GMP NEWS 2008

European Commission Publishes Package of Measures against Counterfeit Medicines

On 11 December 2008, the European Commission published a press release as well as three legislative proposals intended to improve the supply of safe, innovative and accessible medicinal products in Europe. Get more details here.

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ISO 9001 - New Version Published

The international quality management standard ISO 9001 has been revised. More details on the changes can be found here.

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Center for Biologics Evaluation and Research (CBER) - FY 2007 Annual Report

In October the Center for Biologics Evaluation and Research (CBER) published its annual report for fiscal year 2007 with overviews on the activities of the different CBER competency departments. Get more details here.

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Procedures and Guidances for GCP Inspections

The various supervisory authorities have created and published documents for their inspectors, which also give valuable advice to the GCP auditors of the sponsor. On the other hand, they help those who are subject to audits or inspections to prepare for the examination. Here you can find an overview.

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EMEA Plans Amended Guideline on Parametric Release

On 26 November 2008, the EMEA published a Concept Paper on the Revision of the Guideline on Parametric Release. The revision is carried out in order to take account of the approaches from the ICH Guidelines Q8, Q9 and Q10. Read on here.

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

As every year, the ECA Advisory Board discussed the organisation’s status and future activities during its annual meeting. This year the meeting was held in Assmannshausen near Frankfurt and concentrated to a large part on the results of the first member survey conducted in the first half of the year. Find out more here.

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FDA reported Fatalities following Blood Collection and Transfusion

On this website, the FDA shows the data of the Annual Fatalities Report after Blood Collection and Transfusion, with detailed data concerning the causes like Transfusion Related Acute Lung Injury (TRALI), Hemolytic Transfusion Reactions (HTR) and Microbial Infection. Read more.

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FDA Pushing Ahead with Quality by Design (QbD) Developments

With the goal of pushing ahead with the QbD initiative, the US-American health authority FDA made a contract with the National Institute for Pharmaceutical Technology (NIPTE) for 1.19 million US$. Read more here.

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FDA`s New Process Validation Guidance - A detailed analysis

The industry has been waiting for the American Food & Drug Administration (FDA) to publish its revision of the Process Validation Guideline. Now the Agency has made its current thinking regarding process validation public. A summary of the new draft can be found here.

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Implementation of the Paediatric Regulation: new Commission Guideline

Implementation of the Paediatric Regulation: Commission guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies. Read more.

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EMEA publishes Drafts regarding the ICH Topic Q4B

Within the <Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions> the Q4B Expert Working Group of the EMEA published the drafts of the new Annex 4A, 4B and 4C in June. Read on here.

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FDA Publishes New Question and Answer Section on cGMP Compliance

The FDA published 4 new questions and answers in the section "Production and Process Control". Two answers inform about how to contact the PAT Team. The other two questions deal with the acceptance of ISO 14644 in the field of aseptic processing and the implementation of PAT. You will find more here.

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Revised Annex 7 to the EC GMP Guide: Manufacture of Herbal Medicinal Products

The revision had become necessary in order to adapt the general GMP regulations for active pharmaceutical ingredients (Part II) specifically to the manufacture of herbal medicinal products. Find the details here.

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MHRA publishes Good Pharmacovigilance Practice Guide

The MHRA has announced the imminent publication of the ‘Good Pharmacovigilance Practice Guide’ which is intended to complement currently available legislation and guidance. Read more.

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New Questions and Answers published by EMEA

Two new questions and answers have been added to the list of frequently asked GMP related questions. Another Question and Answer has been prepared on active substances whose primary industrial use is not as a pharmaceutical active substance (and the producers of these substances may not be aiming to meet the specific GMP requirements of their pharmaceutical customers). Read more.

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New FDA Approach for Feedback on Applications for a Marketing Authorisation (NDA/ ANDA)

The former system with the 3 different kinds of feedback possibilities from the FDA to a submitted application for a marketing authorisation (NDA/ANDA) was not always consistent. The system has now been updated: Read here more.

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Variations Regulation: ENVI Committee of European Parliament adopts Draft Report on Variations

The competent committee of the European Parliament (Environment, Public Health and Food Safety) adopted the proposed draft regarding variations to the terms of marketing authorisations for medicinal products with the pertaining amendments on 9 September. Two of the changes are quite interesting.  Find out more.

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News from the GCP Inspectors Working Group

The revised Work Plan For GCP Inspectors Working Group for 2008 and a Question and Answer on records of study subject data relating to clinical trials have been published on the EMEA Inspections Section. Read more here.

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EDQM optimises Evaluation Process of CEP Applications

In order to ensure that the official timelines are met, EDQM has decided to apply the procedure for managing the Certification Scheme more strictly. Find more information here.

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Change of Consultation Period for the Revision of Annex 13

The European Commission has extended the consultation period for the revision of Annex 13 of the GMP Guide until 31 January 2009 . Read more.

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