Quality Management Plan (QMP) — GLPI103-301 Program
| Field | Value |
|---|---|
| Document ID | QA-QMP |
| Version | 1.0 |
| Standard | ICH E6(R3) (Quality by Design); ICH Q9 (Quality Risk Management) |
| Confidentiality | Confidential |
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Quality Assurance | Initial QMP |
1. Quality Approach
Quality by Design (QbD) per ICH E6(R3): identify factors critical to quality (participant safety, data reliability), focus controls there, and manage risk proportionately (ICH Q9).
2. Critical-to-Quality Factors
Informed consent; eligibility integrity; randomization/blinding; primary-endpoint data integrity; SAE/AESI capture and reporting; CDISC data standardization and traceability.
3. Risk Management & QTLs
Quality Tolerance Limits and Key Risk Indicators are defined in the Clinical Monitoring Plan (TMF-CMP); excursions trigger root-cause analysis and CAPA (QA-ISSUE).
4. Roles & Governance
QA independent of operations; the Steering Committee (PM-005) provides governance; vendor oversight per PM-006.
5. Issue & Deviation Management
Protocol deviations are logged (QA-DEV) and categorized (major/minor); issues/CAPA are tracked to closure (QA-ISSUE); governance decisions are recorded (PM-DECISION).
6. Automated Quality Controls (this project)
Reproducible build (build.py) and three verification gates — verify_pipeline.py (25 checks), validate_cdisc.py (CDISC conformance), reconcile_csr.py (document↔data) — provide objective, repeatable quality evidence (QC-001).
7. Audit & Inspection Readiness
Internal audits and inspection-readiness activities are planned (records not generated for this portfolio).