Module 3 Presentations

14/05/2024

Starting Materials

 Need to robust scientific argument to define regulatory starting materials (RSM) to know where GMP controls begin o Scientific advice is critical to avoid nasty surprises  No clear definition from authorities but ICH provides some help (next slide) and choice is a balance of perceived added quality against certain increased costs (staff, plant, testing, GMP)  Note that EU and US views on same synthesis may define different RSM compounds

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Starting Material: ICH Q11 Definition  An “Active Substance Starting Material” is a raw material, intermediate, or an active substance that is used in the production of an active substance and that is incorporated as a significant structural fragment into the structure of the active substance. An Active Substance Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house . Active Substance Starting Materials normally have defined chemical properties and structure .

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