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SOP on Process Validation Programmed in Pharmaceutical Company

SOP on Process Validation Programmed in Pharmaceutical Company

  • 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.
  • 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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