CRED Getting the CMC Dossier Right 2024

29/08/2024

GMP & Inspections

⚫ Increased focus on GMP for Drug Substances - ICH:

● Q7 (GMP Guide for APIs)

● Q9 (Quality Risk Management)

● Q10 (Pharmaceutical Quality System)

● Q11 (development/manufacture of DS) – requires all steps from synthesis Starting Materials (as described in MAA) onwards to be performed under cGMP

⚫ EU-GMP certificates required for sterile DS

● MRAs ; Does not replace QP declaration

⚫ QP declaration required for all DS

● Confirms that the API is manufactured in compliance with GMP

● All BR sites covered? All ASM sites covered? Dates of the last audit? Who performed audits?

● EMA Declaration template: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/01/WC500100727.pdf

● Guidance: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/06/WC500167852.pdf

The Organisation for Professionals in Regulatory Affairs

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EU Falsified Medicines Legislation

⚫ Falsified Medicines Directive (FMD) 2011/62/EU

● https://ec.europa.eu/health/human-use/falsified_medicines_en

⚫ 4 Pillars

Active Substances

GDP

Internet sales

Safety Features

Objective: strengthen obligations and supervision – Registration of EU manufactures, importers and distributors of Active substances to be included in EU database – Manufacturing authorisation holder (MAH) legally obliged to audit (or have audited on its behalf) manufacturers and distributors of Active Substances used. – Applicant for marketing authorisation is required to submit a written statement from the competent authority of the exporting country confirming that the Active substance used is manufactured in accordance with Good Manufacturing Practice ( GMP ) Useful information re FMD (esp. safety features/supply chain): MHRA Inspectorate blog, e.g. https://mhrainspectorate.blog.gov.uk/2019/02/08/falsified-medicines-directive-safety-features/

The Organisation for Professionals in Regulatory Affairs

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