CRED Getting the CMC Dossier Right 2024

28/08/2024

Validated Methods

Directive 2001/83 (Annex 1 – Part 1 (3.2 (4)):

All the procedures and methods used for manufacturing and controlling the active substance and the finished medicinal product shall be described in sufficient details to enable them to be repeated in control tests, carried out at the request of the competent authority. All test procedures shall correspond to the state of scientific progress at the time and shall be validated. Results of the validation studies shall be provided. In the case of test procedures included in the European Pharmacopoeia, this description shall be replaced by the appropriate detailed reference to the monograph(s) and general chapter(s).

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Reference standards

API Reference standards are used to help ensure the identity, potency, quality and purity of drug products and drug substances Reference standard = Highly purified compound that is fully characterised and purity defined

Evidence of structure and physico-chemical form;

● IR/NMR/UV

● Elemental analysis

● Mass spec

● Polymorphism (XRPD/MP)

● Stereochemistry (optical rotation, chiral chromatography)

All sources of impurities quantified

Periodically re-qualified and supply controlled

The Organisation for Professionals in Regulatory Affairs

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