The CoA should document the original manufacturer to support traceability throughout the supply chain
[ICH Q7, Sections 11.4, 17.6]. The original manufacturer would be the facility where the final purified API/intermediate is produced. Further physical processing (e.g., drying, micronisation, milling, sieving) of an API would not make the manufacturer performing such operations the original manufacturer. All authentic CoAs including those of the original manufacturer should be available [ICH Q7, Section 17.20].
