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Dynamic Pharma Team

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Why Validation?

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;

Increased throughput

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

Pharmaceutical Guideline


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