GMP News - Quality Assurance

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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08.12.10

EMA Concept Paper on Storage Conditions during Transport

The European Medicines Agency (EMA) has published a concept paper on storage conditions during transport. The goal is to create new Good Distribution Practice (GDP) and GMP guidance. Read more

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08.12.10

Concept Paper: Quality Management Challenges in Pharmaceutical Industry

A recently introduced quality management model discusses new processes and their compliance with international developments and governmental expectations as e.g. expressed in the ICH Q10 guideline. Read more.

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01.12.10

Will there soon be a shortage of QPs?

The European QP Association (EQPA), the interest group of European QPs, has published a press release criticising the different interpretation of the applicable Directive in the various Member States. Read more.

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25.11.10

FDA becomes official member of PIC/S

At its last meeting in Malaysia, the PIC/S Committee officially invited the FDA (Food and Drug Administration) to join the Pharmaceutical Inspection Co-operation Scheme as from 1 January 2011. Read more here.

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17.11.10

"Outsourced Activities" - Revision of Chapter 7 of the EU GMP Guide

Chapter 7 of the EU GMP Guide entitled "Contract Manufacture and Analysis" has been revised to a large extent and its title has been changed to "Outsourcing Activities". The draft revision was published on 9 November 2010 with the deadline for public consultation on 28 February 2011. Read about what has changed besides the title of the chapter here.

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13.10.10

GMP and Quality Regulation in Japan

Most people are not aware that the Japanese Pharmaceuticals and Medical Device Agency's (PMDA) website is well designed and provides a good overview about the requirements in English language. Click here to read more.

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06.10.10

Variations Regulation: how to classify special Changes

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h) has updated their Q&As on Variations according to Commission Regulation (EC) 1234/2008. A question was added on the classification of special changes. Read more.

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06.10.10

Will FDA join PIC/S this Year?

Probably before the end of the year, the FDA will become a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Now does this mean that the FDA will not perform any more inspections in PIC/S member states? Read more.

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29.09.10

ICH Q10: What European Inspectorates will look for

The MHRA has published a set of FAQs regarding Quality Risk Management (QRM). These questions and the respective answers give a good overview and indication on how EU Inspectorates will be inspecting and enforcing QRM elements with regard of the ICH guidelines Q8, Q9 and Q10. Read more.

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23.09.10

WHO Publishes Guidelines on the Use of Quality Risk Management

In August 2010, the WHO published a draft guideline on quality risk management (QRM). The document is astonishingly detailed and gives, among others, guidance on official inspections regarding QRM. Read more here.

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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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08.09.10

WHO proposes new Sections for Guideline on Quality Assurance Topics

The World Health Organisation has proposed new sections for the WHO Good Manufacturing Practices (GMP) and has asked ECA to comment the new sections. Read more.

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08.09.10

FDA Fosters the Development of Better Medical Devices

Jeff Shuren, Head of the Center for Devices and Radiological Health (CDRH), has announced on the FDA website that the FDA intends to further the development of improved medical devices. With the example of infusion pumps, Shuren explains… Read more here.

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25.08.10

FDA publishes Q&As on Drug Recalls

The FDA recently published a set on Q&As on recall procedures in the section Questions and Answers on Current Good Manufacturing Practices. Read more.

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