Go back

Qdossier Qsauri
"C"

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
 

Send comments to info@qdossier.com Please read disclaimer before using Qsauri.