Stage 3 · Toolkit 3.8
IMP Packaging, Labelling & Distribution
Control IMP packaging, labelling, inventory, distribution, custody, and temperature excursions.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for IMP Packaging, Labelling & Distribution.
How it helps your team
Keep CMC evidence, changes, and release decisions visible as development moves forward.
Designed for
CMC, Pharmaceutical Development, Manufacturing, Quality, Supply Chain, and Regulatory Affairs teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- IMP Packaging & Labelling SOP
- IMP Label Review Checklist
- Clinical Supply Distribution Plan
- Temperature Excursion Assessment Template
- Chain of Custody Template
- IMP Distribution Decision Memo
Excel workbooks
- IMP Inventory Tracker
- Distribution Tracker
- Temperature Excursion Log
- Label Approval Tracker
- Site Supply Tracker
- Chain of Custody Tracker
Related toolkits
Continue within stage 3
CMC Development & Regulatory Readiness
Govern CMC development, evidence readiness, and regulatory preparation.
3.2Drug Substance Development & Control Strategy
Define drug substance development, process controls, impurities, CQAs, and CPPs.
3.3Drug Product / Formulation Development
Define formulation, excipient, container closure, and drug product control strategy.