Definition of validating
Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.Process validation involves a series of activities taking place over the lifecycle of the product and process. The Process validation activities can be described in three stages.This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems.Data validation is a process that ensures the delivery of clean and clear data to the programs, applications and services using it.This approach to validation is normally undertaken whenever the process for a new formula (or within a new facility) must be validated before routine pharmaceutical production commences.In fact, validation of a process by this approach often leads to transfer of the manufacturing process from the development function to production.Philosophers of science are concerned with valid ways of knowing and ways of validating that which is known.
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Process validation is the verification that a process meets the requirements imposed on its process results.
Learn when you must validate which processes (in the context of software) and how to ace validation.
Retrospective validation is used for facilities, processes, and process controls in operation use that have not undergone a formally documented validation process.
Validation of these facilities, processes, and process controls is possible using historical data to provide the necessary documentary evidence that the process is doing what it is believed to do.