Definition of Validation Protocol

By Katina Blue, eHow Contributor

updated: September 11, 2010

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Validation protocol ensures that specific procedures are followed correctly.

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Validation protocol is a means of testing a process to ensure its effectiveness or validity. It helps businesses and other organizations reach specific goals through tests and examinations.

Purpose

1. Validation protocol helps determine whether certain rules or procedures are being done correctly. It employs specific instructions or guidelines that must be followed to accomplish an end result.

Example

2. Businesses use validation protocol for various reasons, including evaluating the final construction of a product. For instance, an auto manufacturing plant could devise certain guidelines and tests to measure how well employees are assembling parts. The tests would evaluate how the part is constructed from beginning to end based on the given set of rules. The use of tests to measure the success of an outcome, such as a properly crafted auto part, is a form of validation protocol.

Benefits

3. Validation protocol is useful for businesses, universities, hospitals and any other entities that need to attain specific goals. It helps companies and individuals assess if products are created according to standards. It also aids in ensuring that the desired outcome of a procedure is achieved.

Definition of Process Validation

Process validation is important to a wide range of industries, particularly that of pharmaceutical production. Without process validation, manufactured products would be both inconsistent and substandard.

Definition

1. Process validation is a procedure used to ensure that a certain process produces consistent, desirable results over a period of time. It guarantees that a given method for making products allows them to meet predetermined standards in a cost-effective way.

Areas Inspected

2. When a process undergoes validation, inspectors begin by checking to see that the equipment used in the process operates properly. Then, they check the results to make sure they fully meet quality standards. Finally, they observe the process over a period of time to ensure that the results are consistent.

Results

3. After observing these three areas, professionals compare the results to see if they match up with a predetermined set of standards. The process is then either validated or adjusted to make it fit the company's requirements.

Pharmaceuticals

4. Process validation is especially important to the pharmaceutical industry, because drug companies must be certain that their products are consistently identical. Because of this, the FDA strictly regulates process validation in this area.