Webinar: How to handle the new EU Site Master File (Part III EU GMP Guide)

How to handle the new EU Site Master File (Part III EU GMP Guide)

recorded on 3 June 2013


Costs

Non-ECA Members: EUR 199,--
ECA Members: EUR 149,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

How to handle the new EU Site Master File (Part III EU GMP Guide)
Speaker: Dr. Heinrich Prinz

Background
A company description (SMF - Site Master File) is requested from inspecting authorities before performing any GMP inspection. Recently, the creation of a Site Master File has also become part of the EU GMP Guide in Part III. In so far, the preparation of a Site Mater File concerns each single pharmaceutical company which is expecting a GMP inspection. For years now, a document from the Pharmaceutical Inspection Convention Scheme (PIC/S) under the current name PE 008 has been state of the art for questions regarding the development of an SMF. Version -3 of the PIC/S document provided companies very tight details on writing an SMF. The document - divided in requirements and “guidance” on how to interpret the requirements - was very helpful for many SMF writers.

The content of both documents (EU Site Master File and PIC/S document PE 008 in its current Version -4) are almost identical. Both documents have been definitely brought up to the current state of the art.

The changes made to the initial PIC/S document are considerable. They have affected all current SMFs created since then. Many detailed regulations have disappeared. “Guidance” as support doesn’t exist any longer. At the latest, during the next GMP inspection, authorities will expect an up-to-date Site Master File.

Educational Objectives
The Webinar aims to enable a comparison between the current PIC/S document (PE 008-4) and the requirements as laid down in Part III of the EU GMP Guide and the older version of the PIC/S document (PE 008-3), as well as to critically examine the changes made.

Site Master File Matrix/Template of imaginary company „Example“
To support you updating your existing Site Master File according to the new structure you will receive an extensive matrix with a step-by-step comparison between older and current version of the PIC/S document. You can see at a glance the changes made to the chapters and which detailed regulations have disappeared. This tool is very helpful to quickly identify significant changes and to transfer them into a new document. In addition, all participants will receive the template of a Site Master File of „imaginary company example” from the German Medicines Manufacturers´ Association. The template is bilingual: English and German.

Target Audience
The Webinar addresses staff members of pharmaceutical companies which are directly or indirectly involved in the creation of a Site Master Files and who would like to be informed about the latest changes. Staff members of API manufacturers, blood and blood component processing companies may also be interested by the topic.

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