Validation as a Best Practice - Part 1

Written by Scott Collins - Senior Validation Manager, QPharma 

 The Life Sciences industry understands validation as a regulatory requirement.  It is a process completed because regulatory agencies, such as the Food and Drug Administration (FDA), require it.  Most companies even have internal quality procedures that require validation before a piece of equipment, system, or process can be placed into routine operation.  I am still amazed by how many groups perform validation simply because it is a requirement.  When validation is performed with this as the only driver, the value and benefits of validation can be missed.

The definition of validation is documented evidence that a piece of equipment, system, or process consistently produces a product that meets its predetermined specifications (see slides 4 and 5 of this linked presentation for more definitions).  The definition implies that you know the end result that you are trying to obtain before you initiate the validation effort.  I often see groups using validation as a discovery or troubleshooting activity.  They do not understand the full scope and intended use of the equipment, system, or process before starting validation.

An adequate, full validation life cycle process requires the business or process owner to thoroughly understand the equipment, system, or process before they start the validation studies.  They must have a clear concise plan, testable user requirements, adequate design documentation, and detailed test protocols with expected results.  From a product quality perspective, validation demonstrates control over the manufacturing process, thereby increasing product quality, while minimizing risk to the customer.  From a business perspective this approach allows for maximum efficiency, minimum waste, and maximum profit.  These are the reasons why validation should be the best practice for any company. 

Follow the link below for Part 1 of the presentation Validation as a Best Practice for more information. Register or sign in and head to "Media", and then "Whitepapers": http://www.qpharmacorp.com/whitepapers