Module 5 Presentations

05/07/2024

Is a Clinical QMS ‘just’ about GCP (1)?

• GMP (Good Manufacturing Practice) Aspects: Quality & Release of Investigational Medical Product • GDP (Good Distribution Practice) Aspects: Shipment & Storage of Investigational medicinal product • GPV (Good Pharmacovigilance Practice) Aspects: Link to Safety Database of Product / Signal Detection • Regulatory: Interactions with Ethics Committees / Competent Authorities for trial submission & Dossiers • Procurement Aspects: Vendor Selection / EHS Aspects / Code of Conduct • Computerized Systems: E.g. for Statistical Analysis (validation requirements!) • QA: TQA (technical Quality Agreements), Audits, Deviations & CAPAs (Corrective and Preventive Measures), Inspections • Legal Aspects: Contracts & Data Protection requirements

The Organisation for Professionals in Regulatory Affairs

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Is a Clinical QMS ‘just’ about GCP (2)?

• Running Clinical Trials has multiple intersection with other GxPs • Must be integrated into Sponsor’s organizational requirements • Must be integrated into Sponsor’s general Pharmaceutical Quality System (ICH Q10)

The Organisation for Professionals in Regulatory Affairs

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