Principal Packaging Engineer
1:50 PM Preparing your Supply for the Regulatory Provisions Outlined in Health Canada Guide-00069 from Frozen to CRT
Tony and Rafik will discuss the Health Canada Guide-00069 regulations and requirements in Canada and provide detailed examples compliance and non-compliance regarding:
- Review guidelines for products in transit: stability data requirements and temperature mapping
- Discus the regulatory scope of temperature monitoring for CRT
- Risk valuation and mitigation and analyze examples of compliance and non-compliance
- How to implement locally to distribute to Canadian customers to fulfill authority requirements
- Discuss the global regulatory landscape for CRT products and where they may get flagged more often
2:35 PM Application of Life-Cycle Concepts from the ICH and FDA to Supply Cold Chain with a Focus on Continued Verification
With the FDA’s adoption of policies favoring continuous improvement and use of new technologies, biopharma cold chain sector will also experience fast paces changes for the better. Ajay is working on implementing new innovations within validation requirements and their 45 Million USD budget to improve profitability.
- Discuss ICHQ12 guidance in order to utilize flexibility across the supply chain
- Improve the quality of design method by adding trials and studies
- Assess distribution, R&D investments, and various studies on distribution and temperature
An independent group of drug manufacturers and suppliers has formed with the goal of developing and publishing technical guidance that addresses the relevant needs of the industry. The first workgroup focused on the reuse of passive thermal packaging systems. This peer developed and reviewed guidance defines a representative standard and hopes to drive standardization for the advancement of the industry. This panel discussion will cover:
- Details about the formation of the group
- An overview of the technical paper content including passive thermal packaging system types, reuse qualification, refurbishment service and inspection details
- Future of the group including new topics and membership
Transport, handling and storage of temperature sensitive pharma-products throughout the entire supply chain have during the last 5 years reached an un-necessary high level of complexity. Beside the huge amount of regulatory demands, manufacturers of cold chain bio-pharma products struggle themselves to find the best and most efficient solution to meet an ever growing market, volume and new product port-folio. Hence, this presentation will share the specifics of a best practice approach for the industry - on a best-in-class approach to transport qualification and validation. The latter developed by collaboration between biopharma manufactures, freight forwards and shipper vendors.
The need for a common approach to Transport Qualification and Validation will be discussed through the following discussion points:
- Fix multiple approaches on how to perform transport qualification and validation to one minimum required approach across manufacturers
- Align inconsistent industry interpretations of the regulatory requirements to ‘one voice and one approach’ to understand, implement and meet future requirements
- Meet pharma requirements to aligning specific comprehensive OQ chamber studies, ambient temperature simulation, specific industry demands such as payload, durations, #runs, seasons, materials to test, probe mapping and locations, etc.
- Increase amount of various shipping solutions to secure ONE standard