Module 3 2019

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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