Batch Release & Traceability
What it is
The documented decision to release a manufactured lot for sale.
How it works
A lot is released only when it meets specification; lot-level traceability links each device back to its raw materials and process records.
Why it matters
Release criteria and traceability support recalls, audits and regulatory compliance.
Key components
- Release criteria
- Lot records
- Raw-material traceability
Applications
- Documented release of a manufactured lot
- Lot-level traceability for recalls and audits
What affects performance
- Release criteria
- Lot record completeness
- Raw-material traceability
Limitations
- Release criteria must be pre-defined
- Traceability depends on record-keeping
Common failure modes
- Incomplete lot records
- Traceability gaps from raw material to device
- Release without defined criteria
Frequently Asked Questions
What is batch release? The documented decision to release a lot after it meets specification and traceability requirements.
Related knowledge
References
- Posthuma-Trumpie GA, Korf J, van Amerongen A. Lateral flow (immuno)assay: its strengths, weaknesses, opportunities and threats. Anal Bioanal Chem. 2009;393(2):569-582.
- 胶体金免疫层析法定性检测试剂技术审评要点（NMPA technical review）. ivdmat.com.
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Written by the Progene Bio Technical Team · Last reviewed: 2026-09-12