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
- Identify non-conformances in the control of stability studies
- Appreciate the regulatory requirements for reference and retention samples
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
- Control of stability studies
- Requirements for reference and retention samples
Who will Benefit
- GMP auditors
- Quality assurance professionals
- Laboratory managers
- Quality management
