Supplier Oversight PQRI. September Steven Lynn, MS, CMQ/OE Vice President Global Quality Compliance Mylan

Transcription

1 Supplier Oversight September 2014 PQRI Steven Lynn, MS, CMQ/OE Vice President Global Quality Compliance Mylan

2 Agenda Mylan Background Setting the Stage with a Scenario Current State Thinking Supplier Qualification Supplier Oversight Q&A 2

3 Background 3

4 At Mylan, we are committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we: Innovate to satisfy unmet needs Make reliability and service excellence a habit Do what s right, not what s easy Impact the future through passionate global leadership 4

5 More than 20,000 dedicated individuals working around the globe to reach patients in ~140 countries and territories. Around the corner or around the globe, you ll find innovative Mylan medicines and products Scientists, researchers, technicians, marketing professionals the men and women of Mylan are committed to setting new standards in health care. 5

6 Providing access to more than 1,300 generic, brand and specialty products, with thousands more on the way. Powerful global R&D driving broad product portfolio Established regulatory track record 6 6

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8 Leveraging our global operating platform and unmatched commitment to one global quality standard to meet the needs of billions of people worldwide. Vertically integrated global manufacturing platform Reliable, proven global supply chain 8 8

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10 Setting the Stage with a Scenario 10

11 Supplier Qualification A Scenario To Ponder A True Story "Ladies and gentlemen: the story you are about to hear is true. Only the names have been changed to protect the innocent." A major supplier of multiple drug components in a big country overseas: A global health authority (HA) issued the firm an adverse inspection report in the summer of Key observations included data integrity assertions in the lab. The Firm, as a result of the adverse inspectional report voluntarily suspended API shipments from their manufacturing site to the US market, but not other non-us markets. What would you do if this was one of your suppliers? How would you respond, if you were a multi-national firm with sites in the other countries that the firm did not suspend shipments to? What went wrong? Was this just the tip of the risk iceberg or was it just a one-time occurrence? The site received multiple HA inspections in the past and was audited by a plethora of auditors from many pharma companies. How did this get missed? 11

12 Current State Thinking 12

13 Current State of the Drug Supply Chain Risks, Threats, and Vulnerabilities permeate the Drug Supply Chain Globalization Counterfeit Terrorism Diversion Counterfeit Cargo theft Intentional Adulteration Unknown threats Manufacturer Importer Wholesaler Finished dosage form or API Unknown threats Manufacturer Wholesaler Pharmacy Globalization Terrorism API and Inactive Ingredients Patient 13

14 Current ICH Guidance: Risk Management ICH Q9 Quality Risk Management Quality Risk Management Provides Guidance Regarding Outsourcing Members of the supply chain are partners Play a role in determining success Q9 recommends a comprehensive evaluation of suppliers and contract manufacturers including auditing and implementing supplier quality agreements A manufacturer's quality system will drive the management of outsourced processes and entities (connecting risk and quality management) Application of Quality Risk Management to Making Sourcing Decisions How does one quantify the true cost of ownership in a sourcing relationship? What are the worst case scenarios (essentially doing a risk evaluation)? Will there be some learning curve that dictates a need to be present at contractor? How well do the supplier s quality systems assure product quality? Systems often look good on paper Trust and confidence are built gradually 14

15 Current ICH Guidance: Quality Systems ICH Q10 - Pharmaceutical Quality Systems Guidance Regarding Outsourcing Control and review of all outsourcing activities is an element of a manufacturer s pharmaceutical quality system. Manufacturer is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials. A manufacturer should have adequate procedures for auditing and qualifying facilities prior to outsourcing and throughout the process and for contract management and supervision. 15

16 Supplier Qualification 16

17 Supplier Qualification cont. Supplier vs. Contractor Definitions Supplier Refers to a company outside of the your internal network that provides components for use in the manufacture of finished drug products, APIs or medical devices. Such items may include, but are not limited to, active pharmaceutical ingredients, container-closure systems, labeling or other printed material for use in the manufacture or packaging of finished product. Contractor refers to a company outside of your network that performs a service such as calibration, or filter installation and certification, or cleaning services at a Mylan site. For the purpose of this discussion we are focusing on Suppliers. 17

