Quality Management Plan (QMP) — GLPI103-301 Program
📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The Quality Management Plan — how quality is designed into and assured across the program.
Why it exists. Quality-by-design (ICH E6(R3), Q9) asks sponsors to build quality into trials proactively. The QMP defines the quality system, critical-to-quality factors, and how issues are prevented and caught.
How it is produced here. It is a quality record: a plan or log that shows how the program controls quality and builds the audit trail sitting behind every other document.
Format & governing standard. ICH E6(R3) (Quality by Design); ICH Q9 (Quality Risk Management)
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).
Comments (0)
No comments yet. Be the first to say something!