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By Kaira G. Tafoya
Validation is a systematic approach to gathering and analyzing sufficient data which will give reasonable assurance (documented evidence), based upon scientific judgment, that a process, when operating within specified parameters, will consistently produce results within predetermined specifications. It is an action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result. It is a 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 and characteristics. It is used as obtaining and documenting evidence to demonstrate that a method can be relied upon to produce the intended result within defined limits.

The minimum requirements of method validation are discussed below. In the case of methods developed from scratch in-house a much more comprehensive approach covering the other parameters described below will be required. Few laboratories, however, take this approach and the norm is to adopt and perhaps slightly modify standard methods.

Precision is the measure of the degree of repeat ability of an analytical method under normal operation and is normally expressed as the percent relative standard deviation for a statistically significant number of samples. The two most common precision measures are ‘repeat-ability’ and ‘reproducibility’. These are expression of two extreme measure of precision which can be obtained. Repeatability (the smallest expected precision) will give an idea of the sort of variability to be expected when a method is performed by a single analyst on one piece of equipment over a short time scale. If a sample is analyzed by a number of laboratories for comparative purposes then a more meaningful precision measure to use is reproducibility (this is the largest measure of precision). In practice the laboratory is usually interested in the extent of variability which occurs over time when it operates the method. This is called ‘intermediate precision’ and describes the variability when the method is deployed in the same laboratory, perhaps on different pieces of equipment, and using different analysts on the staff. It is expected that this will give a value between repeatability and reproducibility.

There are several important features of Validation like Increased throughput, reduction in rejections and reworking, reduction in utility costs, avoidance of capital expenditures, fewer complaints about process-related failures, reduced testing in-process and in finished goods, more rapid and reliable start-up of new equipment, easier scale-up from development work, easier maintenance of equipment, improved employee awareness of processes and more rapid automation.

Since the mid-1970s validation has become an increasingly dominant influence in the manufacture and quality assurance of pharmaceutical products. In 1976 the FDA proposed a whole set of current GMP regulations which were revised several times. In several major countries GMP regulations are considered official law and noncompliance is prosecutable. Additional compliance policies, guides, and guidelines are not legally binding. However, the pharmaceutical industry follows them as a part of good management and business practice. The demands in the health care industry are greater than ever because customers (government, physicians, pharmacists, patients, and health insurance companies) are more interested in product safety, efficacy, and potency and asking value for money. Pharmaceutical products’ quality must be consistent and meet the health and regulatory requirements. The pharmaceutical industry has the obligation to validate GMP to their process to be in compliance with GMP requirements.

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