World's Pharmaceutical Inspectorates Focus On Increased Mutual Reliance
Implementing Desktop Assessments Primary Focus For PIC/S This Year
Launching desktop assessments to ease the inspectional workload of regulators and forging stronger relationships with India and China are two key priorities for the international inspectorate group this year.
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Agency describes criteria for waiving routine prequalification inspections for existing drugs and vaccines as well as new products in light of COVID-19.
Health Canada and Australia's TGA impart how they are using the PIC/S "desktop" audit model to maximize resources by avoiding duplicate inspections.
A new guideline has been adopted by PIC/S, the group representing international pharmaceutical inspectorates, to help regulators assess whether GMP compliance at foreign sites has been established by the hosting competent authority, without the need for an on-site visit.