Vaisala Oyj Class A · OMXHEX:VAIAS

Vaisala Oyj Class A — Technical Presentation (April 2014)

36 slides from Vaisala Oyj Class A's technical presentation, April 2014

  1. Slide 1: Meeting USP Good Storage and Distribution Practices in a Complex Supply Chain

    Meeting USP Good Storage and Distribution Practices ina Complex Supply Chain — ‘ - : LIVE WEBCAST: Thursday, A Sa. VAISALA = Eainolosy™ 9:00 am PDT / 12:00 pm EDT. See SS See

  2. Slide 2: Webcast Notes

    Webcast Notes Interact with speaker by typing your questions in the “Q&A” box, which can be found by clicking on the red “Q&A” widget at the bottom of the screen You can enlarge the slide window at any time by clicking on the small green icon in the upper right hand corner of the slides window– th

  3. Slide 3: Today's Speakers

    Today’s Speakers Moderator: Jennifer Markarian Manufacturing Editor Pharmaceutical Technology Speakers: Paul Daniel Senior Regulatory Compliance Expert Vaisala Mary G. Foster, PharmD, Chair, USP Expert Committee, Packaging, Storage and Distribution USP Governance Committee and Council of Experts Exe

  4. Slide 4: What's New? USP <1079> Update

    What’s New? USP 36 <1079> Update Paul Daniel Senior Regulatory Compliance Expert Vaisala, Inc

  5. Slide 5: Recent History

    Recent History  Health Canada – GUI-0069 – Guidelines for Temperature Control of Drug Products during Storage and Transportation  ISPE – Good Practice Guide: Cold Chain Management Page 5 / USP Chapter 1079 Update / © Vaisala 2014

  6. Slide 6: Recent History

    Recent History  PDA – Technical Report 58 – Risk Management for Temperature Controlled Distribution  CDSCO (India) – Guidelines on Good Distribution Practice for Biological Products Page 6 / USP Chapter 1079 Update / © Vaisala 2014

  7. Slide 7: Recent History

    Recent History  CFDA (China) – Good Supply Practices for Pharmaceutical Products  EMA (Europe) – (2013/C 68/01) Good Distribution Practice of Medicinal Products for Human Use  USP 36 – Chapter <1079> Good Storage and Distribution Practices for Drug Products Page 7 / USP Chapter 1079 Update / © Va

  8. Slide 8: Goals

    Goals What’s new in USP 36 <1079>? What do the changes mean? What might be next? Page 8 / USP Chapter 1079 Update / © Vaisala 2014

  9. Slide 9: Themes

    Themes Scope and Responsibility Risk-Based Flexibility Quality Management System Temperature Tool Kit Page 9 / USP Chapter 1079 Update / © Vaisala 2014

  10. Slide 10: Scope - Focus

    Scope - Focus  Title Change:  From “Shipping” to “Distribution”  Added: “..for Drug Products  Purpose Change:  “…provide general guidance…”  “…describe good storage and distribution practices…”  Definitions:  Old: vague “Pharmacopeial preparations”  New: tightly defined “drug products” Page

  11. Slide 11: Scope - Breadth

    Scope - Breadth  Breadth  Dropped the diagram.  offer a simple statement. “… distribution processes may involve a complex movement of product around the world, differences is documentation and handling requirements, and communication among various entities…”  Message: Each case is unique. All gu

  12. Slide 12: Scope - Responsibility

    Scope - Responsibility  General Responsibility  “…All organizations along the supply chain bear responsibility.”  GDP applies to “…all organizations and individuals involved in any aspect of storage and distribution…”  Specific Responsibility :  Application Holder, Manufacturer, and Repackager

  13. Slide 13: Risk-Based Flexibility

    Risk-Based Flexibility  Old School Quality – 21 CFR 211  “Suitable and Appropriate” Solutions  New School Approach  Smart and agile. Recognition of the cost and effort here.  Examples  Label Storage Specs – Old: Standard Definitions (e.g. CRT) – New: “clearly defined” and not “subject to inter

  14. Slide 14: Flexibility Quote

    Flexibility Quote “It is recognized that conceivably there are special cases and many alternative means of fulfilling the intent of this chapter and that these means should be scientifically justified.” Page 14 / USP Chapter 1079 Update / © Vaisala 2014

  15. Slide 15: Quality Management System

    Quality Management System  Necessary support for a lean risk-based approach.  Sensitive feedback loop for continuous improvement.  This is totally new to US GDP.  Reference ICH Q9 and Q10. Page 15 / USP Chapter 1079 Update / © Vaisala 2014

  16. Slide 16: QMS for GDP

    QMS for GDP  Storage Management System  Distribution Management System  Environmental Management System  Risk Management System Page 16 / USP Chapter 1079 Update / © Vaisala 2014

  17. Slide 17: Temperature Tool Kit

    Temperature Tool Kit  Proactive Tools  Mapping – They say HOW to map!  Monitoring – – Monitor as default unless other process in place.  Qualification – Add other processes, with a deeper dive. Page 17 / USP Chapter 1079 Update / © Vaisala 2014

  18. Slide 18: Temperature Tool Kit

    Temperature Tool Kit  Reactive Tools  Deviation Management – Stability Data – Mean Kinetic Temperature (MKT) Note: You can only use these tools if you have detailed data about your products and how they have been stored. Page 18 / USP Chapter 1079 Update / © Vaisala 2014

