SOP on Process Validation Programmed in Pharmaceutical Company

SOP on Process Validation Programmed in Pharmaceutical Company

• OBJECTIVE :
• To lay down the procedure for the process validation of products to ensure that a specific process will consistently produce the product meeting its pre-determined specifications and quality attributes.
• RESPONSIBILITY :
• Research  Development to prepare and execute the validation protocol and to prepare a final report on Process Validation.
• Production to execute the manufacturing of the batches alongwith Research & Development.
• Quality Control to analyse the samples and report the results.
• Quality Assurance to review the protocol for its adequacy and completeness, to sample as per validation protocol and to review analytical results.
• Validation committee, consisting of Heads of R&D, Production, Quality Control and Quality Assurance, to review, approve the protocol and certify the final reports.
• Validation department to co-ordinate the entire activity of validation.
• Procedure
• All  the  equipments / systems / facilities  to be  used  during the process validation shall be qualified.
• In  general, a  minimum of  three (3) consecutive commercial batches shall be taken for process validation.
• Process validation for a product shall include the challenging of the process parameters.
• Validation  batches can  be released for distribution after the validation data has been reviewed and found acceptable by the validation committee.
• The  process  validation  protocol should be written and approved prior to manufacturing.
• A typical validation protocol may consist of the following
• Title of the study
• Protocol Approvals
• Objective
• Reference document
• Product / process description
• Process flow diagrams
• Manufacturing equipment qualification summary
• Sampling Test Plan
• Stability studies requirements
• Validation protocol attachments
• Sampling diagram of equipments where ever applicable.
• A validation report shall be prepared upon the completion of the study and may consist of the following
• Title
• Table of contents
• Report certification
• Abstract
• Manufacturing schedule
• Validation Procedure (details of input material, environmental conditions, manufacturing details etc.,).
• Reference documents, analytical results.
• Summary
• Annexures
• A product/process will be considered validated, when 3 consecutive commercial scale batches meet the acceptance criteria established in the validation protocol.
• If a batch fails to meet acceptance criteria,  investigation of the cause of failure must be conducted and corrective action will be implemented.
• Validated  systems / equipments / process  are  considered  to  be in a state  of  control.  As long as  conditions  and  control  parameters remain unchanged, they continue in  their  validated state.  Any  changes  shall be handled through a “change control programme”.  The changes will be  reviewed as per the “change control programme”.
• Validation batches shall be subjected to stability studies.

• Forms and Records (Annexures)
• Not Applicable

• Distribution
• Master copy –  Quality Assurance
• Controlled copies- Quality Assurance, Production, Quality Control.engineering
• History
  

  Date	Revision Number	Reason for Revision
  –	00	New SOP

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