News

December 2016

Revision of PIC/S GMP Guide (PE 009-13)

Geneva, 22 December 2016: the following Chapters of the PIC/S GMP Guide have been revised:

  • Chapter 1 on “Quality Management” (which has become “Pharmaceutical Quality Systems”); 
  • Chapter 2 on “Personnel”;
  • Chapter 6 on “Quality Control”; 
  • Chapter 7 on “Contract Manufacture and Analysis” (which has become “Outsources Activities”).

The revised Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. Chapters 1, 2 & 7 have been aligned to ICH Q10 and the principles of “Pharmaceutical Quality System” have been integrated. A section on consultants has been added in Chapter 2. The scope of Chapter 7 has been expanded beyond the scope of “contract manufacture and analysis”. Both Chapters 1 and 7 have been renamed to reflect the changes. In Chapter 6, all sections have been reviewed and amended and a new section on “Technical transfer of testing methods” has been added.

The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB). The revised GMP Guide (PE 009-13) will enter into force on 1st January 2017. All non-EEA Participating Authorities of PIC/S (and Applicants) have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

To download the revised GMP Guide (PE 009-13), please consult the page “Publications” or click on the link below:

December 2017

Joint targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide

Geneva, 20 December 2017: a revision of Annex 1 (Manufacture of Sterile Medicinal Products) of the PIC/S and EU GMP Guides has been prepared in co-operation with the European Medicines Agency (EMA), WHO and PIC/S in order to maintain global alignment of standards, achieving at the same time assurance for the highest quality. The document is subject to parallel public consultation by the European Commission, WHO and PIC/S.

The consultation period will last 3 months and run from 20 December 2017 to 20 March 2018.

Key changes from the earlier Annex 1 are:

  • introduction of new sections: scope, utilities, environmental and process monitoring sections and glossary
  • introduction of the principles of Quality Risk Management (QRM) to allow for the inclusion of new technologies and innovative processes 
  • restructuring to give more logical flow
  • addition of detail to provide further clarity.

In line with the PIC/S-EMA Harmonised Consultation Procedure, comments will be collected by the European Commission (EC). To download the consultation document and the template required to submit comments or for any queries in relation to this public consultation, please refer to the EC website by clicking “here”.

The consultation document is also published on the PIC/S website under the section Drafts on the page “Publications”.

October 2017

Pakistan applies for PIC/S pre-accession

Geneva, 16 October 2017: On 18 September 2017, the Drug Regulatory Authority of Pakistan (DRAP) applied for PIC/S pre-accession. The Rapporteurs will be appointed by written procedure.

October 2017

PIC/S events in Taipei, 11-15 September 2017

Geneva, 12 October 2017: the PIC/S Committee met on 11-12 September 2017 in Taipei (Chinese Taipei). The meeting was followed by the PIC/S annual training Seminar on 13-15 September 2017. The topic of the seminar was "Quality Control Laboratories: How to Inspect".

The press release regarding these events is available in newsletter format here or can be downloaded in pdf format from the link below:

September 2017

Iran / IFDA, Turkey / TMMDA and Mexico / COFEPRIS accede to PIC/S

Taipei, 13 September 2017: At its meeting of 11-12 September 2017 in Taipei (Chinese Taipei), the PIC/S Committee invited Iran's Food and Drug Administration (IFDA), the Turkish Medicines and Medical Devices Agency (TMMDA), and Mexico's Federal Commission for the Protection from Sanitary Risks (COFEPRIS) to join the Scheme from 1 January 2018. Iran / IFDA, Turkey / TMMDA and Mexico / COFEPRIS will become the 50th, 51st and 52nd PIC/S Participating Authorities.

August 2017

Russia applies for PIC/S pre-accession

Geneva, 28 August 2017: On 28 August 2017, the Ministry of Industry and Trade of the Russian Federation (Minpromtorg Russia), in charge of domestic GMP inspections, jointly with the Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”), in charge of foreign GMP inspections, applied for PIC/S pre-accession. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Taipei (Chinese Taipei) on 11-12 September 2017.