To lay down a procedure for minimum requirement for validation or revalidation of manufacturing process applicable to marketed drug products in order to provide documented evidence that each specific process will consistently yield a product meeting all quality and design specifications.
Process validation may be prospective, retrospective or concurrent and is based on assumption that equipment have been completed prior to commencing process validation for any product.
3.1 Officers-Quality Assurance
3.1.1 To prepare validation protocol.
3.1.2 To ensure the activities to be followed as per the approved protocol.
3.1.3 To withdraw the sample as per sampling program.
3.2 Executive-Quality Assurance
3.2.1 To evaluate the analytical report.
3.2.2 To prepare the validation report.
3.3 Officers-Quality Control
3.3.1 To analyze the samples.
3.4 Executive-Quality Control
3.4.1 To review the protocol.
3.4.2 To check the result of the analysis.
3.5 Manager-Quality Assurance
3.5.1 To approve the protocol.
3.5.2 To-co-coordinate the activity.
3.5.3 To review and approve the validation report.
3.5.4 To organize the training and impart the training before validation.
3.6.1 To review validation protocol & report and organize the activity.
3.7.1 To review the protocol and provide the required services.
Head-Quality Assurance : For Compliance.
5.1 Draw up a detailed flow chart of the process to be validated with each major and minor stage being differentiated (incorporate sub-stages, if required in the event of any major stage)
5.2 Prepare detailed flow sheet for each stage corresponding to individual in the process.
5.3 Define the critical factors/operations, which assure the reliability of the process.
5.4 Prepare a written validation protocol for each critical operation/stages for any related minor operation/stage.
5.5 A validation protocol including the following:
5.5.1 Pre Approval Page
5.5.4 Batches to be validated
5.5.5 Process Validation Team & Responsibility
5.5.6 Reference Documents & Documents Verification
5.5.7 Description of Utilities and Equipment Involved in Manufacturing Process
5.5.8 Vendor List
5.5.9 Master Formula
5.5.10 Manufacturing Process Flow Chart
5.5.11 Process Control/Monitoring Parameters
5.5.12 Sampling Plan
5.5.13 Manufacturing Process
5.5.16 Change Control
5.5.18 Criteria for Revalidation
5.5.19 List of SOPs
5.5.21 Post Approval Page
5.6 Run the test as per the written protocols and under conditions conforming to the actual production condition.
5.7 Verify the performance of the critical factors by evaluation of data for conformance to specifications.
5.8 Interpret the results and in case the process performs as per the predetermined specification. Consider the process validated.
5.9 for non-confirming validation data, critically scrutinize the data collected, recommend the corrective actions and revalidate the process.
5.10 File the completed validated document of the process along with the test results of analysis and interpretation confirming its satisfactory performance in a master file for validation of the process along with such other data like stability studies for the process or product.
5.11 Get the approval of the quality head each validation performed.
- Numbering of the Process validation protocol & Report
C/PVP/YY/MM/XXX (For Protocol)
C/PVR/YY/MM/XXX (For Report)
C– Company Name
PVP – Process validation Protocol
PVR -Process validation Report
YY – last 2 digit of current Year (19 for 2019, 20 for 2020)
MM -Month (01 for Jan., 02 for February, 03 for March………………….12 for Dec.)
XXX – Serial Number of the Process Validation Protocol & Report in respective month.
Trainer : Head Quality Assurance
Trainees: Staff of all the departments
Master Copy : Quality Assurance
Controlled Copy : All Department
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- 11.REVISION HISTORY OF CHANGE
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