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.


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


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


Table of contents

Report certification


Manufacturing schedule

Validation Procedure (details of input material, environmental conditions, manufacturing details etc.,).

Reference documents, analytical results.



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


Master copy –  Quality Assurance

Controlled copies- Quality Assurance, Production, Quality Control, engineering


Date Revision Number Reason for Revision
00 New SOP

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