GxP and Quality Auditing Practices

Aims and Objectives

Audits are a fundamental part of implementing, maintaining and improving quality systems. If the audit process is deployed to the operational level of an organisation, it can serve to educate personnel and also as a means of conferring ownership for various aspects of the system.

This course is designed for operational personnel (key operators, supervisors and managers) who have a key role in quality systems implementation and will assist them to develop a system of quality audit.

Participants will develop skills in planning, conducting and reporting on internal quality audits. Techniques for preparing audit plans, performing the audit, verifying observations, reporting and corrective action will be studied and practised in a syndicate environment.

On completion, participants will be able to:

• Apply the basic principles of internal auditing
• Analyse their own quality systems in order to apply appropriate auditing activities
• Conduct internal audits to meet the requirements set out in the Codes of Good Manufacturing Practice and ISO Standards for Quality Systems
• Prepare audit check lists
• Initiate and confirm corrective actions

Contents

• Critical role of quality audit in GMP compliance & improvement.
• GMP audit schedule, managing regulatory audits in an effective manner, what to expect from GMP licensing audits.
• Documents, records & data for effective audits.
• Four fundamental steps of auditing explained in detail, tips on how to manage & facilitate audits in a constructive manner.
• Utilisation of risk management in relation to prioritising audits.

The program has a strong bias towards practice and review. On completion of this subject, students will be required to conduct a mock audit, assessing GxP risks and provide a written report on compliance status.