PIC/S to resume onsite assessments for countries applying for membership
While the situation with Covid-19 has had an impact on in-person inspections for manufacturing sites, one inspection group is looking to make a big return to the manufacturing lines.
The Pharmaceutical Inspection Co-operation Scheme, or PIC/S, has announced that they plan to restart assessments for countries applying for membership. However, according to their 2022 work plan, the exact dates have not been determined yet.
PIC/S acknowledged that with the pandemic and other events, all assessments and reassessment visits were put on hold in 2020-21 and only a few processes have been able to happen virtually. So far only pre-accession processes in China, Bulgaria, and Saudi Arabia and a reassessment in New Zealand were able to go ahead.
“The objective for 2022 is to restart all assessments and reassessments and to reschedule all visits, subject to priorities and the availability of resources,” the work plan said.
On the back of the opening, several authorities have applied for accession or pre-accession status and will be evaluated this year. This includes applications for Armenia, Bulgaria, Jordan and Saudi Arabia and pre-applications for China and Azerbaijan.
Due to travel restrictions to Russia, the application by the competent authorities of Russia will be frozen until further notice.
Three on-site reassessments are also on the books in Taiwan, Indonesia and South Africa for later this year, while New Zealand will be a virtual reassessment.
PIC/S’s GMP Guide will also be further revised, in cooperation with the EMA’s Inspectors Working Group (IWG) on GMDP guidelines.
Also, several revisions will be either continued or finalized later this year. This includes the GMP guide for chapter one related to pharmaceutical quality systems as well as chapter four and annex 11 related to documentation and computerized systems. In 2021, the organization offered its guidance on on-site inspections for biopharma companies performing manufacturing (GMP) and distribution (GDP) activities.
This comes at a time when a report noted that the FDA completed less than half (48%) of its regulatory actions for pharma facilities designated as OAI or with an Official Action Indicated, within 6 months of an inspection closing, as the effects of Covid-19 had a great effect on general oversight at manufacturing sites last year.