ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance 6 Control Strategy General Principles (cont'd) A control strategy can include, but is not limited to: Controls on material attributes (including raw materials, starting materials, intermediates, reagents, primary packaging materials for the drug substance, etc) ■ Controls implicit in the design of the manufacturing process (e.g., sequence of purification steps (biotech) or order of addition of reagents (chem)) In-process controls (including in-process tests and process parameters) ■ Controls on drug substance (e.g., release testing) March 2012 ICI+ Slide 27

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