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
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
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)
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control, engineering
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