Validation (drug manufacture)

Validation (drug manufacture)

Validation in the context of drug manufacture refers to the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies the specified requirements. Pronunciation: /ˌvalɪˈdeɪʃ(ə)n/

Etymology

The term 'validation' originates from the Latin word 'validus' which means strong or effective. The term was first used in the context of drug manufacture in the 1970s.

Definition

In pharmaceutical industry, validation is a formal and systematic way to demonstrate the suitability of the drug manufacturing process, ensuring products are consistently produced and controlled according to quality standards. It involves a series of activities taking place over the lifecycle of the product and process. This concept is widely applied in all stages of drug manufacture, from the initial production to the final product.

Types of Validation

There are several types of validation in drug manufacture, including:

• Process Validation: Ensuring that the process produces the desired results consistently.
• Analytical Method Validation: Verifying that the analytical method is suitable for its intended purpose.
• Cleaning Validation: Ensuring that the cleaning process removes residues of the product being manufactured.
• Computer System Validation: Ensuring that the computer system works as intended in a consistent manner.

Related Terms

• Qualification: The act of proving that any equipment works correctly and actually leads to the expected results.
• Good Manufacturing Practice (GMP): A system for ensuring that products are consistently produced and controlled according to quality standards.
• Quality Assurance (QA): The maintenance of a desired level of quality in a service or product.

See Also

• Pharmaceutical Quality System
• Quality Control in Pharmaceutical Industry

External links

• Medical encyclopedia article on Validation (drug manufacture)
• Wikipedia's article - Validation (drug manufacture)

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