Almost a year after the Pharmaceutical Inspection Co-operation Scheme (PIC/S) adopted a new guideline allowing regulators to rely on their peers’ good manufacturing practice (GMP) inspections, Health Canada and Australia’s Therapeutic Goods Administration (TGA) shared some early results.
According to the guidance, PIC/S members can use so-called “desktop assessments” to waive GMP inspections because an acceptable level of compliance has been established by another PIC/S member. Beginning in January, PIC/S members began tracking metrics related to the use of other members’ GMP inspection reports.
“In most cases, the availability of a GMP certificate or an inspection report will provide sufficient information regarding compliance to enable another Member to make an informed regulatory decision to waive their inspection,” PIC/S said. The guideline also notes that additional risk information may be requested from a manufacturer to aid an assessment.
As far as results so far, TGA reported that currently about 92% of GMP approvals for products registered or listed in Australia utilize the desktop assessments.
“To date, there are ~207 manufacturing sites that are subject to TGA inspections and ~2700 overseas manufacturing sites that rely on evidence from recognized regulators. TGA also provided statistics over the last few years on the number of GMP Clearance applications received. For the fiscal year 2017/2018, this amounted to 5327 GMP clearance applications,” PIC/S reported.
Health Canada, meanwhile, offered statistics from the past few years on GMP assessments for foreign sites through its desktop assessment process. “For the fiscal year 2018/2019 this included exchange of Certificates of Compliance (500+) under a mutual recognition agreement (MRA) or through desk-top assessments (600+) by reviewing GMP compliance information from a foreign regulator or consultant audit,” PIC/S said.
Further experience and figures shared at the April PIC/S committee meeting in Geneva, including those from Singapore’s Health Sciences Authority, demonstrated “how hugely successful such reliance programmes are and how they allow Members to allocate inspection resources more appropriately through better leveraging of resources and information where possible. Such examples also show the benefits of mutual reliance which can be further strengthened between Members,” PIC/S added.
As of 1 May, PIC/S is made up of 52 member regulators, four applicants (Armenia, Brazil, Bulgaria and Italy) and five pre-applicants (Bangladesh, Jordan, Pakistan, Russia and Saudi Arabia). A delegation from China's National Medical Products Administration (NMPA) also met with PIC/S executives to address some issues raised by NMPA in connection with a possible future PIC/S application.
In addition to the early results related to the PI 048-1 Guidance on GMP Inspection Reliance
, PIC/S also said an annual seminar on "Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex 1" will be hosted by Japan's Ministry of Health, Labour and Welfare and Pharmaceuticals and Medicinal Devices Agency in Toyama, Japan from 13-15 November 2019.
The 2020 PIC/S annual seminar will be hosted by Thailand’s FDA in Bangkok in November 2020 and will focus on “How to be a good GMP Inspector” and/or “How Best Practices and Skills could be built into a GMP Inspectorate Unit.”
In addition, a proposal by Ireland’s HPRA to host the 2021 PIC/S annual seminar in Ireland was welcomed by the Committee.