Addressing Risk in Partner / Contractor Selection and Onboarding. Michael Davidson VP Quality Systems and Compliance March 2014

Transcription

1 Addressing Risk in Partner / Contractor Selection and Onboarding Michael Davidson VP Quality Systems and Compliance March 2014

2 Industry Trends Pfizer Overview Pfizer s Approach Risk Based Robust Due Diligence Cross functional approach Stage-Gate Process for Partner Selection and Qualification Robust Quality Oversight External Supply Risk Based Quality Oversight Model Key Performance and Leading Indicators Continuous Improvement Lessons Learned Conclusion and Examples

3 3 Outsourcing of products is on the increase Supplying regulated markets from emerging market contractors is becoming more common Complex Supply Chains becoming more routine Potential risks exist that must be mitigated Inconsistent understanding and application of global expectations and regulations across the product lifecycle Less developed quality systems Less mature Quality Culture Patient safety and product quality must be protected in this complex environment

4 Regulatory & Industry Trends Regulatory Increased Expectations: Increased pharmaceutical regulations regarding outsourced manufacturing More responsibility on companies to ensure product purity /safety made by contractors MA holder is ultimately accountable FDA investigators will be looking for more transparency between the sponsor and its contract sites regarding sponsor s application commitments and contractor s plant-wide GMP status FDA Cincinnati District Investigator Kathleen Culver at Global Outsourcing Conference at Xavier University, June 2010 Recent FDA Draft Guidance on Contract Manufacturing Arrangements for Drugs: Quality Agreements - defines the owner as being responsible for quality of product. For manufacturing violations at third parties, warnings go to both contractor and sponsor company ( Two for One ) Patient safety and product quality must be protected in this complex environment 4

5 Pfizer Global Supply Our Network Aggregation of 25+ companies 56 internal manuf. sites 130 logistics centers 300+ supply partners 22,000+ colleagues Products Key Activities Site and Logistics network Operational/Supply/ Technical support Product co-development, launch, and process optimization >175 Markets >50 Languages Significant complexity External partnerships 600+ major product groups 21,000+ SKUs 40+ technologies/ platforms

6 The Pfizer Global Supply Fundamental Value Proposition Pfizer s Control of supply chain Supply chain visibility / performance metrics Alternative supply / Failure to Supply Supply Reliability Quality / Compliance Access to facility Quality Oversight EHS Systems Cost / Value Delivery Cost stability / cost improvements Fixed asset investments avoidance Link payments to manufacturing milestones Critical to balance all three We make difficult and tough choices......however, compromise to Quality / Compliance is NOT an option

7 Quality Risk Based Approach to Due Diligence Change in Deal Structure Changes in industry & Product sourcing Changes in Regulatory Environment Licenses Co-Promotions Co-Develop Options/ Debt Structures Equity Stakes Staged M&A Mergers & Acquisitions Liability and Quality Risk Close regulatory scrutiny on contractors

8 Global Supply Business Development Support Due Diligence through Onboarding Cross functional teams engaged. Exploration Initial Project Evaluation Risk, Due Diligence Scope Evaluation Conduct Due Diligence => Endorsement Qualification Supply & Quality Agreements Risk Reduction Onboarding Transition to Operations Due Diligence Gaps Closure Quality Assess Risks Build Capabilities Supply Chain EHS Assess Risks Build Capabilities Supply Capacity, Supply Terms Contract Negotiations Global Logistics Supply Chain Other Pfizer Functions Tech Ops, Finance etc.

9 How We Deploy GMP Quality Across Pfizer Holistic, multifaceted approach to product quality Requires vigilance to ensure high quality product Rests on a strong foundation of quality culture

10 Partner Selection Model Partnership Philosophy Pillars Our partners must have robust quality and EHS systems that protect the patients, employees and the environment, regardless of deal structure Our partners must have a strong Quality Culture We cannot do it for them; THEY have to do the right thing themselves. Due Diligence Fundamental Principles Acceptable quality audit does NOT equal Quality Due Diligence Approval GMP audit WILL be component of Quality Due Diligence for all Contractors/Partners Acceptable Regulatory Inspection does NOT equal Quality Due Diligence Approval Due Diligence Quality Focus Areas Product Quality and Process Robustness Understanding risk in the Supply Chain Company Regulatory & Quality History and Quality Culture

11 Gate 1 Gate 2 Gate 3 Stage-Gate Process Quality Evaluation, Qualification, and Integration Exploration Evaluation Qualification Integration / On boarding Feasibility Minimum Acceptance Criteria Pfizer Global Supply functions Due Diligence Full Quality Audit Sterility Assurance Assessment Quality Culture Assessment Supply Chain Assessment Qualification Plan Acceptable Due Diligence CAPA plan for risk remediation / reduction Cost (resources) Governance Surveillance Testing / Person in Plant Confirmatory Quality Audit Quality Agreement Benefits Structured Stage-Gate process with defined criteria to be met at each stage Formal assessment if requirements and mitigation commitments have been met and make a final decision on partner s acceptability, prior to manufacture and commercialization Formal Qualification plans with communication and key milestones for measuring progress Clear communication and buy-in across Pfizer and key stakeholders

