Transcription of Validation-Concept and Procedure - GMPSOP
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Validation-Concept and Procedure - GMPSOP
Standard Operating ProcedureTitle: validation concept and Procedure_____Copyright All rights reservedUnauthorized copying, publishing, transmission and distribution of any part of the content by electronicmeans are strictly Criteria Successful Master of of ValidationAccording to GMP definitionValidation is Establishing documented evidence which provides a highdegree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. Appropriate and complete documentation is recognised as being crucial to the validation Operating procedures (SOPs), manufacturing formulae, detailed batch documentation,change control systems, investigational reporting systems, analytical documentation, developmentreports, validation protocols and reports are integral componentsof the validation philosophy.
5.1.1. All Validation Documents are to be clearly identified with numbered pages, with clear units of measure stated, results/signatures recorded in black or blue pen, and signatures of persons performing tests and dates conducted are all to be captured. 5.1.2. The original copies of approved Validation documents are the responsibility of the
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