead to a wrong interpretation. Here you will find more.

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Series of QP related Q&As published

The European QP Association has published a series of frequently asked questions and the respective answers on their website. Read more.

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New Guidance for Coordination of GCP Inspections published

A Guidance for coordination of GCP inspections and co-operation between GCP inspectors has been published in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures. Read more.

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Quo vadis GMP?

The USA have already made suggestions for updating the US-American GMP rules through their initiative "cGMP for the 21st Century". But what about Europe?

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EMEA: Guideline on Missing Data in Confirmatory Clinical Trials

CHMP has adopted the Guideline on Missing Data in Confirmatory Clinical Trials for release for consultation. Read more.

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FDA forms Transparency Task Force

The FDA is forming an internal Transparency Task Force to develop recommendations for making useful and understandable information about FDA activities. Read more.

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Current Ph.Eur. Requirements on Pharmaceutical Water

With the Supplement 6.3 to the European Pharmacopoeia, some changes with regard to water for pharmaceutical use came into force in 2009. Find more information here.

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