Traceability Policy
Full life-cycle coverage
A complete “supplier – manufacturing – testing – shipment – customer” chain record must be established for every batch, starting from raw materials (including intermediates, solvents, catalysts) to the finished API.
Tiered supplier management
Critical suppliers are assessed and managed according to risk.
Dual control of records & identification
Unique batch numbers are assigned to raw materials, packaging materials and shipping containers; controlled records are maintained for label printing, issuance, return and destruction.
Integrated recall & deviation response
Upon any quality event, the implicated raw-material batch can be locked, traced back to the upstream supplier and forward to downstream customers, and a recall can be initiated when necessary.
Traceability Objectives
01
Traceability timeliness
02
Record completeness
03
Supplier transparency
04
Audit coverage
05
System validation
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