IPEC e-newsletter - Excipients Insight June 2018 - 19-06-18


Inside this issue


Could desktop assessment reduce EU on-site inspections?

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new, non-binding guidance on Good Manufacturing Practice (GMP) inspections which includes a new process for desktop assessment of GMP compliance.

The desktop assessments would help regulators prioritise resources for GMP inspections, where demand “far exceeds what any one [competent authority] can accomplish.” The new form of assessment would be deployed “instances where an acceptable level of GMP compliance can be confirmed and assured from the activities of another CA or CAs without the need for an on-site inspection,” says PIC/S in its latest newsletter.

A schematic of the desktop assessment appears below:

PIC/S says the adoption of the new guidance highlights efforts to improve sharing of information between authorities.




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