Good Manufacturing Practices (GMP) RCC Stakeholder Webinar May 8, 2014

1. Good Manufacturing Practices (GMP)RCC Stakeholder WebinarMay 8, 2014 Health Canada/Health Products and Food Branch Robin Chiponski, robin.chiponski@hc-sc.gc.ca Health and Human Services/Food and Drug Administration Carmelo Rosa, carmelo.rosa@fda.hhs.gov.

2. Content • Overview of the Initiative • Update and Accomplishments • Path Forward • Questions

3. Overview of the initiative • Good Manufacturing Practices (GMP) Work Plan • Proposal • Identify mechanisms for possible regulatory alignment and mutual reliance in such areas as  product review and inspection of manufacturing facilities, as well as establishing  requirements/standards where appropriate • Deliverable Outcome • Enhance collaboration on compliance and enforcement by increasing mutual reliance on each other’s routine surveillance good manufacturing practices (GMP) inspection reports of manufacturing facilities for drugs and personal products, rather than having to conduct unnecessarily duplicative inspections in the other country.

4. Overview of the initiative • GMP Work Plan • A multi-phase approach was used to attain the objective of the RCC Initiative: • Planning Phase (0 to 6 months) • Confidence Building Phase (6-18 months) • Layout intermediate goals in 6 month increments through development of the scope and framework for the project; • Determine reliable processes for exchange of confidential information, and defining a common list of sites of interest in both the U.S. and Canada. • Mutual Reliance (Beyond 18 months)

5. Update and Accomplishments • Information Exchange • Platform for both agencies to exchange inspection and compliance information regarding sites of common interest. • Greater understanding of each agency’s respective regulatory system and operational framework.

6. Update and Accomplishments • Observational Inspections • Criteria for the GMP observational inspections and assessment tools (guidelines and reporting template) were developed and approved by both agencies. • Assessment criteria developed were divided into four categories: Preparation for inspection, Conduct of inspection, Inspection report and Post-inspection actions.

7. Update and Accomplishments • Observational Inspections contd. • Phase 1 - Exchange of GMP inspection reports and information sharing via GMP Working Group (WG). • Phase 2 - Confidence building exercise to understand each agency’s respective regulatory system and operational framework. • Four observational inspections were conducted: • Two in Canada and two in the U.S. • Each agency led one inspection in each country, while the other agency observed.

8. Update and Accomplishments • Accomplishments • Opportunity for exchange of major regulatory actions • Opportunity for exchange of inspection schedules • Monthly teleconference meetings between both agencies: • Improved understanding / interpretation of inspection processes, results and tools

9. Conclusions • Conclusions • Both organizations acknowledge similarities in inspectional approach and GMP principles applied by each agency. • In an equal manner, it was recognized that differences exist between FDA and HC in inspectional practices. • RCC GMP Initiative provided a great opportunity to learn about each agency’s processes and regulatory structure.

10. Path Forward • Path Forward • Continued communication and collaboration including information sharing between FDA and HC • Future work will occur in a variety of platforms, including PIC/S as both FDA and HC are current active members, as well as potentially multi-lateral pilot programs to ensure the continued safety, quality and efficacy of pharmaceutical drug products crossing our borders. 

11. Questions Thank You Questions?