Standard Operating Procedure for Conducting Internal Audits in Gels Production

1) Purpose

The purpose of this SOP is to outline the procedures for planning, conducting, and reporting internal audits of the gels production processes to ensure compliance with regulatory requirements and continuous improvement.

2) Scope

This SOP applies to all personnel involved in conducting internal audits within the pharmaceutical manufacturing facility’s gels production department.

3) Responsibilities

Quality Assurance (QA) Team: Plan and execute internal audits, review audit findings, and ensure corrective actions are implemented.
Production Department: Provide access to production areas and records during audits, and participate in audit interviews as required.
Management: Review audit reports, approve corrective actions, and ensure audit recommendations are implemented.

4) Procedure

4.1 Audit Planning
4.1.1 Identify audit objectives, scope, and criteria based on regulatory requirements and company policies.
4.1.2 Develop an audit schedule and notify relevant departments of audit dates.

4.2 Audit Execution
4.2.1 Conduct opening meetings to communicate audit objectives, scope, and procedures to auditees.
4.2.2 Review documentation, procedures, and records related to gels production processes.

4.3 Audit Techniques
4.3.1 Use systematic audit techniques such as interviews, observations, and document reviews to gather audit evidence.
4.3.2 Verify compliance with SOPs, GMP guidelines, and regulatory requirements.

4.4 Audit Reporting
4.4.1 Document audit findings, including observations, non-conformities, and areas of improvement.
4.4.2 Classify audit findings based on severity and potential impact on product quality and compliance.

4.5 Corrective Actions
4.5.1 Issue audit reports to relevant departments and management for review and response.
4.5.2 Track and monitor implementation of corrective actions to address identified non-conformities.

4.6 Follow-Up Audits
4.6.1 Conduct follow-up audits to verify the effectiveness of corrective actions taken in response to previous audits.
4.6.2 Close out audit findings and update records accordingly upon satisfactory completion of corrective actions.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
GMP: Good Manufacturing Practice

6) Documents, if any

– Audit Plan and Schedule
– Audit Checklists
– Audit Reports and Findings

7) Reference, if any

– FDA CFR 21 Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q10: Pharmaceutical Quality System
– Company-specific audit procedures and guidelines

8) SOP Version

Version 1.0