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Guidance Documents

The Committee adopted the final draft of the PIC/S Guide to Good Practices for the Preparation of Medicinal Products* (PE 010-1 (Draft 3)). This guide will present the basic requirements for the preparation of medicinal products by healthcare establishments for direct supply to patients. It will be published on the PIC/S website (www.picscheme.org) after final editing. The Committee also approved the revision of two guidance documents regarding the drafting of PIC/S documents (PI 001-5 and PI 029-1).

Relations with other Organisations European Union

The Committee noted that a co-operation agreement in the form of a Memorandum of Understanding (regarding the training of GMP inspectors, the exchange of information on guidance documents and audits of GMP inspectorates) had been negotiated with the European Medicines Agency (EMEA) and was expected to be signed by the end of 2007. A similar agreement (regarding the sharing of information, consultation on guidance documents and training in the field of APIs) was concluded in July 2007 between PIC/S and the European Directorate for the Quality of Medicines & HealthCare (EDQM).

WHO

PIC/S and WHO’s Department of Immunization, Vaccines and Biologicals (IVB) are in the process to negotiate a co-operation agreement (regarding the exchange of information, training and harmonisation of audit tools).

For information on co-operation with ASEAN and ISPE see page 5.

In brief The Committee …

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    re-elected Mr. Paul Hargreaves (United Kingdom / MHRA) as Member of the Executive Bureau for the period 2008-2009;

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    adopted a revision of the PIC Scheme (new chapter on the reorganisation of Participating Authorities and revised chapter on the sharing of information);

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    revised the PIC/S Audit Checklist which was harmonised with the EU JAP Audit Checklist;

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    adopted the revised PIC/S Accession Guidelines (new facilitated procedure for Authorities having been assessed by two PIC/S Participating Authorities);

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    approved the 2008 budget and adopted the revised Financial Rules;

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    adopted a template for Participating Authorities to share information on inspections in non-PIC/S countries;

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    noted an oral report by the Chairman on the last meeting of the Executive Bureau (Sunday 18 November);

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    confirmed that next meetings would take place in Krakow (Poland) on 26-27 May 2008 and in Geneva (Switzerland) on 11-12 November 2008.

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The title of the document may be subject to modification.

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