operators.
Validation Team: Composed of technical personnel responsible for designing the validation protocol, executing the validation runs, and analyzing the results.
Maintenance Personnel: Ensures that equipment used in the manufacturing process is properly calibrated and functioning.

4) Procedure

The following steps should be followed for the process validation of ophthalmic preparation manufacturing:

1. Preparation for Validation:
1.1 Review the batch records to identify critical process parameters (CPPs) for each step of the ophthalmic preparation manufacturing process.
1.2 Develop the process validation protocol, which should include objectives, scope, process flow, equipment, and personnel involved.
1.3 Ensure that all equipment, such as mixing vessels, sterilizers, filling machines, and packaging lines, is properly calibrated and operational before initiating the validation process.

2. Validation Protocol:
2.1 Protocol Design: The protocol should be designed based on the formulation of the ophthalmic preparation and the corresponding manufacturing process.
2.2 Defining Acceptance Criteria: Establish acceptance criteria for critical parameters such as sterility, pH, viscosity, filling accuracy, and container closure integrity.
2.3 Risk Assessment: Conduct a risk assessment to identify critical quality attributes (CQAs) and corresponding critical process parameters (CPPs). This ensures potential risks are identified and mitigated effectively.

3. Execution of Validation:
3.1 Raw Material Validation: Ensure that raw materials, such as excipients, preservatives, and active pharmaceutical ingredients (APIs), meet quality specifications before use.
3.2 Mixing and Compounding: Validate the mixing and compounding process by ensuring uniformity of the ingredients and proper incorporation of APIs into the formulation.
3.3 Sterilization: Validate the sterilization process for ophthalmic preparations to ensure that the product is free from microbial contamination. This can include methods like autoclaving, filtration, or aseptic processing.
3.4 Filling: Validate the filling process for ophthalmic preparations to ensure proper fill volume and absence of contamination.
3.5 Packaging: Validate the packaging process to ensure that the containers are appropriately sealed, labeled, and that they meet regulatory and quality standards. Ensure that the packaging prevents contamination during storage and handling.

4. Documentation and Reporting:
4.1 Record all data during the validation process, including batch records, equipment logs, process parameters, and test results.
4.2 Ensure that all forms, reports, and certificates are completed and signed by the responsible personnel.
4.3 Perform statistical analysis of the data to assess the process capability and confirm that the process consistently meets the acceptance criteria.
4.4 Prepare a final validation report summarizing the results, including any deviations from the acceptance criteria and corrective actions taken, if necessary.

5. Revalidation:
5.1 Revalidate the process if there are significant changes to the formulation, equipment, or critical process parameters.
5.2 Conduct periodic revalidation to ensure continued compliance with regulatory requirements and to confirm consistent product quality.

5) Abbreviations

• QA: Quality Assurance
• CPP: Critical Process Parameter
• CQA: Critical Quality Attribute
• SOP: Standard Operating Procedure

6) Documents

• Process Validation Protocol
• Batch Production Records
• Equipment Calibration Logs
• Process Validation Reports
• Raw Material Certificates of Analysis
• Statistical Analysis Data

7) Reference

• International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Process Validation
• ISO 9001: Quality Management Systems – Requirements

8) SOP Version

Version 1.0 – Effective Date: DD/MM/YYYY

Annexure

Template 1: Raw Material Certificate of Analysis

Material ID	Supplier	Batch No.	Test Result	Approved By
Material Number	Supplier Name	Batch Number	Test Result	QC Name

Template 2: Mixing and Compounding Record

Batch No.	Mixing Date	Mixing Duration	Operator Initials	Remarks
Batch Number	DD/MM/YYYY	Duration in minutes	Operator Name	Process completed as per SOP

Template 3: Sterilization Process Record

Date	Time	Operator Initials	Sterilization Duration	Temperature	Remarks
DD/MM/YYYY	HH:MM	Operator Name	Duration in minutes	Temperature in °C	Process completed as per SOP

Template 4: Filling Process Record

Batch No.	Filling Date	Volume Filled	Operator Initials	Supervisor Signature
Batch Number	DD/MM/YYYY	Volume in mL	Operator Name	Supervisor Name

Template 5: Container Closure Integrity Test

Container Type	Test Date	Test Method	Result	Approved By
Vial/Ampoule/Syringe	DD/MM/YYYY	Test Method Used	Pass/Fail	QA Name

Template 6: Statistical Analysis Data

Sample ID	Test Type	Mean	Standard Deviation	Result
Sample Number	Test Name	Mean Value	Standard Deviation	Pass/Fail