Module 5 Presentations

18/07/2024

Further Legislation changes:

• EC has now adopted new GMP for IMP Regulation (2017/1569) effective from 01 April 2018 which addresses the missing QP duties in the CT Regulation • EC have also adopted a new Directive GMP for Medicinal Products for Human Use (2017/1572) to replace 2003/94 removing all mention of IMP. This Directive has been effective from 31 March 2018

So……. CT Directive 2001/20 GMP Directive 2003/94

Annex 13 to be revised

The Organisation for Professionals in Regulatory Affairs

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Directive 2003/94/EC

• Manufacture in accordance with CTA (IMPD) • Training on IMPs in particular • Document Retention – 5 years after completion or discontinuation of study • Validation should be appropriate to the stage of development but critical steps e.g. sterilisation, should be validated • IMPs imported from third countries -analytical control not mandatory • Retention samples – 2 years after completion/discontinuation of study • Complaints/recall of comparators - ensure that system in place • Mechanism for rapid un-blinding

The Organisation for Professionals in Regulatory Affairs

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