12 Pfizer Due Diligence Scope Critical evaluation of the manufacturing risks of a deal Identification of manufacturing / supply issues that may: Affect value of deal or deal intent Pose a significant risk to patients Pose a regulatory risk Evaluation/prioritization of potential issues/risks Company involved and Product Supply Chain Molecules; Dosage Form to be supplied

13 Partner / Site Qualification Qualification Identifies requirements and plans for qualifying new partners, including requirements for communication and progress updates at defined intervals Quality Agreement (for partners/contractors) Quality requirements achieved during the negotiation process Essential elements include Notification of regulatory activity, significant failures of Quality System or products, or change management, including time requirements Access to site and subcontractors for auditing Supply Chain Transparency

14 Partner / Site Qualification Quality Culture actively assessed throughout partnership Assessment tool developed incorporating risk level assignment Elements incorporated at each stage of Evaluation and Qualification Quality culture indicators part of the risk dashboard Continuous Improvement Focus included in Contractor Site Visit process Improvement opportunities identified and shared during site Management review meetings Partner shares active Continuous Improvement activities with Pfizer Support improved Quality Culture throughout the supply chain

15 Oversight

16 Pfizer Basic Risk Based Quality Oversight Elements Facilitate audits with Auditors Follow up with Contractor on CAPA Review Annual Product Reviews to confirm product state of control Assist exit strategy with mitigation until complete Internal issue notification Reg Agency notification Support recall process Track Contractor CAPA completion Review/endorse Contractor significant deviations Assure timely completion Track CAPA &Effectiveness Audits Product Record Reviews Contractor Exit Deviation Management Quality Due Diligence Quality System Quality Agreements Complaint Management Management Batch Notification Disposition Change Control Regulatory Inspections Perform due diligence audits to support business Negotiate/maintain Quality Agreements Review & assist with complaints Perform trending Track CAPA/effectiveness Perform risk-based Batch Record review & disposition Manage Regulatory change controls Jointly establish strategy for regulatory approval & implementation Perform Pfizer quality approval of change controls Monitor Contractor inspection activities On-site support during inspections Review & provide feedback on responses Track CAPA and CAPA effectiveness

17 17 Pfizer Contractor Risk Dashboard Pfizer has a risk-based oversight model for managing ~300 contractors Contractor Risk Dashboard key element in monitoring Quality risks Real-time data of 12 Key Quality Indicators, including Quality culture as leading indicator Weighted rating system that improves ability to understand true risks Review and escalation of any High Risk contractors / partners and review of remediation activities with senior leadership Contractor Risk Entry Contractor Name Report Period Operational Group xxxx Oct-13 Pharmaceutical Quality Agreement Quality Management Oversight Market Action/Quality Alert Notification Significant Changes Significant Deviations Quality Complaints Quality Investigation Process Communication / Quality Culture Audits and Inspections - External Audits and Inspections - Internal Exit Strategy Additional Overall Risk Justification xxxx Nov-13 Pharmaceutical xxxx Dec-13 Pharmaceutical

18 Lessons Learned At the end of each deal Pfizer performs a lessons learned exercise for: Due Diligence Qualification and Onboarding These are Cross Functional and look at all elements not just Quality Due Diligence and Onboarding processes are continually improved as a result of these sessions.

19 Conclusion

20 Assuring Success Robust Process for Partner Selection: Evaluation (Due Diligence): Selection of partners with existing acceptable / sustainable Quality Culture Understand the supply chain Qualification: Clear agreement on GMP risks with partners that may lead to Quality Risk to Patients or to any risk that may disrupt supply to patients Remediation of risks and education of partners across the supply chain Integration and On-boarding Robust Risk-Based Quality Oversight Model Active management with well defined metrics and leading risk indicators Evaluation of Quality Culture as a key indicator for success Continuous Improvement Internal through Structured Lessons Learned processes External with partner

21 The Value Quality brings to Due Diligence AAAA Pfizer identified potential partner had poor control over their Contract Manufacturers and did not move forward with deal. AAAA recalled a sterile injectable product after crystalline particulates were found in vials manufactured at company s Contract Manufacturer. YYYY YYYY identified to have inadequate oversight of supply chain. Pfizer assessment of a of sub-contractor revealed the contractor needed to enhance it s GMP controls Pfizer initiated plan to address concerns and delayed deal until remediated After deal delayed FDA issues a Warning Letter to supplier Deal was delayed 9 months until sub-contractor was fully qualified by Pfizer Product launched successfully Confidential and Internal use only. All content in this message is subject to works council and/or union consultations and other legal requirements. 21

22 22 Thank you Questions?