PIC/S Reports Progress By Some Inspectorates In Adopting 'Desktop' Audits
Health Canada and Australia's TGA impart how they are using the PIC/S "desktop" audit model to maximize resources by avoiding duplicate inspections.
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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.
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.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”