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.