1.0 OBJECTIVE
1.1 To lay down the procedure for the process validation of products.
2.0 SCOPE
2.1 This procedure is applicable 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.
3.0 RESPONSIBILITY
3.1 Quality Assurance to prepare and execute the validation protocol and to prepare a final report on Process Validation up to the successful completion of the three commercial batches validation and in case of any SUPAC ‘level 3 changes’ in component and composition.
3.2 Quality Assurance to prepare, and execute the validation protocol on Process Validation for post-validation batches and also to support the monitoring of validation batches for manufacturing equipment/process change.
3.3 Production to execute the manufacturing of the batches along with Quality Assurance
3.4 Head - Production to investigate and implement necessary corrective actions.
3.5 Quality Control to analyze the samples and report the results.
3.6 Quality Assurance to review the protocol for its adequacy and completeness, to sample as per validation protocol, and to review analytical results.
3.7 Validation committee, consisting of the Head of Plant or his designee, Production, Quality Control, and Quality Assurance, to review, approve the protocol and certify the final reports
4.0 ACCOUNTABILITY
4.1 Head – QA/his designee
5.0 PROCEDURE
5.1 Process validation: Process validation is establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
5.2 All the equipment / systems/facilities to be used during the process validation shall be qualified.
5.3 In general, a minimum of three (3) consecutive commercial batches shall be taken for process validation.
5.4 Process validation for a product shall include the challenge of the process parameters.
5.5 Validation batches can be released for distribution after the validation data has been reviewed and found acceptable by the validation committee.
5.6 The process validation protocol should be written and approved prior to manufacturing.
5.7 A typical validation protocol may consist of the following
5.7.1 Title of the study
5.7.2 Protocol Approvals
5.7.3 Objective Reference document
5.7.4 Product/process description
5.7.5 Process flow diagrams
5.7.6 Manufacturing equipment qualification summary
5.7.7 Process Validation Methodology
5.7.8 Sampling Test Plan (Include Analytical methods and acceptance criteria)
5.7.9 Stability studies requirements
5.7.10 Validation protocol attachments - Sampling diagram of equipment wherever applicable.
5.8 A validation report shall be prepared upon the completion of the study and may consist of the following
5.8.1 Title
5.8.2 Table of contents
5.8.3 Report certification
5.8.4 Abstract
5.8.5 Manufacturing schedule
5.8.6 Validation Procedure (details of input material, environmental conditions, manufacturing details, etc.,).
5.8.7 Reference documents, analytical results.
5.8.8 Summary
5.8.9 Annexure
5.9 A product/process will be considered validated when 3 consecutive commercial scale batches meet the acceptance criteria established in the validation protocol. In case one of the batches fails to meet the acceptance criteria the subsequent 3 consecutive batches shall be validated.
5.10 If a batch fails to meet the acceptance criteria, an investigation of the cause of failure must be conducted and corrective action will be implemented.
5.11 Validated systems / equipment / processes 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 program". The changes will be reviewed as per the "change control program" as per SOP NO……………………
5.12 Validation batches shall be subjected to stability studies.
5.13 Numbering of Process Validation Protocol / Report
5.13.1 Process Validation Protocol / Report consists of 9 alphanumerical characters, which shall be allotted by Quality Assurance Department.
5.13.2 For Example the first process validation protocol shall be numbered as PVP01-00 and the first process validation report shall be numbered as PVR01-00.
5.13.2.1 The first three alphabetical characters PVP represents Process Validation Protocol and PVR represents Process Validation Report.
5.13.2.2 The next three numerical characters are serial numbers starting from 01 and continuing serially in increments of one unit.
5.13.2.3 The seventh character is a ‘-’ as a separator.
5.13.2.4 The next two numeric characters indicate the version number of the document starting from 0 and continuing serially in increments of one unit.
6.0 ABBREVIATIONS
6.1 SUPAC - Scale-Up and Post-Approval Changes
7.0 REFERENCES
7.1 Change Control Program - SOP NO…………
8.0 ANNEXURES
8.1 Annexure: 1 - Format of Process Validation Protocol & Report Numbering Register.
END OF DOCUMENT
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