Introduction to the Supply Chain Risk Management Guide

1. Introduction to theSupply Chain Risk Management Guide RPSGB, London 23rd February 2010 Jill Jenkins - Pharmaceutical Quality Group

2. Today….. You will: Hear about the development of the PQG Guide, its content, structure & benefits Learn from MHRA & key industry speakers who will share their experiences on Risk Management & Supply Gain a good understanding of why Supply Chain Risk Management is so important& take away key messages We hope that you will find the PQG Guide a useful resource that you will use & share widely

3. Wave of change…. • The combination of: • Emerging low-cost suppliers • Global sourcing beyond traditional boundaries • Variation in standards & control • has meant thatSupply Chain Managementis • an increasinglyrisky business!

4. Areas highlighted…. • Supplier approval & ongoing compliance issues: • Uncommunicated changes • Inconsistent QC or yield rates • Unknown impurities • Continuity of Supply: • Single sourcing • Suppliers ceasing business • Lack of full Supply Chain transparency: • Not knowing original source of materials • Shipper integrity & on time delivery • Distribution & logistics concerns: • Security (counterfeiting/theft), cross-mixing, mislabelling, poor storage, temperature issues, delays,

5. ISO 9001:2008 ….. Reference (4.1) states: “where an organisation chooses to outsource any process that affects product conformity to requirements, the organisation shall ensure control over such processes The type and extent of control to be applied shall be defined within the Quality Management System Ensuring control over outsourced processes does not absolve the organisation of the responsibility of conformity to all customer, statutory & regulatory requirements.”

6. ICH Q10….. Defines the “accountable organisation” as being ultimately responsible for ensuring that processes are in place to assure control of outsourced activities and quality of purchased materials It requires: Assessment prior to outsourcing / selection Defined responsibilities & communication processes Monitoring & review of performance Confirmation of incoming materials against agreed supply chain

7. Regulatory expectations….. • Expect manufacturers & authorisation holders to ‘‘do the right thing’’: • Know where the Risks are • Know how big the Risks are • Be Proactive, Plan to Control and if possible, Reduce these Risks • Communicate these Risks to stakeholders & groups who can act accordingly, and • Stay in Control

8. The project team…. • Richard Smalley • David Cock • Justin Ahern • Sharon Shutler • Sharon Hooper • Jill Jenkins

9. What we set out to do…….. • Develop a freely available, downloadable Supply Chain Risk Management Guide (SCRM) based on the ICH Q9 quality risk management model • Provide a resource of information to help organisations & their suppliers adopt a common approach to Risk Management across the Supply Chain.

10. Target audience….. Pharmaceutical & Medical Device organisations Suppliers / contractors to the above industries

11. Purpose of PQG Guide….. Encourage all organisations to apply the principles of Risk Management to minimise supply chain risks & assure quality & continuity of supply Emphasise to the pharmaceutical & medical device industries & their suppliers the need to: Apply Risk Management when making sourcing decisions or changes Involve the relevant people Communicate proactively Provide information that will help supply organisations understand the regulatory requirements & expectations of the pharma & medical device industries

12. Development….. Cycle reiterated 3 times

13. The Guide at a glance…..

14. Supply Chain focus….. Consideration of controls Impact of complex systems Supplier lifecycle approach

15. Understand your business! Look internally as well as externally Internal may involve different sites / locations

16. Supply Chain tiers Know your supply chain What activities are critical to the product? Identify potential hazards & associated risks • Communication • Understanding requirements • Shared agreement

17. See the “big picture”.….. Focus too much on one source of information…… And you might just miss something important!

18. Using the PQG Guide….. • Designed for use by organisations & their suppliers • Quality Risk Management (QRM) is important to: • You • Your customers and • Your suppliers • QRM is a business process that: • Provides a common language for communication • Assists in defining the scope and rationale for decisions within the supply chain

19. Getting started? • Firstly, understand how Risk Management works • Define the overall approach • Focus on areas where it makes obvious sense & there will be a better chance of success • Decide what specific goals you want to achieve • Train /coach people in the relevant tools • Don’t try to run before you can walk

20. Structured approach….. ICH Q9 • Key messages: • Cover product life-cycle • Should be: • Pro-active • Re-iterative • Communicated • Reviewed

21. Supports continuous improvement: Proactive not reactive Ongoing cycle of risk reduction Enables more effective prioritisation & efficient use of resources Reduces risk to business & lower overall cost Improve overall customer satisfaction (regulator / purchasing company) Supply Chain Risk Management SCRM Risk Management Selection Evaluation Monitoring Improvement Foundations

22. Final thought! • Our customers include the: • Regulators • Healthcare professionals • Patient • They expect our products to meet regulatory, Safety, Quality & Efficacy requirements! • How secure is your supply chain?

23. Thank you for listening! We hope that you will find the PQG Guide to SCRM a useful resource that you will use & share widely