Standard Operating Procedure (SOP) – Validation: Concept and Procedure

1.0 Purpose This SOP defines the validation process, encompassing the philosophy, responsibilities, procedures, documentation requirements, and revalidation program, to ensure consistent production of products meeting pre-determined specifications and quality attributes. 2.0 Scope This SOP applies to all validation activities related to new and existing equipment, processes, and systems within the manufacturing facility. 3.0 Definitions Validation: Establishing documented evidence that provides […]