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.
Geneva, 1 August 2016: the PIC/S Committee met on 4-5 July 2016 in Manchester (UK). The meeting was followed by the PIC/S annual training Seminar on 6-8 July 2016. The topic of the seminar was "Inspectorates of the Future".
The press release regarding these events is available in newsletter format here or can be downloaded in pdf format from the link below:
Registrations for the PIC/S - PDA API (Q7) Training Course in Puerto Rico (US) which will take place on 8-9 August 2016 in Puerto Rico are now open. For more information and registration, please click here.
The information flyer can be downloaded from the link below:
Geneva, 1 April 2016: Registrations for the 2016 PIC/S Seminar on "Inspectorates of the Future" (Manchester, 6-8 July 2016) are now open (for National Drug Regulatory Authorities only).
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The Medicines and Healthcare products Regulatory Agency (MHRA) UK is honoured to be the host of the 2016 PIC/S Seminar. This is an annual international event attended by both member and non-member authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme). The theme of the PIC/S 2016 Annual Seminar is "Inspectorates of the Future".
There are many factors affecting the work that Inspectorates do and what factors will drive them to do things differently in the future. This seminar will explore the current landscape with regard to inspection findings and trendings, with a particular focus on data integrity issues and then look to see what changes Industry have on the horizon. It will then also explore how various Inspectorates are collaborating on a number of topics and look to establish best practice for risk based inspections and compliance management. Finally, the seminar will look to what in the future PIC/S will be doing to support Inspector education through the PIA (PIC/S Inspectorates' Academy) and also the PIC/S vision to 2020.
For more information: click here
Geneva, 4 January 2016: On 1 January 2016, the Pharmacy and Poisons Board of Hong Kong SAR (PPBHK) as well as the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) became the 47th and 48th PIC/S Participating Authorities.