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

1) Purpose

The purpose of this SOP is to establish a comprehensive Quality Assurance System (QAS) to ensure that all processes related to the manufacturing of ocular dosage forms, including eye drops, ointments, gels, and inserts, comply with regulatory requirements and meet predefined quality standards. This SOP aims to safeguard product quality, safety, efficacy, and patient welfare.

2) Scope

This SOP applies to all personnel involved in the manufacturing, testing, and release of ocular dosage forms. It encompasses all aspects of quality assurance activities, including document control, training, audits, inspections, deviations, change control, and continuous improvement initiatives.

3) Responsibilities

The Quality Assurance (QA) department is responsible for implementing and maintaining the QAS. QA personnel ensure adherence to SOPs, regulatory requirements, and industry best practices. All department heads and personnel are accountable for following established procedures and contributing to quality objectives.

4) Procedure

4.1 Document Control

1. Establish and maintain a Document Control System to manage SOPs, batch records, specifications, forms, and other quality-related documents.
2. Ensure all documents are current, approved, and accessible to authorized personnel.
3. Implement a version control system and archive obsolete documents as per retention policies.

4.2 Training

1. Develop a Training Program to ensure all personnel are trained on relevant SOPs, GMP principles, and job-specific responsibilities.
2. Maintain training records to document training completion, competency assessments, and refresher training sessions.

4.3 Audits and Inspections

1. Plan and conduct internal audits to verify compliance with SOPs, GMP guidelines, and regulatory requirements.
2. Perform supplier audits and inspections to assess compliance with quality agreements and specifications.
3. Document audit findings, corrective actions, and follow-up activities.

4.4 Deviations and Non-conformances

1. Establish a Deviation Management System to investigate and resolve deviations from established procedures.
2. Initiate corrective actions to address root causes and prevent recurrence of deviations.
3. Document deviation investigations, impact assessments, and corrective actions taken.

4.5 Change Control

1. Implement a Change Control System to evaluate and approve changes that may impact product quality, safety, or efficacy.
2. Review change requests, assess risks, and verify implementation of approved changes.
3. Document change control decisions and maintain change history records.

4.6 Continuous Improvement

1. Promote a culture of continuous improvement through quality risk management, CAPA investigations, and process optimization initiatives.
2. Monitor quality metrics and implement improvements based on data-driven insights.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QAS: Quality Assurance System
QA: Quality Assurance
GMP: Good Manufacturing Practices
CAPA: Corrective and Preventive Action

6) Documents, if any

1. Quality Manual
2. SOPs and Work Instructions
3. Training Records
4. Audit Reports
5. Deviation and Non-conformance Reports
6. Change Control Records

7) Reference, if any

Good Manufacturing Practices (GMP) guidelines
International Conference on Harmonization (ICH) guidelines Q7 and Q10
Company-specific quality policies and procedures

8) SOP Version

Version 1.0