News

June 2018

New PIC/S Guidance Documents (PI 043-1; PI 045-1; PI 046-1; and PI 047-1)

Geneva, 20 June 2018: the following new PIC/S Guidance documents have been adopted:

  • PIC/S Aide-Memoire on “Cross-Contamination in Shared Facilities” (PI 043-1).

The purpose of this Aide-Memoire is to assist GMP inspectors in the assessment of the risks to the product from cross-contamination in shared facilities. This document provides guidance for GMP inspectors to use in preparation for, and performance of, inspections. It promotes a risk-based approach. This new Aide-Memoire has been successfully developed by the PIC/S Working Group on Controlling Cross Contamination in Shared Facilities, led by Graeme McKilligan (UK / MHRA) and the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB).

  • PIC/S Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (PI 045-1);
  • PIC/S Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1);
  • PIC/S Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1).

These PIC/S Guidelines transpose for PIC/S purposes the corresponding European Commission (EC) guidance documents. This transposition further strengthens harmonisation between PIC/S and the EU. The Guidelines are in essence equivalent with some minor editorial differences. The Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities is also closely linked to revised Chapter 5 of the PIC/S GMP Guide.

The transposition of these Guidelines has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB).

The new PIC/S Aide-Memoire and PIC/S Guidelines will enter into force on 1 July 2018 and are applicable on a voluntary basis.

To download the PIC/S Aide-Memoire on Cross-Contamination in Shared Facilities (PI 043-1) and the PIC/S Guidelines (PI 045-1); (PI 046-1) and (PI 047-1), please consult the page “Publications

May 2019

PIC/S meetings in Geneva, Switzerland, 8-10 April 2019

Geneva, 21 May 2019: the PIC/S Committee met on 9-10 April 2019 in Geneva (Switzerland), preceded by a meeting of the PIC/S Executive Bureau on 8-9 April 2019.

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

May 2019

2019 PIC/S Seminar (Toyama, Japan)

Geneva, 20 May 2019: Registrations for the 2019 PIC/S Seminar on "Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex 1" (Toyama, 13-15 November 2019) are now open (for Medicines Regulatory Authorities only).

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Seminar 2019 logo

The 2019 PIC/S Annual Seminar on "Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex 1" will be hosted by Japan's Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medicinal Devices Agency (PMDA) in Toyama (Japan) from 13-15 November 2019.

The Seminar will focus on Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex 1 and will consist of interactive discussions, presentations and workshops. It will be an ideal opportunity for both novice and experienced inspectors to enhance their inspection skills through knowledge sharing and discussion. This Seminar is intended to provide a further understanding of PIC/S GMP Guide Annex 1 based on issues discussed during its ongoing revision and through a case study of sterility assurance. The Seminar will also allow participants to acquire skills on how to make risk based decisions during GMP inspections. Workshops will be supported by the use of videos of practical manufacturing operations in order to stimulate active discussions.

Registrations to the PIC/S Seminar 2019 are now open (for Medicines Regulatory Authorities only).

For more information and registration click here

March 2019

Bangladesh applies for PIC/S pre-accession

Geneva, 5 March 2019: On 26 February 2019, Bangladesh's Directorate General of Drug Administration (DGDA) applied for PIC/S pre-accession. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Geneva (Switzerland) on 9-10 April 2019.

November 2018

Focused stakeholders consultation on revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

Geneva, 30 November 2018: a revised Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 3)) has been prepared by the PIC/S Working Group on Data Integrity, co-led by Australia / TGA and UK / MHRA.

The purpose of the guidance is to serve to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonised approach to the inspection, including reporting in regards to data management and integrity. A first draft (PI 041-1 (Draft 2)) was published by PIC/S on a trial basis in August 2016. Following feedback received from PIC/S Participating Authorities during its 6-month implementation trial-period, the draft of this guidance has been updated and expanded by the Working Group.

The document (PI 041-1 (Draft 3)) is subject to a focused stakeholder consultation seeking substantive comments from trade and professional associations on specific questions relating to the proportionality, clarity and implementation of the guidance requirements. In parallel to this stakeholder consultation, the new draft will be applied by PIC/S Participating Authorities on a trial basis for a new implementation trial period.

The consultation period will last 3 months and run from 30 November 2018 to 28 February 2019.

To submit feedback, please provide feedback exclusively on the dedicated template available on the websites of the below associations and submit by e-mail with subject line "PIC/S Focused Public Consultation – Data Management and Integrity" to one of the following associations which will collect and compile responses. Stakeholders should only reply once.

To download the consultation document (PI 041-1 (Draft 3)) please consult the page “Publications” or click on the link below:

October 2018

PIC/S events in Chicago, United States, 24-28 September 2018

Geneva, 31 October 2018: the PIC/S Committee met on 24-25 September 2018 in Chicago, Illinois (USA). The meeting was followed by the PIC/S annual training Seminar on 26-28 September 2018. The topic of the seminar was "Management of Risk Through the Product Life-Cycle".

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