Compliance Risk Management Using a Top-Down Validation Approach

Validation has been an established fact of life within the pharmaceutical and healthcare industries since the mid-1970s. It has evolved from a poorly understood concept into a major source of difficulty for manufacturers. Initially conceived in response to specific sterility problems in the large-volume parenteral industry, it has morphed into a broad-based regulatory expectation for a myriad of activities.

In the healthcare industry, the difficulties associated with validation have much to do with its origins. Validation in the pharmaceutical industry was imposed on the pharmaceutical industry by regulators as an appropriate means to establish the sterility of large-volume parenterals where the earlier control methods had proved inadequate (1). Because it was first associated with the preparation of sterile materials, validation has always been pursued with a near-absolutist mentality in all aspects. It has never been considered a valuable activity, likely because of its regulatory origins, but one that is largely associated with maintaining compliance.