GMP NEWS 2013

FDA Publishes Guidance on Clinical Trials

At the beginning of August, the FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011 in which a few comments … read more here.

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EU-GMP Guide: final Chapter 2 on Personnel published

The European Commission has published the revised Chapter 2 on Personnel, which will come into operation on 16 February 2014. The basic principles of the chapter have been unchanged; however a few new approaches have been added. Read more.

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Frequently asked GMP question: How should active substance auditors be qualified?

From time to time we receive "GMP questions" from ECA Members.  Please read the anwer to this question in our GMP News

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Changes in the EDQM CEP Database

The EDQM maintains a database that contains the relevant information about the Certificates of Suitability (CEP). Read more about the changes in the CEP database.

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EFPIA selects Microsoft Cloud Platform for the European Verification System against counterfeit Medicines

After a selection process over 15 months and out of 20 vendors the EFPIA and the European Medicines Verification System (EMVS) has chosen the software company Solidsoft with the cloud-based Windows Azure from Microsoft. You will find everything else in this news.

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EMA Guideline Guideline on the use of bovine serum in the manufacture of human biological medicinal products

The EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products will come into effect at the end of 2013. Read more here.

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FDA publishes Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility

Computer validation will be an important topic for blood establishments too. The US FDA published a guideline on that topic in March 2013. Read more here.

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FDA Scientists link transfused UVB irradiated platelets with acute lung injury

Scientists at the U.S. Food and Drug Administration (FDA) have reported that studies performed in animals provide a proof of a concept that transfused UV-light damaged PLTs can mediate lung injury. Read more.

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Batch Record: who needs to review?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of the batch. But is the QP obliged to do so? Read here, why the QP is not.

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Interesting APIC/CEFIC Guideline for the Qualification of Contract Laboratories

The APIC has published a guideline for the management and the qualification of contract laboratories. The guideline is supplemented by detailed checklists and questionnaires, which are very useful for practice. For more information read this news.

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WHO revises Guideline for Maximum Hold Times

In July the WHO has released a revised draft of its new guideline for determining the maximum hold time. Read more.

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FDA Inspection Reports: What is What

Frequently we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). For that reason you can now find explanations to the three most important documents in this news.

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New FDA Guidance on the Finalization of several FDA Draft Guidances

On 7. August 2013 the US FDA published a notice in the federal register entitled: Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances. Read more.

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Frequently asked GMP Question: How to reduce testing and comply with GMP?

Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. But how to reduce testing and comply with GMP? Read more in our GMP News

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EFPIA - What Medicinal Product Manufacturers need to know about the European Verification System EMVS

What provisions does a pharmaceutical company have to make today to meet the future requirements of the EU directive against counterfeit medicines? The EFPIA "guidance for manufacturers" shows what is required and what is necessary so that in future the distribution channels for medicines are safe. Read the details in this news.

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WHO revises GMP Guide regarding the Principles of GMP

In July the WHO has published a revised version of their Guideline "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" for comment. Read on.

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PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US

Under certain circumstances unapproved bulk or finished products can be imported in the United States before granting the marketing authorisation. For this purpose the FDA recently described a new standardised approach in a draft of a "Guidance for Industry". What pharmaceutical companies have to consider prior to launching their products in the United States you can read here.

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European Commission publishes Recommendations for the Labelling of Medical Devices

There are no specific provisions regarding the traceability of medical devices in the European regulatory framework for medical devices. That’s why the EU Commission has now published "Recommendations on a common framework for a system of unique product marking for medical devices". Read more.

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What's new from the FDA regarding Medical Devices?

In hardly any other area the FDA ‘s Center for devices and radiological health publishes so many guidelines as in the area of medical devices. Find out what has been achieved in the last few months.

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Updated Procedure for the Renewal and Revision of CEPs!

As of 1st September 2013, an updated procedure for the renewal and revision of CEPs will apply. By the end of July, the EDQM had already published the respective revised Guidelines and application forms. Read more here about the coming expectations for CEP holders.

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