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:
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:
Geneva, 27 August 2018: On 27 August 2018, the Bulgarian Drug Agency (BDA) applied for PIC/S membership. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Chicago (USA) on 24-25 September 2018.
Geneva, 13 August 2018: On 9 August 2018, the Jordan Food & Drug Administration (JFDA) applied for PIC/S pre-accession. The Rapporteurs will be appointed at the next PIC/S Committee meeting in Chicago (USA) on 24-25 September 2018.
Geneva, 20 June 2018: the following Chapters and Annex of the PIC/S GMP Guide have been revised:
The revised Chapters 3, 5 & 8 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. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management. Chapter 3 and 5 have been revised to include requirements to prevent cross-contamination. A change in the qualification of suppliers has also been introduced by revised Chapter 5. Expectations with regard to quality management system for the evaluation of quality defects in relation to product recalls have been expanded in Chapter 8, which has been entirely revised. Revised Annex 17 has been aligned with the EU revision of Annex 17 which will be published shortly by the European Commission (EC).
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 009-14) will enter into force on 1 July 2018. 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 009-14), please consult the page “Publications”
Geneva, 20 June 2018: the following new PIC/S Guidance documents have been adopted:
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).
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”
Geneva, 14 June 2017: PIC/S has adopted a new guidance on GMP inspection reliance (PI 048-1), which entered into force on 1 June 2018.
This guidance provides a tool and framework which aims to help Competent Authorities (CA) prioritise resources for GMP inspections for human and veterinary medicines. The main feature of the guidance is that it outlines a process for desk-top assessment of GMP compliance of overseas facilities to identify instances where an acceptable level of GMP compliance can be confirmed and assured from the activities of another CA or CAs without the need for an on-site inspection.
The guidance is based on a draft by the International Coalition of Medicines Regulatory Authorities (ICMRA) GMP Inspection Reliance Framework. It is a non-binding (i.e. applicable on a voluntary basis) high-level guidance for ICMRA and PIC/S Participating Authorities (PA) alike.
For more information see the PIC/S Newsletter of May 2018
To download the guidance, please consult the page “Publications” or click on the link below:
Geneva, 9 May 2018: the PIC/S Committee met on 17-18 April 2018 in Geneva (Switzerland), preceded by a meeting of the PIC/S Executive Bureau on 16-17 April 2018.
The press release regarding these meetings is available in newsletter format here or can be downloaded in pdf format from the link below:
Geneva, 5 April 2018: Registrations for the 2018 PIC/S Seminar on "Management of Risk through the Product Life-Cycle" (Chicago, 26-28 September 2018) are now open (for Medicines Regulatory Authorities only).
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The United States Food and Drug Administration (US FDA) is proud to announce that registration is now open for the PIC/S Committee Meeting and Seminar, hosted by US FDA from September 24 -28, 2018 in Chicago, Illinois.
The Seminar, entitled "Management of Risk through the Product Life-Cycle," will consist of interactive discussions, presentations, and workshops.
Risk management is critical to ensuring product quality, safety, and efficacy. The Seminar will explore the best practices impacting risk assessments and share tools and techniques generated from experienced inspectors and assessors to enhance inspections. It will be an ideal opportunity for both novice and experienced inspectors to refine their inspection skills through knowledge sharing and discussion.
For more information: click here