ABSTRACT

The protocol specifies the validation strategy being used, the product grouping being validated, the bioburden data obtained upon which the verification dose is selected, and the support testing to be performed. There are many methods and approaches to validation that are scientifically sound, but it has become commonplace for the validation effort to be broken into segments: installation qualification, operational qualification, performance qualification, and requalification. The protocol should have sufficient details so that there is no misunderstanding about the testing required for performance of a successful validation. The protocol should be reviewed and approved by qualified personnel from the validation team composed of representatives from the quality, engineering, and operations groups prior to initiating the validation as well as the quality or validation specialist at the selected contract sterilizer. The elements of the protocol are as follows: objective, scope, definitions, responsibilities, equipment/materials, procedure, acceptance criteria, requalification, approvals, references and attachments.