Standard Operating Procedure for Conducting Internal Audits in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish procedures for conducting internal audits of transdermal patches production processes to verify compliance with established quality standards, regulatory requirements, and company policies.

2) Scope

This SOP applies to internal audits conducted within the transdermal patches production facility, covering all departments and processes involved in manufacturing, quality control, and quality assurance.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for planning, conducting, and reporting internal audits. Production and support departments cooperate by providing necessary documentation and access during audits.

4) Procedure

4.1 Audit Planning

• 4.1.1 Schedule audits based on a predetermined audit plan, taking into account audit frequency and areas of focus identified through risk assessment.
• 4.1.2 Define audit objectives, scope, and criteria, ensuring alignment with applicable regulatory requirements, standards, and company policies.

4.2 Audit Preparation

• 4.2.1 Select qualified auditors with appropriate training and independence from the areas being audited.
• 4.2.2 Notify department heads and personnel about the upcoming audit, including the audit scope, objectives, and expected duration.

4.3 Conducting the Audit

• 4.3.1 Perform on-site audits using a checklist or audit plan to systematically review processes, procedures, documentation, and records.
• 4.3.2 Interview personnel to verify understanding and