control strategy
- Guideline or reference source
- ICHM7 Assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- ICHQ10 Pharmaceutical quality system
- ICHQ11 Development and manufacture of drug substances
- ICHQ3D Guideline for elemental impurities
- Definition
- A planned set of controls, derived from current product and process understanding, which assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.
- Related Term
- process performance qualification
- quality control
- state of control
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