The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency’s prequalifications programs.
Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of harms to the product and individuals, according to guidance issued 14 May by the WHO Prequalification Unit – Inspection Team (PQT/INS).
Recognizing that the impact of the coronavirus and associated governmental and public health measures vary by country and region, the guidance specifically addresses regulatory expectations and permitted flexibility during the pandemic.
WHO PQT/INS will consider waiving or postponing a routine site inspection for organizations that have already been inspected, provided a successful past prequalification inspection has been held.
Waiver of onsite inspection for new products under prequalification also will be considered, provided a successful prequalification inspection has occurred. For the addition of a new manufacturing site for a prequalified product, a waiver of onsite inspections may be considered if another regulatory body has performed a successful inspection.
If a new organization has a new product under assessment, WHO PQT/INS “may consider waiving an onsite inspection on a case by case basis for high priority medicines, vaccines, medical devices including IVDs, vector control products and related organizations.”
Quality Control Laboratory inspections are “not considered a priority during the COVID-19 pandemic,” and postponement may be considered on a case-by-case basis. A desk assessment may also be considered.
In all circumstances where a desk assessment may be permitted, WHO PQT/INS notes that onsite inspections may be necessary when travel restrictions are lifted if a desk assessment does not fulfill “the purpose and requirement of the inspection.”…