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. Allvalidation documentation is prepared and maintained to be readily accessible to Operationspersonnel.
Standard Operating Procedures (SOPs), manufacturing formulae, detailed batch documentation, change control systems, investigational reporting systems, analytical documentation, development reports, validation protocols and reports are integral componentsof the validation philosophy.
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