Research use only. This page explains laboratory concepts for scientific education. It is not a clinical procedure, administration protocol, human-use instruction, veterinary-use instruction, or consumer protocol.
Overview
Chain of custody is the documented record of material possession, transfer, handling, and storage context.
Purpose
The purpose is to explain how custody records support traceability and reviewability.
Scientific Background
Chain-of-custody concepts are used across laboratory and analytical environments to maintain a documented material history.
Laboratory Considerations
- Identify who or what system held the material at each stage.
- Document transfer points when relevant.
- Connect custody notes to lot identifiers.
Quality Considerations
Custody records support confidence in record continuity but do not independently establish analytical quality.
Documentation Standards
Useful custody records may include dates, responsible parties or systems, storage state, and transfer notes.
Common Misconceptions
- Custody is not the same as purity.
- Custody records do not replace COA review.
- This concept is not a human-use procedure.
References
Quality Reference
ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories.
Analytical Reference
ICH Q2(R2). Validation of Analytical Procedures. International Council for Harmonisation. 2023.
Research Use Only Statement
Apex Molecular Labs Laboratory Standards pages are provided for scientific and laboratory education only. They do not provide medical advice, clinical procedures, treatment guidance, administration instructions, consumer protocols, human-use instructions, veterinary guidance, or therapeutic recommendations.
