Extractables and Leachables Control Strategies

Summary

Regulatory expectations for the control of extractables and leachables (E&L) have evolved greatly in recent years. This three-day course sets out the regulatory and scientific considerations concerning E&L in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/leachable study necessary?”, and “How do I choose appropriate extraction conditions?”. Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. The course draws on information contained in current regulatory guidance (such as ICH Q3E) as well as influential publications from bodies such as the Product Quality Research Institute (PQRI), BioPhorum and the Extractables & Leachables Safety Information Exchange (ELSIE).

Learning Objectives

By attending this course, you will:

• Understand how extractables and leachables fit into the wider context of pharmaceutical impurities
• Be able to identify the common types of leachable contaminants associated with different packaging materials
• Know how to perform an extractables/leachables risk assessment
• Be aware of current EU, US and WHO guidance on extractables and leachables
• Appreciate the risks from glass and plastic materials
• Understand the analytical approaches to extractables and leachables analysis
• Be aware of common analytical errors that can affect data reliability
• Become familiar with the Extractables and Leachables Safety Information Exchange (ELSIE) and its approach to controlling leachables risk.

Key Topics

• General approaches for the control of pharmaceutical impurities
• Options for setting control limits (the Safety Concern Threshold)
• Applying the principles of quality risk management to E&L
• Common leachables from glass and plastic materials and their impact on product quality
• Designing an appropriate extractables study
• Analytical approaches for the detection, identification, and quantitation of E&L
• Specifying the Analytical Evaluation Threshold (AET)
• Common analytical errors in E&L studies
• The ELSIE approach to risk-based E&L control

Who should attend?

The course is intended for:

Personnel of pharmaceutical companies and their suppliers who:

• are responsible for qualification of extractables/leachables
• perform leachables/extractables testing
• work in quality control of packaging materials
• select packaging and product contact materials

As well as:

• Regulatory affairs professionals
• Product development managers
• Analytical chemists
• Quality assurance personnel
• Toxicologists

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Revisit recorded sessions for 7 days
• Training in digital format
• Digital and LinkedIn certificates