  19. Slide 19: Future Quote

    Future Quote “It is equally important to stay current and be ready to change as new solutions evolve. These new technologies should be considered in developing strategies for good distribution practices, controls, and procedures.” Page 19 / USP Chapter 1079 Update / © Vaisala 2014

  20. Slide 20: What's next?

    What’s next?  They say stay current. I think that means stay tuned.  Technology is changing fast.  PIC/S is due to weigh in on GDP.  1000 series? Recommendations only.  Will it become enforceable?  USP Publication on counterfeit drugs? Page 20 / USP Chapter 1079 Update / © Vaisala 2014

  21. Slide 21: Summary

    Summary What’s new in USP 36 <1079>? What do the changes mean? What might be next? Page 21 / USP Chapter 1079 Update / © Vaisala 2014

  22. Slide 22: Thanks for Attending!

    Thanks for Attending! Paul Daniel Senior Regulatory Compliance Expert Vaisala, Inc. Email: paul.daniel@vaisala.com Page 22 / USP Chapter 1079 Update / © Vaisala 2014

  23. Slide 23: USP General Chapter <1083> Good Distribution Practices

    United States Pharmacopeia Packaging, Storage & Distribution Expert Committee USP PSD EC USP General Chapter <1083> Good Distribution Practices Mary G. Foster, PharmD Pharmaceutical Technology Chair, USP PSD EC Webinar April 3, 2014

  24. Slide 24: Agenda

    Agenda  United States Pharmacopeia, General Chapter, <1083> Good Distribution Practices [USP GC GDP] – Global Supply Chain Landscape, UPS Shared Data – Next Step: 2014 Expert Panel Formation  2015 - 2020 USP Cycle 24

  25. Slide 25: Global Supply Chain Landscape

    Global Supply Chain Landscape

  26. Slide 26: Global Supply Chain Landscape: Regulatory Compliance

    2 6 Global Supply Chain Landscape TOP SUPPLY CHAIN CONCERN | REGULATORY COMPLIANCE Strategies for success • 49% IT investment: bar coding, serialization, e- pedigree • 42% Increasing regulatory expertise • 41% Hiring regulatory consultants • 38% Partnering: Local distribution firms • 32% Partnering:

  27. Slide 27: Supply Chain Conclave: Regulator, Aug 2013

    Global Supply Chain Landscape Supply Chain Conclave: Regulator * Aug 2013 Exporting to US FDA supply chain process >150 Countries - 12 posts >130,000 importers - 10 countries >300,000 foreign facilities - 4 continents 27

  28. Slide 28: Global Supply Chain Landscape: Product Security

    2 8 Global Supply Chain Landscape TOP SUPPLY CHAIN CONCERN | PRODUCT SECURITY Strategies for success • 61% Investing in shipment insurance • 56% Investing in serialization or “e- pedigree” tech & other IT solutions • 47% Focused on in- transit monitoring & intervention

  29. Slide 29: Asia-Pacific Close-Up: Product Protection

    29 ASIA-PACIFIC CLOSE-UP| PRODUCT PROTECTION Product protection & solutions • 67% cite product damage & spoilage as a top concern • 76% say product security is an issue • 71% plan to invest in serialization technologies • 68% plan to invest in security-specific technologies • 61% will invest in temp

  30. Slide 30: USP Good Distribution Practices (GDP)

    USP Good Distribution Practices (GDP) • Completed new GDP revision: Introduction & 4 Sub-Chapters proposed: Pharmacopeia Forum 40 (2) Mar-Apr 2014 • 90 day comment period Good Distribution Practices Sub-Chapters 1. <1083.1> General Good Distribution Practices 2. <1083.2> Environmental Control Manage

  31. Slide 31: Future Strategies: Pharma Distribution Practices

    31 FUTURE STRATEGIES | Pharma Distribution Practices Next 3-5 years marked by Technologies Investments: 1) E-pedigree & Serialization 2) Security Specific (high value/risk)

  32. Slide 32: Closing

    Closing  Regulatory Compliance: No one regulatory authority/ organization can secure the supply chain –Prevention through strengthened regulatory capacity and tight supply chains (partnerships) –Entity-to-Entity visibility & collaboration –A collective response when substandard & counterfeit produc

  33. Slide 33: What Can You Do?

    What Can You Do?  Submit an application to serve as an USP expert volunteer  New, account-based online application  Promote the Call for Candidates to your colleagues  Apply for current cycle’s Expert Panels  Questions?  Visit the USP web site at www.usp.org  Contact USP at USPVolunteers@usp.

  34. Slide 34: Global Expertise

    Global Expertise @ Trusted Standards www.usp.org Improved Health U.S. Pharmacopeial Convention Thank You GLOBAL EXPERTISE * TRUSTED STANDARDS + IMPROVED HEALTH COPYRIGHT 2013. ALL RIGHTS RESERVED.

  35. Slide 35: Questions?

    Questions? Page 35 / USP Chapter 1079 Update / © Vaisala 2014

  36. Slide 36: Thank you!

    Thank you! Page 36 / USP Chapter 1079 Update / © Vaisala 2014

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