Module 3 Presentations

07/05/2024

Key Documents for the QP

PSF (Annex 13 / EU 2017/1572 

CTA

Order

SC MAP

• Specifications and analytical methods • Manufacturing methods • In-process testing and methods; •Approved label copy •Relevant CTAs & amendments •Relevant clinical trial protocols and randomisation codes; •Relevant technical agreements with contract givers •Plans & arrangements for reference & retention samples; •Stability data; Storage and shipment conditions. •Details of the supply chain

•CMC Information

•the instruction to process, packaging and or ship a certain number of units of IMP. •given by or on behalf of the sponsor in written or electronic form •Formally authorised •Refer Product Specification

•Entire supply chain •API & DP

•Clinical Information relevant to IMP •Labels

•Include the manufacturing sites of the starting & and packaging materials for the medicinal product or DP •Any other materials deemed critical through a risk assessment of the manufacturing process. •Include subcontractors of critical steps such as the sterilisation of components and equipment for aseptic processing.

•sIMPD / NIMP Dossier •Clinical Trial Protocol •EudraCT form / IRAS form •QP Declaration

File and the relevant clinical trial protocol

The Organisation for Professionals in Regulatory Affairs

21

How QPs assure CTA compliance

• Internal Processes that ensure the PSF matches the CTA • Robust Change Control • Main body text • Including Regulatory Change Control • Including Approval Commitments • Visibility of current regulatory commitment • Do and Tell ---> Tell and wait approval • Visibility of initial approval status for the CTA • Visibility of amendment approval status for amendments to the CTA

The sponsor may take responsibility for this after certification

The Organisation for Professionals in Regulatory Affairs

22

11