A Memorandum of Understanding (MoU) was signed in Moscow on 12 February 2010 between the PIC/S Chairman and the Head of the Federal Service on Surveillance in Healthcare and Social Development in the Russian Federation (Roszdravnadzor).

The MoU aims at facilitating Roszdravnadzor's application for PIC/S membership (and accession to PIC/S).

The MoU will only come into effect after its formal approval by the PIC/S Committee at its next meeting in Geneva on 19-20 May.

An informal Working Group within PIC/S has developed an example of methodology for the implementation of Quality Risk Management (QRM) in industry.

This example of methodology is not intended to be issued by PIC/S as a recommendation or as a guideline for industry and / or for GMP inspectors but it could be used by PIC/S for training purposes.

Whether this example is used by industry for other purposes is of no concern to PIC/S and will not influence the outcome of PIC/S inspections.

To download the document click on the link below:

PIC/S has published a revised version of the recently adopted Recommendation for the technical interpretation of Annex 1 to the PIC/S GMP Guide, which has been prepared by Switzerland / Swissmedic.

The revised Recommendation is the outcome of recent consultations of EEA and PIC/S Competent Authorities in order to reach a common document between the EEA and PIC/S.

The Recommendation summarises the interpretations which an inspector from a national regulatory authority should adopt when performing an inspection of a manufacturer of sterile medicinal products.

The PIC/S Committee met in Uppsala (Sweden) on 2-3 November 2009.

Main highlights:

♦ Election of new Chairman and Deputy Chairpersons;

♦ Enlarged Executive Bureau to better reflect regional representation in PIC/S;

♦ US FDA application for PIC/S membership: giant leap forward;

♦ Adoption of technical interpretation or revised Annex 1 to PIC/S GMP Guide

The meeting was followed by the annual PIC/S Seminar on "Aseptic & Sterile manufacturing from APIs to finished dosage forms". The Seminar was attended by more than 100 participants from almost 50 national regulatory authorities or international organisations from all continents.

To download the Press Release click on the link below:

The revised PIC/S GMP Guide (PE 009-9) was adopted by the PIC/S Committee at its meeting in Geneva on 5-6 May 2009. The revision concerns Annex 3.

The revised PIC/S GMP Guide entered into force on 1 September 2009.

On 1 July 2009 Lithuania's State Medicines Control Agency (SMCA) became the 37th PIC/S Participating Authority.

On 1 June 2009 the Philippines' Bureau of Food and Drugs applied for PIC/S membership.

On 27 May 2009 PIC/S and the World Health Organization (WHO) signed a co-operation arrangement.  The co-operation will be implemented between PIC/S and WHO’s team on Quality Assurance and Safety and WHO’s team on Biologicals and Medicines. It will focus on the training of inspectors and on the sharing of documents.