18 Supplier Qualification What is the Magnitude of the Risk? 18

19 Supplier Qualification cont. Supplier Selection, Qualification, and Monitoring The choice of a supplier is a critical one Supplier commitment to quality can vary how does a firm ensure they re receiving high-quality supplies? Their production lifecycle monitoring programs are sometimes deficient - What can be done on your firm s behalf? Robust Evaluation - How does a firm ensure there s robust ongoing evaluation of reliability (state of qualification to ensure state of control)? Disqualification - When should you disqualify a supplier? Under what circumstances? Uncorrected non-compliance? 19

20 Supplier Qualification cont. Qualification of Suppliers Qualification is part of an overall lifecycle approach to supplier management. Unlikely that any one approach can possibly cover all qualification scenarios Utilize a risk evaluation framework Lifecycle approach includes: Prospective supplier selection Qualification activities Supplier approval Maintenance of qualified status of supplier 20

21 Supplier Qualification cont. A Typical Process in the Pharma Industry Identify the Need (New or Change) Identify the potential suppliers Apply Risk Criteria (QRM) Utilize Prior Knowledge of the Supplier (Friends and Family Plan) Qualify the Supplier Contract Process Oversight of Supplier Throughout the Lifecycle Suppler Questionnaire Tech Agreement/ Quality Agreement No Positive Response? Yes Go Fish Onsite Audit No Positive Outcome? 21

22 Supplier Qualification cont. What s a Firm to Do? Defined due diligence process Questionnaire/Survey In-depth risk evaluation GxP Audit(s) Change control review (how do they handle change?) Technical Agreements / Quality Agreements Supplier license documentation Approval of supplier 22

23 Supplier Qualification cont. Some Thoughts on Technical Agreements / Quality Agreements: Ensure you have: The identification of the supplier and the exact address used for the manufacturing operation. Provisions to allow periodic audits of CGMP and contract specifics; A description of the product(s) and its intended use Commitment to share information from inspections and other regulatory communications Procedures for handling changes e.g., new equipment, facility modifications, change in key personnel, change in SOPs or test methods Measurement Systems: Supplier Scorecards (as it pertains to ongoing supplier management) Defined monitoring of risk-based parameters such as: Rejection Rates; Right First Time, Inspection/Audit Findings; and Investigations Contract manufacturer should fully inform the product owner of all deviations, changes, OOS results, investigations, as well adverse events for the affected product. errors, as 23

24 Supplier Oversight 24

25 Supplier Oversight Establishing a robust ongoing - oversight program that includes: Comprehensive supplier audits, including site visits (questionnaires and site visits); Detailed Quality Agreements; Appropriate ongoing QC of incoming lots; and Forecasting Approaches (e.g., market trends such as shortages etc.). Only doing business with trustworthy sources Avoiding grey and black markets Qualify the supply chain with standards Good manufacturing practices Good distribution practices Integrity and sustainability Implementing a comprehensive approach to monitor ingredient supply chain integrity. 25

26 Supplier Oversight cont. Routine Testing of Incoming Supplies and In-Process Testing Ongoing Oversight Incoming Supply Verification and Testing In-Process Controls and Testing QC Release Testing Audit s Per Risk-based Schedule Survey/ Questionaire What Else Can be Done? Batch Release External Intelligence (i.e. Rx360, USP) Release/ Reject Decision? 26

27 Supplier Qualification Internal Supplier Management Program Some Additional Thoughts Understanding the universe of suppliers; Establishing minimums in audit cycle and technical agreements; Establishing priorities based on business requirements; Evaluating new and existing suppliers; Maintaining and strengthening relationships; and Benefits Understanding risk Use as a basis for reduced testing 27

28 Thank You Click to edit Steven Lynn, MS, CMQ/OE Vice President Global Quality Compliance Mylan 28

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