Geneva, 17 April 2012: On 10 April 2012, the Korea Food and Drug Administration (KFDA) applied for PIC/S membership. The Rapporteurs will be appointed at the next PIC/S Committee Meeting on 7-8 May 2012 in Geneva.

Geneva, 2 April 2012: The PIC/S Committee has adopted an Aide-Memoire on Assessment of Quality Risk Management Implementation (PI 038-1), which will enter into force on 2 April 2012.

The Aide-Memoire has been developed by the PIC/S Expert Circle on Quality Risk Management. The purpose of the document is to assist GMP inspectors in the assessment of QRM implementation in industry during regulatory inspections. Parts of the Aide-Memoire may also be useful (with suitable modification) during other GXP inspections where similiar principals of QRM also apply.

This Aide-Memoire should also contribute to a harmonised approach for inspection of QRM in industry between the different PIC/S Participating Authorities.

The document can be downloaded from the link below:

Geneva, 26 March 2012: On 9 March 2012 Japan's Ministry of Health, Labour and Welfare (MHLW) applied in its name as well as on behalf of the Pharmaceuticals and Medical Devices Agency (PMDA) and the Japanese Prefectures for PIC/S membership. The Rapporteurs will be appointed at the next PIC/S Committee Meeting on 7-8 May 2012 in Geneva.

Geneva, 16 February 2012: The PIC/S Expert Circle on Quality Risk Management has developed a Recommended Model for Risk-Based Planning in the GMP Environment (PI 037-1)

This PIC/S Recommendation sets out a simple and flexible Quality Risk Management tool that may be used by Inspectorates when planning the frequency and scope of GMP. It is a methodology that is based upon the concept of rating manufacturing sites on the basis of an estimated risk that they may pose to patients, consumers, animals and users of medicines. The methodology also takes into account the risk to product quality.

This document was adopted by the PIC/S Committee on 19 December 2011 and entered into force on 1 Januay 2012.

The document can be downloaded from the link below:

Geneva, 16 January 2012: the revised PIC/S Scheme which was formally adopted at the PIC/S Committee Meeting in Cape Town on 7-8 November 2011 entered into force on 1 January 2012.

The Scheme was revised in order to reflect several novelties concerning in particular the inclusion of a reference to Good Distribution Practices (GDP), the new PIC/S pre-accession process, structural changes as well as the better sharing of information and of confidentiality.

The revised PIC/S Scheme (PICS 01 95 (Rev 5)) can be downloaded from the link below:

Geneva, 18 November 2011: the PIC/S Committee met on 7-8 November 2011 in Cape Town (South Africa).

The meeting was followed by the PIC/S annual training seminar on 9-11 November. The topic of the seminar was "Good Pharmaceutical Inspection Practices".

The press release regarding these events can be downloaded from the link below: