Before preparation
Confirm the lot, review the COA, verify storage history, and check that the working area and required materials are ready before beginning. Unclear documentation should be resolved first.
Reconstitution workflow notes for lab handling, calculations, and records.
This guide focuses on process: checking source documents, verifying concentration inputs, using sterile workflow, and recording prepared material internally.
Calculation checks
Check the vial amount, target working concentration, and lab volume assumptions before preparation. Use a documented calculator or internal worksheet and have another person verify inputs where practical.
Use the calculator carefully A calculator saves time, but the source values still need manual verification against the label and record set.
Labels and dating
After preparation, internal labels should record lot, preparation date, concentration, preparer, and any internal storage note required by the lab process.
Record retention
Keep the calculation sheet or calculator output with the batch file. If the material is subdivided, record each movement and retain the link back to the original lot.