PIC/S Committee Meeting on 24 October 2000

GMP News Nr. 89

GMP News
19 January 2001

 

PIC/S Committee Meeting
on 24 October 2000

A meeting of the PIC Committee of Officials and of the PIC/S Committee took place in Colmar, France on 24 October 2000. The most important resolutions are summarized in the press release of 8 November 2000 http://www.picscheme.org/pubs/press/prnov00.htm

  • Cooperation with the EMEA: adoption of a document concerning the harmonization between the PIC/S and the EU

  • Inspector training: The PIC/S Joint Visits Program is very successful. Six new groups were formed and the composition of 3 existing groups changed. There are currently 17 joint visit groups in existence.

  • PIC/S Guidance Documents: The committee approved 2 new documents, entering into force on 1 January 2001

    • PIC/S internal recommendation on Quality System Requirements for Pharmaceutical Inspectorates (PI 002-1)

    • Manufacture of Products Derived from Human Blood and Human Plasma; superseding Annex 12 of the PIC Guide

    In addition, the following draft documents were discussed

    • Draft Guidance on Parametric Release (PR 2/99-1 Draft 7)

    • Draft Revised Annex on Medicinal Gases (PE 003-1 Draft 3)

    • Draft Recommendations on Isolator Technology (PE 004-1 Draft)

    • Draft GMP Guide for Blood Centres (PE 005-1 Draft 4)

    • Draft Guide on Best Practices for Computerized Systems in regulated "GxP" Environments (PE 006-1 Draft 1)

    The PIC/S drafts, which are released for comments by industry, may be downloaded as Word or pdf files from the PIC/S website (www.picscheme.org/overview/whatsnew.htm).

    The PIC/S drafts, which are released for comments by industry, may be downloaded as Word or pdf files from the PIC/S website http://www.picscheme.org/overview/whatsnew.htm

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