Exploring Extractables & Leachables studies for Orally Inhaled and Nasal Drug Products (OINDP) to ensure delivery system compliance
Dive into the world of extractable and leachable testing tailored for inhalation devices and orally inhaled nasal drug products (OINDP). In this webinar, hosted by Nick Morley, we help you overcome the challenges behind ensuring the safety and efficacy of these products.
Why should I watch this OINDP webinar?
In this webinar, we'll delve into the materials compliance challenges surrounding OINDPs, shedding light on the critical aspects that affect patient safety, and presenting you with the information required to safeguard patient health and maintain compliance with stringent regulatory standards. The webinar covers the following:
- Ensuring patient safety: Learn how extractables and leachables testing ensures patient safety by identifying compounds that may migrate from materials used within OINDP and potentially harm end-users.
- Navigating regulatory bodies: Understand the stringent regulatory requirements and guidelines set by bodies like the FDA and EMA to ensure OINDP safety and compliance.
- Impacts of material choice: Explore real-life cases of OINDPs that reveal the impact of materials on product quality and patient outcomes, such as instances where leachables affected patient health.
- Complexities in Testing: Gain insights into the unique challenges faced during testing, including the diverse range of chemical species and the evolving regulatory landscape pertinent to OINDP.
Standards Discussed
- USP Standards: Explore USP <1663> and <1664>, providing guidance on assessment methods for extractables and leachables in pharmaceutical packaging systems.
- ISO Guidelines: Understand the significance of ISO 10993 and ISO 18562, key standards governing biocompatibility and breathing gas pathway assessment for medical devices.
- FDA Guidance: Delve into FDA guidelines for container closure systems, examining the critical regulatory aspects that shape extractable and leachable testing protocols.
Critical to OINDP safety
This webinar is of interest to Professionals involved in pharmaceuticals, medical devices, regulatory affairs, and quality control seeking a deeper understanding of extractable and leachable testing's impact on product safety and compliance.
Key topics covered in our webinar
- Definitions and Differences: Understand the distinction between extractables and leachables and why their assessment is crucial for ensuring OINDP safety.
- Risk Assessment: Explore the risk matrix highlighting the degrees of concern based on the root of administration and packaging component interaction likelihood.
- Regulatory Insights: Gain valuable insights into how regulatory interests drive the need for meticulous extractable and leachable testing.
- Challenges and Solutions in OINDP testing: Uncover the complexities of testing methodologies, reporting thresholds, and detection limits, and explore potential solutions.
Watch our OINDP Webinar
Don't miss this opportunity to explore the pivotal role of extractable and leachable testing in ensuring the safety and efficacy of inhaler and nasal drug products. Download now and gain invaluable insights from industry expert Nick Morley.
For inquiries or further information, contact us directly. We're here to address your concerns and guide you through this critical aspect of product development.
Exploring Extractables & Leachables studies for Orally Inhaled and Nasal Drug Products (OINDP) to ensure packaging and delivery system compliance - excerpt.
"Extractables are compounds that can be extracted from a device container closure system or processing equipment under exaggerated conditions... Leachables, on the other hand, are compounds that migrate during the manufacturer storage or clinical use conditions... Extractable data gives us an idea of the potential impact, whereas leachable data gives us an idea of the actual impact of the materials that are used."