API and pharmaceutical intermediate sourcing requires more than a price comparison. Procurement, quality and technical teams should jointly assess the legal entity, manufacturing site, quality controls, process capabilities and continuity of supply.
Confirm the contracting entity, actual manufacturer, site address and responsible contacts. Review relevant business, manufacturing and qualification documents.
Align on product name, CAS number, specification, critical impurities, analytical methods, batch scale, packaging and storage. Custom projects also require route and scale-up evaluation.
Depending on the project stage, review the COA, MSDS, specification, analytical methods and other necessary documents, together with change and traceability arrangements.
Evaluate key raw materials, capacity, lead time, contingency plans and EHS controls. Hazardous processes and special transport conditions require early risk assessment.
Define technical and commercial contacts for sample, validation and commercial stages, document agreements and periodically review quality and delivery performance.
