Standard Operating Procedure for Quality Control System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to define procedures for the quality control system in the manufacturing of ocular dosage forms to ensure that products meet specified quality standards.

2) Scope

This SOP applies to all quality control activities and measures implemented within the facility to verify the quality of ocular dosage forms during manufacturing.

3) Responsibilities

Quality control personnel are responsible for implementing and maintaining compliance with this SOP. Production personnel are responsible for providing necessary samples and supporting quality control activities.

4) Procedure

4.1 Sampling and Testing

1. Collect representative samples of raw materials, in-process materials, and finished products according to approved sampling plans.
2. Conduct physical, chemical, and microbiological tests on samples using validated methods and equipment.
3. Document and report test results accurately and promptly.

4.2 Analytical Method Validation

1. Validate analytical methods used for testing raw materials, in-process materials, and finished products.
2. Ensure that validation protocols and acceptance criteria are established and followed.
3. Review and approve method validation reports before implementation.

4.3 Quality Assurance Checks

1. Perform visual inspections and checks to ensure compliance with specifications and standards.
2. Verify adherence to good documentation practices (GDP) during quality control activities.
3. Implement controls to prevent cross-contamination and mix-ups during testing.

4.4 Quality Control Documentation

1. Maintain accurate and complete records of all quality control activities, including test results, deviations, and corrective actions.
2. Ensure documentation is reviewed and approved in accordance with established procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Batch records and testing records
2. Analytical method validation reports
3. Quality control logbooks

7) Reference, if any

ICH guidelines for pharmaceutical quality control

8) SOP Version

Version 1.0