GMP News - Quality Assurance

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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12.01.11

New Best Practice Guides for the Submission and Processing of Variations published

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has published the latest version of its Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Read more.

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15.09.10

English Supervisory Authority MHRA Publishes Answers to FAQs on Risk Management

On its homepage, the English supervisory authority, MHRA, has published answers to frequently asked questions regarding the topic of quality risk management. Here you can read the answers.

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02.06.10

New Best Practice Guides for the Submission and Processing of Variations published

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human has updated the Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Find further information here.

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03.02.10

New CAPA Guidance Published

A concrete instruction for the implementation of the CAPA requirements cannot be found in the hitherto existing guidelines. Here, a newly proposed guidance by the GHTF can help. Read more here.

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