Standard Operating Procedure for Audit Management System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a comprehensive Audit Management System (AMS) to ensure regular and systematic audits are conducted to verify compliance with regulatory requirements, company policies, and to identify areas for continuous improvement in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to all departments and processes involved in the production of ocular dosage forms, including eye drops, ointments, gels, and inserts. It covers internal audits, external audits, and follow-up actions.

3) Responsibilities

The Quality Assurance (QA) department is responsible for planning, coordinating, and executing the audit program. Department heads and employees must cooperate and provide necessary information during audits. The management team is responsible for reviewing audit findings and ensuring corrective actions are implemented.

4) Procedure

4.1 Audit Planning

1. Develop an annual audit schedule covering all critical processes and areas.
2. Determine the frequency of audits based on risk assessment and regulatory requirements.
3. Assign qualified auditors for each audit, ensuring objectivity and impartiality.

4.2 Audit Preparation

1. Define the scope, objectives, and criteria for each audit.
2. Prepare an audit checklist based on relevant SOPs, regulatory guidelines, and company policies.
3. Notify the auditees in advance, providing them with the audit plan and checklist.

4.3 Conducting Audits

1. Conduct opening meetings with auditees to explain the audit process and objectives.
2. Perform the audit by reviewing documents, records, and observing operations.
3. Interview relevant personnel to gather information and clarify findings.
4. Document all observations, non-conformances, and opportunities for improvement.

4.4 Reporting Audit Findings

1. Prepare an audit report summarizing the findings, including non-conformances and recommendations.
2. Conduct a closing meeting with auditees to present the audit findings and discuss corrective actions.
3. Distribute the audit report to relevant stakeholders, including the management team.

4.5 Corrective and Preventive Actions (CAPA)

1. Develop a CAPA plan to address identified non-conformances and prevent recurrence.
2. Assign responsible personnel and set deadlines for implementing corrective actions.
3. Monitor the progress of CAPA implementation and verify effectiveness.

4.6 Follow-Up Audits

1. Schedule follow-up audits to verify the implementation and effectiveness of corrective actions.
2. Document follow-up audit findings and update the audit report accordingly.

4.7 Continuous Improvement

1. Review audit findings and trends regularly to identify areas for systemic improvement.
2. Incorporate lessons learned from audits into training programs and SOP updates.
3. Adjust the audit plan and criteria based on feedback and evolving regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
AMS: Audit Management System
QA: Quality Assurance
CAPA: Corrective and Preventive Actions

6) Documents, if any

1. Annual audit schedule
2. Audit plans
3. Audit checklists
4. Audit reports
5. CAPA plans
6. Follow-up audit reports

7) Reference, if any

ISO 19011: Guidelines for auditing management systems
Good Manufacturing Practices (GMP) guidelines
Internal company policies and SOPs

8) SOP Version

Version 1.0