News

January 1970

PIC/S Seminar 2020

Geneva, 6 October 2020: Registrations for the 2020 PIC/S Seminar on "Distant Assessment of GMP Compliance" which will be hosted virtually from 8-10 December 2020 are now open (for Medicines Regulatory Authorities only). Deadline for registration is 8 November 2020.

For more information,  please contact the PIC/S Secretariat.

seminar 2020

 

2020 Seminar on “Distant Assessment of GMP Compliance"  

The Finnish Medicines Agency (FIMEA) is hosting on-line the 2020 PIC/S Seminar on “Distant Assessment of GMP Compliance" on 8-10 December 2020.

This Seminar on Distant Assessment of GMP Compliance places special emphasis on real-time interactive assessment using ITC (Information Technology and Communication) tools. Distant assessment in the context of the Seminar is an interchangeable term with remote or virtual inspections.

The Seminar programme contains presentations and discussions on the implementation of distant GMP assessment/inspection activities in different jurisdictions and on information security in virtual real-time communications. We also look to share the experiences of inspectors involved in off-site GMP assessment/inspections as well as those inspected.

The Seminar is open to the participation of inspectors from medicines regulatory authorities around the world.

For more information, please contact the PIC/S Secretariat.

October 2020

PIC/S Expert Circle on Quality Risk Management (QRM) webinar, hosted by Turkey / TMMDA, 24 September 2020

Geneva, 19 October 2020: On 24 September 2020 a webinar meeting of the PIC/S Expert Circle on Quality Risk Management (QRM), was hosted by the Turkish Medicines and Medical Devices Agency (TMMDA).

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This PIC/S Expert Circle, currently chaired by Ireland / HPRA, has been active in developing and running advanced QRM training for GMP Inspectors for several years now to enable them to more effectively inspect the application of risk assessment and QRM during inspections in a harmonised manner. It also enables Inspectors to effectively use the PIC/S Recommendation in relation to risk-based GMP inspection planning (PI 037-1).

This webinar, which included some training aspects, was solely for GMP inspectors, and allowed to discuss updates and progress on applicable QRM guidance.

In particular, it led to important developments on:

  • The revision of the PIC/S Aide Memoire on inspecting the implementation of QRM (PI 038-1) including discussions on the revision work in progress and gathering feedback on what the revised Aide Memoire should address;
  • The QRM Curriculum and the QRM e-Module being developed for the PIC/S Inspectorates’ Academy (PIA) and how these might be used by Inspectorates;
  • The PIC/S Recommendation Paper on Evaluating and Demonstrating the Effectiveness of the Pharmaceutical Quality System (PQS) with respect to Risk-based Change Management (PI 054-1 (Draft 1)) currently being applied on a trial basis by PIC/S Participating Authorities. See also interview of the Chair of the Expert Circle on this topic in Press Release of December 2019;
  • ICH Q12 and its relevance for GMP Inspectors, in particular training under development by the PIC/S Working Group on ICH Q12 Training Materials, chaired by France / ANSM, and the value of PI 054-1 (Draft 1) in this perspective.

The webinar was attended by more than 200 inspectors from more than 50 countries / entities, including PIC/S Members, (Pre-)Applicants, Partners as well as a large number of non-PIC/S Member Medicines Regulatory Authorities, namely from Chad, Congo, Gambia, Ghana, India, Kenya, Libya, Malawi, Namibia, Philippines, Russian Federation, Sierra Leone, Somaliland, Sri Lanka, Tanzania, Tunisia, Uganda, Yemen, Zambia and Zimbabwe.

For some of these non-Members, in particular from Africa, this was the first time they were attending a PIC/S event.

In addition to its Members (53), Applicants (4), Pre-Applicants (4) and Partners (EDQM, EMA, OIE, UNICEF and WHO), PIC/S as a global organisation very much welcomes interest and opportunities for engagement with non-Member Medicines Regulatory Authorities, even if they are not yet ready to submit a PIC/S accession or pre-accession application.

This also underlines the importance of one of PIC/S most important projects, the PIC/S Inspectorates’ Academy, which is a Global Capacity and Training Initiative aiming at delivering inspection excellence through harmonised training in the field of GMP to ensure that high quality standards for medicinal products are met worldwide in the interest of public health.

