PIC/S: TGA and Health Canada share experiences with mutually relying on other inspectors’ findings

23-05-2019

PIC/S: TGA and Health Canada share experiences with mutually relying on other inspectors’ findingsn

(Source: RAPS 2019-05-24)

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.

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.

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