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).
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 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.
The revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide entered into force on 25 August 2023 and has been published on https://picscheme.org/en/publications. It entered into operation the same day as the revised Annex 1 of the EU GMP Guide, which is identical with PIC/S Annex 1 (with some minor differences). The revised Annex 1 is now applicable with the exception of paragraph 8.123. This paragraph has a later date of entry into force, which is on 25 August 2024. For the background to the revision of Annex 1, see https://picscheme.org/en/news?dateselect=2022
The revised Annex 1 is an integral part of the PIC/S GMP Guide (PE 009-17), which has also been revised. The GMP Guide has 4 parts: Introduction, Part I, Part II, and Annexes. Annex 1 can be found under ‘PIC/S GMP Guide (PE 009-17) Annexes’.
Geneva, 7 August 2023: On 20 June 2023, Philippines Food and Drug Administration (FDA PH) submitted a complete membership application to PIC/S.
The Rapporteur(s) will be appointed by written procedure.
Geneva, 2 August 2023: Registrations for the 2023 PIC/S Seminar on “Soft Skills that Make a Good GMP/GDP Inspector in 2023” which will be hosted by Thai FDA from 8-10 November 2023 are now open (for Medicines Regulatory Authorities only). Deadline for registration is 31 October 2023.
For more information, please contact the PIC/S Secretariat.
Geneva, 12 June 2023: The PIC/S Committee has invited Bulgaria’s Bulgarian Drug Agency (BDA) and Saudi Arabia’s Saudi Food and Drug Authority (SFDA) to join the PIC Scheme.
Bulgaria / BDA will become PIC/S’ 55th Participating Authority and Saudi Arabia / SFDA PIC/S 56th Participating Authority as from 1 July 2023.
BDA submitted a complete membership application in August 2018. The PIC/S assessment was combined with a Canadian MRA assessment and EMA JAP audit. A paper assessment was carried out followed by a joint tripartite PIC/S – EMA - Canada MRA on-site assessment visit which took place in February 2023, after establishment of the new system for the GMP Inspectorate of BDA [following a JAP audit in 2018]. The assessment report was finalised in April 2023. The Audit team recommended to the Committee to accept the PIC/S membership application of BDA, which was endorsed by the PIC/S Sub-Committee on Compliance (SCC). At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee then unanimously accepted the membership of BDA in PIC/S as from 1 July 2023.
SFDA submitted a complete membership application in February 2020, after successfully completing the pre-accession process. This facilitated the accession process. A paper assessment was carried out followed by an on-site assessment visit which took place in March 2023. The assessment report was finalised in the course of April 2023. The Audit team recommended to the Committee to accept the PIC/S membership application of SFDA, which was endorsed by the PIC/S Sub-Committee on Compliance (SCC). At its meeting in Geneva on 11-12 May 2023, the PIC/S Committee then unanimously accepted the membership of SFDA in PIC/S as from 1 July 2023.
Geneva, 12 June 2023: A new PIC/S Deputy Chairperson and a new PIC/S Sub-Committee on Strategic Development (SCSD) Chair took office on 11 May 2023. Due to the retirement from her Agency of the former PIC/S Deputy Chairperson and SCSD Chairperson, Susan Laska (US FDA), the PIC/S Committee carried out by-elections at its last meeting in Geneva on 11-12 May 2023. It unanimously elected Mr Jacques Morénas (France / ANSM) as new PIC/S Deputy Chairperson - in addition to his current position of PIC/S Sub-Committee on Training (SCT) Chair - and elected Ms Jennifer Burnett (Australia / TGA) as new PIC/S Sub-Committee on Strategic Development (SCSD) Chair. All other Executive Bureau Members remain the same.
With these changes, the new composition of the Executive Bureau for the remaining of the period 2022-2023 consists of: