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Standard Operating Procedure

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Standard Operating Procedure Title: Deviation Report System ________________________________________ ________________________________________ ______ Copyright All rights reserved Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited. Page 1 of 17 Document Owner Quality Assurance Manager Affected Parties All Site colleagues Purpose To define the procedures to be followed and the responsibility for raising and documenting Deviation Report (DR) where material/product or process do not comply with organization/regulatory requirements. NOTE: The aim is to segregate product linked with a Quality concern, determine the root cause, assign Corrective Action responsibilities, and whenever possible, actions that lead to prevention.

Standard Operating Procedure ... To define the procedures to be followed and the responsibility for raising and documenting Deviation Report ... QA manager should review the data for potential impact to the product quality, validation and regulatory requirement. If satisfactory approve the deviation report.

  Operating, Standards, Data, Validation, Procedures, Standard operating

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