ICH Q10 Pharmaceutical Quality System (PQS) - ICH Harmonised Tripartite Guideline (Current Step 4 version dated 4 June 2008). Provides a model for an effective quality management system for the pharmaceutical industry covering the product lifecycle. Three main objectives: achieve product realisation + establish and maintain a state of control + facilitate continual improvement. The guideline applies to the full product lifecycle from pharmaceutical development through commercial manufacturing to product discontinuation - covering active pharmaceutical ingredients (API) + drug products + biological products + biotechnological products. ICH Q10 is intentionally aligned with ISO 9001 quality management system concepts and complements GMP regional requirements (FDA 21 CFR Part 210/211 + EU EudraLex Volume 4 + PMDA GMP). Coordinates with ICH Q8 (Pharmaceutical Development - quality by design QbD + design space + control strategy + critical quality attributes CQAs); ICH Q9 (Quality Risk Management - risk identification + analysis + evaluation + control + review + risk-based decision-making); ICH Q11 (Development and Manufacture of Drug Substances); ICH Q12 (Lifecycle Management - established conditions + post-approval change management); ICH Q13 (Continuous Manufacturing); ICH Q14 (Analytical Procedure Development). Implementation by FDA (CDER + CBER + ORA) + EMA (CHMP + CMDh) + PMDA + Health Canada + Swissmedic + ANVISA + NMPA China + CDSCO India + WHO Prequalification. Q10 PQS = ICH Q8 + Q9 + Q10 trinity (Quality by Design + Risk Management + Quality System). The guideline is freely distributable + public ICH publication. ICH Q10 + Scope + PQS + ICH family + ISO 9001 + GMP coordination applies.
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