Understanding the problems in pharmaceutical procurement with special reference to active pharmaceutical ingredients and excipients

Abstract

Procurement of raw materials, key intermediates and excipients for the preparation of finished pharmaceutical preparation is considered to be complex process which involve multiple channels and require skilled personnel and proper validation. This review attempts, in relatively brief compass to provide an account of the problems that arise while procurement of active pharmaceutical ingredient (API) and excipients in pharmaceutical industry. This review has been structured with specified as well as generalized problems raised up during procurement of API and other material in pharmaceutical industry. Lack of proper regulatory requirements and unbiased market information with the absence of a comprehensive procurement policy is the major factor which creates complications while procurement. Besides these, lack of properly designed user requirement specifications (URS) which ultimately affect quality and delivery of quoted material. An 8-Question-based approach has been proposed to design URS, other approaches for material procurement and supplier qualification have been discussed, and a vendor certification procedure is presented.