What is Validation, and Why Validate

Validation itself is considered a required part of good laboratory practice (GLP) and good manufacturing practice (GMP) within any pharmaceutical laboratory and has been defined by the FDA as  

Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes —FDA Guidelines on General Principles of Process Validation, May 1987. 

In a pharmaceutical laboratory environment, system validation for analytical instrumentation is certainly both a value and a burden. Albeit a valuable procedure, it is a process that requires considerable time and resource expenditure. Part of the latter concern is exacerbated by the fact that many laboratories are not quite sure about what exactly is required. In this chapter, the system validation terms will be defined, the responsibilities and requirements will be brought into better focus and recommended procedures will be described. This is intended to help relieve the actual burden of the process for those on-site individuals who are directly involved with the drafting and implementation of the validation procedures. The recommendations herein are provided as guidance to help streamline the actual procedures in an effort to keep both the time and financial expenditures to a minimum. 

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