ICH Q10 PQS applies across 4 product lifecycle stages with stage-specific quality system elements. Stage 1 Pharmaceutical Development: covers drug substance and drug product development + formulation + analytical method development + process development + scale-up + clinical trial supplies; ICH Q8 (Pharmaceutical Development) + Q11 (Development and Manufacture of Drug Substances) + Q14 (Analytical Procedure Development) + QbD concepts (Quality Target Product Profile QTPP + Critical Quality Attributes CQAs + Critical Process Parameters CPPs + design space + control strategy); ICH M11 CESHARP clinical study harmonised protocol. Stage 2 Technology Transfer: transfer from development to manufacturing (originator) and between manufacturing sites (post-approval); supports knowledge management + transferring process understanding + controls + analytical methods; technology transfer protocol + master technology transfer report + receiver site qualification + comparability testing + process validation + variations submission. Stage 3 Commercial Manufacturing: routine production + product release + supply chain + ongoing process verification (OPV - Stage 3 process validation continued process verification) + stability monitoring + complaint handling + supplier management + product quality review (PQR) + Annual Product Quality Review (APQR); state of control maintained. Stage 4 Product Discontinuation: planned discontinuation includes regulatory notification (variation + withdrawal) + commitment fulfilment + supply continuity to existing patients + retention of records + final stability + complaints handling + recall procedures + transfer to alternate supplier if applicable; unplanned discontinuation (supply disruption + safety + commercial). Each stage incorporates Knowledge Management + QRM + Section 2 Mgmt Responsibility + Section 3 Continual Improvement. Coordinates with FDA Process Validation Stages 1-3 (Process Design + Qualification + Continued Verification) + EU GMP Annex 15 + ICH Q12 (Lifecycle Management) + 21 CFR Part 314.81 (Annual Report) + 314.70 (Supplements). ICH Q10 + 4 Lifecycle Stages + State of Control applies.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.