GMP News - Quality Assurance

21.04.10

New EMA Guidelines in Force for GMP Infringements by Manufacturers of Active Ingredients and CEP Revocation

The European Commission has adopted two documents which coordinate and concentrate the activities of the monitoring and licensing authorities in all EU Member States and the EDQM, in the event of serious GMP infringements by the manufacturers of active pharmaceutical ingredients and clinical test preparations. What are the consequences for the pharmaceutical manufacturer for example, of the withdrawal of a CEP from a supplier of active ingredients? Learn more here.

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31.03.10

Deviations and CAPA most frequent observations in FDA inspections

As evidenced in the Warning Letter report issued for ECA, shortcoming in the handling of deviations and the implementation of CAPA systems are among the most frequent GMP deviations objected by the FDA. Read more.

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24.03.10

European QP Association Releases Database "QPSHARE"

The European QP Association now released its new database "QPSHARE", allowing Qualified Persons to find potential partners for sharing audits. To read what's behind the new database please go here.

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17.03.10

Q-and-A List by EMA on the Centralised Procedure Extended

The questions/answers list by EMA deals with topics linked to the application for a marketing authorisation under the Centralised Procedure and provides a wealth of useful information on this subject. Some important questions have recently been added to these FAQs. Here you can read more.

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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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