Australia’s Therapeutic Goods Administration (TGA) published comprehensive metrics on its GMP oversight performance during the second half of 2016. Provided were the number of: ● products investigated for compliance issues ● completed regulatory compliance investigations ● GMP clearance applications, and ● drug product recalls. TGA had revised their practices to apply a risk-based approach to the scheduling of inspections, which resulted in significant improvements in processing times. The improvements have been achieved by focusing on initial inspections, and taking into account any history of consistent compliance with GMP guidelines over time.
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