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.

Critical suppliers are assessed and managed according to risk.

Unique batch numbers are assigned to raw materials, packaging materials and shipping containers; controlled records are maintained for label printing, issuance, return and destruction.

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.