Module 5 Presentations

18/07/2024

The legal duties of the IMP QP

• IMPs manufactured in a member state – each batch has been manufactured and checked to: – GMP – PSF ( Product Specification File) – Appropriate authorisations • IMPs manufactured in a 3 rd country and imported into EU have been manufactured to GMP at least equivalent to 2003/94/EC • Comparators sourced outside the EU and have a marketing authorisation have been manufactured to GMP at least equivalent to 2003/94/EC

The Organisation for Professionals in Regulatory Affairs

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The legal duties of the IMP QP

• If equivalent GMP cannot be obtained – each batch has undergone all relevant analysis, tests and checks to confirm its quality.

• The QP must certify in a register or equivalent.

• Presently the only legal duty in the new CT Regulation 536/2014 is to ensure compliance with GMP. Omissions have been addressed in the new IMP GMP legislation and guidance.

The Organisation for Professionals in Regulatory Affairs

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