GMP News - Quality Assurance

17.03.10

Memorandum of Understanding (MoU) signed between PIC/S and Russia

The Pharmaceutical Inspection Convention Scheme (PIC/S) provide an active and constructive co-operation in the field of GMP (Good Manufacturing Practice). Please read more about a new Memorandum of Understanding with Russia here

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08.03.10

EMA's Inspectors Working Group Publishes Work Plan 2010

An ambitious work plan for EMA's Inspectors Working Group points towards massive changes in the GMP-regulated environment. Here you can read which areas might be concerned.

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24.02.10

Inspection Results of the MHRA Published

From time to time, the MHRA publishes a summary of the results of the inspections conducted by the agency. Here you can find the current data.

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24.02.10

PQR and Management Review: Increasing Importance

With the recently published proposal for the revision of Chapter 1 Quality Management Systems of the EU GMP Guide, there will be an increasing focus on quality reviews like for example the PQR and Management Reviews. Read more.

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17.02.10

European QP Association To Release the Database "QPSHARE" Soon

The EU Qualified Person Association is in the final stage of releasing its database "QPSHARE" that will allow QPs to increase the efficiency of their companies’ supplier qualification with a unique tool. Click here to read more

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17.02.10

Warning Letters Report 2009 - Increasing number of Warning Letters

The insufficient investigation of deviations in the production process by the quality unit is the most frequent deficiency in the warning letters of fiscal year 09. Here you can read more on this topic.

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11.02.10

Overview of new and withdrawn FDA Guidances 2009

The FDA has published its annual list of new and withdrawn guidance documents. Read more.

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03.02.10

EC Commission Publishes Draft on the Creation of a Site Master File

The new draft by the EC Commission to create a Site Master File concerns all pharmaceutical enterprises. The Site Master File is the basis with which the supervisory authorities prepare for a GMP inspection. Here you can read more about the planned changes.

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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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27.01.10

PIC/S publishes Example of Methodology for the Implementation of Quality Risk Management (QRM) in pharmaceutical Industry

PIC/S published in the beginning of January a 30-page document as an example of a methodology for the implementation of Quality Risk Management (QRM) in pharmaceutical industry. Read more about this document here.

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27.01.10

Draft for the Revision of EU GMP Guide Chapter 2 "Personnel"

To integrate the principles of the ICH Guideline Q10 "Pharmaceutical Quality System" into the EU GMP Guide, the European Commission has published a draft for the revision of Chapter 2 "Personnel" for commenting by the public. The deadline for comments is 31 May 2010. Read more here.

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27.01.10

European Commission Publishes Proposal for Part 3 to the EC GMP Guide

On 4 January, the European Commission published a proposal for Part 3 to the EC GMP Guide. Part 1 concerning medicinal products and Part 2 for active pharmaceutical ingredients already exist. Part 3 now includes requirements on a Site Master File. Here you can read more.

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20.01.10

European Commission Publishes Proposal for Part 3 to the EC GMP Guide

On 4 January, the European Commission published a proposal for Part 3 to the EC GMP Guide. Part 1 concerning medicinal products and Part 2 for active pharmaceutical ingredients already exist. Part 3 now includes requirements on a Site Master File. Here you can read more.

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