cGMP Starting Materials (Regulatory or Registered Starting Materials, ‘RSMs’) represent the formal start of cGMP (current Good Manufacturing Practice) control, and potential start of validation for a given Drug Substance/Active Pharmaceutical Ingredient (API) manufacturing process.
This highlight article outlines main selection factors described in ICH Q11 and Q&A guides, and presents several examples of their application.
Key selection factors include:
- Placement in the overall synthesis, including separation from common reagents and from the Drug Substance
- Material characterization, analytical and stability knowledge
- Impurity profile and management, in particular of high risk impurities (e.g. DNA-reactive impurities or nitrosamines)
- Specification tests and criteria, and contribution to overall control strategy
- Source selection and manufacturing controls, including knowledge and management of process and process changes
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