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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