GMP News - Quality Assurance

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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