GMP News - Quality Assurance

09.03.11

EMA plans extensive Revision of the EU GMP Guide

At the beginning at this year, the European Medicines Agency (EMA) published the Work Plan for GMP/GDP (Good Manufacturing Practice/Good Distribution Practice) Inspectors Working Group. This document provides a good overview of the changes upcoming in the GMP/GDP environment - and it might come to a lot of changes. Read more here.

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03.03.11

Batch Record Review as GMP Deviation cited in FDA Warning Letters

As indicated by ECA's Warning Letter Report, Production Record Review deviations are (again) the most frequent GMP observations made by the FDA. Read more.

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24.02.11

EU-GMP Guide: New Introduction with Clarification of Status of Part III

As mentioned in a previous news, ICH Q9 and ICH Q10 will be adopted as Part III of the EU GMP Guide. In this regard, the EU Commission has revised the Introduction of the EU GMP Guide and clarified he status of the new Part III. Read more.

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22.02.11

EMA publishes final ‘Road map to 2015’

The European Medicines Agency has published its final 'Road map to 2015', setting out EMA's role as a public-health agency. Read more.

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22.02.11

New Pharmacovigilance Legislation adopted

Following the adoption by the Council and the European Parliament, a new Regulation and a new directive on pharmacovigilance were published in the Official Journal of the EU. Read more.

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17.02.11

In-depth analysis of the requirements on the new EU / PIC/S Site Master File

The new EU Site Master File document and the revision of the PIC/S document PE 008 on the creation of a Site Master File implies profound changes for the Site Master Files author. These changes affect every pharmaceutical manufacturer as a Site Master File is the basis for the inspection by a regulatory authority. You can find a detailed comparison between the new EU / PIC/S Site Master File document and the draft of the EC Commission here.

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17.02.11

FDA takes action against non-compliant manufacturer

On January 18, 2011 the US FDA obtained permanent injunction against Deltex Pharmaceuticals Inc. FDA has announced just recently that it will take immediate actions if manufacturers fail to comply with cGMP requirements. Read more here.

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17.02.11

FDA launches Basics for Industry Website

The U.S. FDA launched a new website called FDA Basics for Industry. On these web pages a lot of information is provided about the FDA, its responsibilities, expectations and regulatory processes. Read more.

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10.02.11

New version of EudraGMP allows access to information from all Member States

On 07. February 2011 the EMA announced a new version of the EudraGMP database. Click here to read more

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10.02.11

EMA publishes ICH Q9 and ICH Q 10 as Part 3 of the EU GMP Guide

The EMA announced the adoption of ICH Q9 and ICH Q10 as Part 3 of the EU GMP Guide. ICH Q9 was already published as Annex 20 but ICH Q 10 was not published as an Annex yet. Click here to read more.

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10.02.11

Growing Requirements on Process and Technology Transfers

Guidelines about Documentation on Transfers have been rather poor so far. Newly available GMP documents provide helpful information now. Read more.

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10.02.11

EMA publishes two documents on the QP Declaration concerning GMP Compliance of the API

The European Medicines Agency (EMA) has published two new draft documents for a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its supply chain called "The QP declaration template". Read more.

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10.02.11

PIC/S SMF Guide Updated with Quality Management System Requirements

The PIC/S Committee has adopted the revision of the Explanatory Notes for Industry on the Preparation of a Site Master File The main purposes of the revision were the simplification of the document and the implementation of requirements in relation with Quality Management Systems (QMS). Read more.

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27.01.11

EDQM strengthens international Collaboration

The EDQM is strengthening its collaboration by signing  Memorandums of Understanding (MoU) with the National Institute of Food and Drug Safety Evaluation (NIFDS), Korea Food and Drug Administration, and the Chinese National Institute of Food and Drug Control (NIFDC), respectively. Read more.

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19.01.11

New EU GMP Guide Chapter 4 on Documentation

The final Chapter 4 ("Documentation") of the EU Guideline to GMP has now been published and will come into operation on 30 June 2011. Some important changes were included. Get a summary here.

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