A representative certificate documents a batch that is not the one in front of you. It may have been synthesised months earlier, from different starting material, on a different column. It carries no information about the vial in your hand.
Traceability is the discipline of binding a physical unit to its own record: a lot number on the vial, the same lot number on the certificate, and an unbroken chain back to the synthesis and the analytical run.
The underlying principle is not novel — it is the same one that governs quality management systems generally, where identification and traceability of product is an explicit requirement rather than a courtesy.
Research Status
A quality-systems standard, not a clinical evidence question -- ISO and WHO guidance define the expected practice.
Selected Research
- ISO. ISO 9001 — Quality Management Systems. International Organization for Standardization, 2015.
- World Health Organization. WHO Good Manufacturing Practices guidance. WHO Norms and Standards for Pharmaceuticals, 2024.
Related Research