The origins of validation in the global healthcare industry can be traced to terminal sterilization process failures in the early 1970s. Individuals in the United States point to the LVP sterilization problems of Abbott and Baxter, while those in the U.K. cite the Davenport incident.
Each incident was a result of a non-obvious fault coupled with the inherent limitations of the end-product sterility test. As a consequence of these events, non-sterile materials were released to the market, deaths occurred, and regulatory investigations were launched. The outcome of this was the introduction by the regulators of the concept of “Validation”:
Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes
First, and certainly foremost, among the reasons for validation is that it is a regulatory requirement for virtually every process in the global health care industry for pharmaceuticals, biologics, and medical devices.
Regulatory agencies across the world expect firms to validate their processes. The continuing trend toward harmonization of requirements will eventually result in a common level of expectation for validations worldwide.
Some tangible and intangible benefits of validation are as follows;
Reduction in rejections and reworks
Reduction in utility costs
Avoidance of capital expenditures
Fewer complaints about process-related failures
Reduced testing process and finished goods
More rapid and accurate investigations into process deviations
More rapid and reliable startup of new equipment
Easier scale-up from development work
Easier maintenance of the equipment
Improved employee awareness of processes
More rapid automation