Geneva, 22 December 2016: the following Chapters of the PIC/S GMP Guide have been revised:
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:
Geneva, 14 December 2016: The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. Part of the National Competent Authorities are the (GMP) inspectorates in all different Member States in the European Economic Area.
PIC/S has a signed letter of agreement with the HMA, which entered into force on 15 August 2016, by which PIC/S and HMA agree to co-operate in exchanging information in the context of the EEA Joint Audit Programme (JAP) of GMP Inspectorates and the PIC/S Joint Reassessment Programme (JRP) of Participating Authorities.
For more information see the website: http://www.hma.eu
To download the letter of agreement (PS/W 18/2016), please consult the page “Publications” or click on the link below:
Geneva, 30 August 2016: On 26 August 2016, the Directorate General for Animal Health and Veterinary Medicinal Products (DGSAF) - Ministry of Health of Italy applied for PIC/S membership. The Rapporteurs will be appointed by written procedure.
Geneva, 10 August 2016: PIC/S has published on a draft basis a guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonised Data Integrity guidance, considering the impact to public health. The purpose of the trial-period is to learn from implementation. It is acknowledged that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions. This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures - including possibly an industry consultation - on a revised version after completion of the trial-period.
To download the draft guidance (PI 041-1 (Draft 2)), please consult the page “Publications” or click on the link below:
Geneva, 1 August 2016: On 1 August 2016, Thailand's Food and Drug Administration (Thai FDA) became the 49th PIC/S Participating Authority.