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RESPONSIBILITY
It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance.
PROCEDURE
1. Definition of Validation
Validation is a systematic approach to gathering and analyzing sufficient data which will give reasonable assurance (documented evidence), based upon scientific judgment, that a process, when operating within specified parameters, will consistently produce results within predetermined specifications.
2. Type of Validation
Retrospective Validation Prospective Validation Concurrent Validation Revalidation
2.4 Revalidation
To validate change in equipment, packaging, formulation operating procedure, or process that could impact product safety, efficacy, or potency. It is important to establish a revalidation program for critical equipment to maintain validity.
3. Importance of Validation
Increased throughput Reduction in rejections and reworking Reduction in utility costs Avoidance of capital expenditures Fewer complaints about process-related failures Reduced testing in-process and in finished goods More rapid and reliable start-up of new equipment Easier scale-up from development work Easier maintenance of equipment Improved employee awareness of processes More rapid automation