Module 5 Presentations

The Future?

• A hybrid approach to GCP inspections will continue to be used.

• Positive response from industry: • supports health and safety of the company staff. • allows for greater flexibility with work schedule of inspectees. • motivation to continue standards of compliance even in extreme change. • Also a benefit to the public: • facilitates maintenance of pharmaceutical supply chain. • enables oversight that could accelerate the approval process. • continues to promote access to promising innovative therapies.

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Classification of Findings

Critical, Major, Other, Observations and Recommendations

Critical Findings: Referred to Inspection Action Group (IAG) a non-statutory, multi disciplinary group made of MHRA division management • IAG1: GMP, GDP, Blood Establishments. • IAG2: GCP, GPvP. • 12 scheduled meetings per year. Possible Actions • Issuing an infringement notice in relation to a clinical trial. • Suspending or revoking a clinical trial authorisation. • Suspension of Phase I accreditation. • Follow-up inspections or triggered inspections at related organisations (e.g. issues in GCP may trigger a GMP inspection). • Enforcement or prosecution.

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