For these reasons, the recording of this webinar will be made available via the PIC/S Inspectorates’ Academy to any interested non-Member Medicines Regulatory Authorities. This will include French and Portuguese language versions thanks to the good works of Oakes Group Global and their Africa-wide PIC/S Initiative (AwPI) efforts.  AwPI is an initiative independent from PIC/S that is promoting PIC/S with non-Member authorities in Africa and will be making possible the translation to French and Portuguese. Information will be posted on the PIC/S website once this is available for non-Member Medicines Regulatory Authorities.

August 2020

Azerbaijan applies for pre-accession

Geneva, 21 August 2020: On 18 August 2020, the Analytical Expertise Center (AEC) – Ministry of Health of Azerbaijan applied for PIC/S pre-accession. The Rapporteurs will be appointed by written procedure.

June 2020

Adoption and Entry into Force of New PIC/S Guidance Documents (PI 052-1 and PI 053-1)

Geneva, 1 June 2020:  The following new PIC/S guidance documents have been successfully adopted: 

  • PI 052-1 Aide-memoire - Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management
  • PI 053-1 Questions and Answers on Implementation of Risk-based Prevention of Cross-contamination in Production and ‘Guideline on Setting Health-Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’

The documents, which have been successfully developed by the PIC/S Expert Circle on Controlling Cross-Contamination in Shared Facilities, led by UK / MHRA, entered into force on 1 June 2020.

To download these documents (PI 052-1 and PI 053-1), please consult the page “Publications” or click on the links below:

February 2020

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

Deadline postponed for the second targeted consultation on Annex 1

Due to the challenges posed by COVID-19, the timeline for the second targeted consultation has been extended until 20 July 2020.

 

Those who have already submitted their comments are welcome to revise their contribution if they would like to. Only their latest comments will be considered.

 

The European Commission remain at your disposal in case you would have any further questions at : SANTE-REVISION-OF-ANNEX-1@ec.europa.eu

 

 

Geneva, 20 February 2020:

Period of consultation:

From 20 February 2020 to 20 July 2020.

Objective of the consultation:

Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients.

Since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow. Key changes are:

  • Introduction of new sections;
  • Introduction of QRM Principles;
  • Restructured to give more logical flow;
  • Added detail to a number of the previous sections to provide further clarity.

A first consultation conducted from 20 December 2017 to 20 March 2018 allowed about 140 companies and/or organizations to comment. The joint PIC/S-EMA drafting group (with WHO participation) processed more than 6200 lines of comments.

Due to widespread interest from industry following the first consultation, and because of substantial modifications introduced in several sections, the European Commission (EC), the European Medicines Agency (EMA), WHO and PIC/S have jointly agreed to engage with stakeholders a second targeted consultation on the updated draft guidance (version 12) focused on the sections and/or significantly modified paragraphs that raised most concerns by stakeholders.

The second targeted consultation aims at collecting experience from the sectors on certain manufacturing steps. PIC/S therefore expect to receive contribution from the associations representing the sectors.

Acknowledgment

In order to maintain the global alignment of standards, achieving at the same time assurance for the highest quality, the document will be, in parallel, subject to a second joint targeted consultation by the EC / EMA, WHO and PIC/S.

Joint Consultation Process

In line with the PIC/S-EMA Harmonised Consultation Procedure, comments will be collected by the EC as well as a number of organisations representing relevant stakeholders, which have agreed to receive all the comments of this second consultation from their members, to compile and send the comments to the European Commission. For the list of stakeholders, please refer to the EC website (link provided below), in particular the section on “Targeted Stakeholders”.

To download the consultation document and the template required to submit comments as well as for the process on how to submit comments, please refer to the EC website by clicking “here” - see in particular the section on “How to submit a contribution”.

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

February 2020

Saudi Arabia applies for PIC/S membership

Geneva, 19 February 2020: On 17 February 2020, the Saudi Food & Drug Authority (SFDA) applied for PIC/S membership. The Rapporteurs will be appointed by written procedure.