Laboratory Inspection and Auditing

Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.

By the end of the course, attendees will be able to:

• Identify non-conformance to cGMP regulations in analytical operations
• Understand the key steps in the analytical process
• Recognize commonly-used analytical techniques and instruments
• Appreciate the significance of pharmacopoeias in analytical operations
• Understand the requirements for controlling reference standards, reagents and important consumables
• Appreciate the importance of GMP controls over analytical method suitability (validation, verification and transfer)
• Classify analytical instruments according to quality risk and understand the qualification requirements for each class
• Understand current expectations for data integrity controls, including electronic data systems

Learning Objectives:

• US and EU GMPs relating to quality control operations
• Appropriate GMP controls at each step in the analytical process
• Information provided by different analytical techniques
• Pharmacopoeias – contents, structure and regulatory significance
• Significance of ICH guidance
• Quality requirements for reference standards and reagents
• What are critical consumables and how should they be controlled?
• Control of analytical methods over their lifecycle
• Appropriate qualification of analytical instruments
• Data integrity – current expectations