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 compliance with procedures, and observe activities to ensure adherence to good manufacturing practices (GMP).

4.4 Audit Findings and Reporting

• 4.4.1 Document audit findings, including observations, deviations, non-conformances, and areas of improvement identified during the audit.
• 4.4.2 Classify findings based on severity and impact on product quality and compliance, and propose corrective and preventive actions (CAPA) where necessary.

4.5 Audit Closure and Follow-Up

• 4.5.1 Conduct an exit meeting with auditees to discuss audit findings, clarify any concerns, and agree on corrective actions and timelines.
• 4.5.2 Prepare and distribute an audit report to management and relevant departments, including a summary of findings, conclusions, and recommendations.

4.6 Audit Follow-Up and Verification

• 4.6.1 Monitor and track implementation of corrective actions and CAPA resulting from audit findings to ensure effectiveness and closure.
• 4.6.2 Conduct follow-up audits as scheduled to verify compliance with implemented actions and monitor continuous improvement efforts.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
GMP: Good Manufacturing Practice
CAPA: Corrective and Preventive Actions

6) Documents, if any

Audit Plan
Audit Checklist
Audit Reports
CAPA Reports

7) Reference, if any

ICH Q10: Pharmaceutical Quality System
ISO 19011: Guidelines for auditing management systems

8) SOP Version

Version 1.0