How to Qualify API, Excipient, and Service Providers in Pharma: Vendor Audits, Documentation & Risk Classification Step-by-Step Guide to Qualifying API, Excipient, and Service Providers in Pharma In pharmaceutical manufacturing, the quality of the final product begins with the quality of incoming materials and services. APIs, excipients, packaging components, contract laboratories, and logistics providers all contribute to the safety, efficacy, and regulatory compliance of the product. Therefore, the selection and qualification of vendors are governed by strict FDA, EMA, and ICH requirements. This article provides a detailed, actionable framework for vendor qualification covering raw material suppliers (APIs, excipients) and service…