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.
Validation Dept by filling out aValidation Project Log Form(Form-375). 5.2.2. The Validation Dept is responsible for allocating a unique Project No. to each Project. The same code number will be utilised for the numbering of associated documentation relating to that Validation file e.g. Validation plan, IQ, Qualification
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