Rx-360Upstream Supply Chain Security A Supplier Collaborative Approach to Mitigate Risk and Enhance Transparency

Transcription

1 Rx-360Upstream Supply Chain Security A Supplier Collaborative Approach to Mitigate Risk and Enhance Transparency Presenter: Rob Welsh, VWR International, LLC VP Category Management Production Chemical Operations Co-Chair Rx-360 Supply Chain Security Steering Committee Co-Chair Rx-360 Upstream Supply Chain Committee

2 Rx360 Supply Chain Security Agenda Background on Rx360 Mission, Objectives, Operating Structure Membership, Accomplishments Supply Chain Security Steering Committee Upstream Supply Chain Committee Formation (June 2013), Charter & Focus, Participants Highlight Whitepaper content published April 2014 Resources to Know Your Supply Chain 2

3 The problem 3 3

4 Rx-360 Mission Protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain. Patient safety should never be compromised as a competitive advantage

5 Rx-360 Objectives Bringing Industry and Regulators Together to Protect Patients Worldwide Exchange public information to allow firms to adopt best practices across industry Bring industry experts together to develop responses and action when the supply chain is threatened Act as a clearinghouse for suspicious supply chain information Share individual audits and conduct joint audits Consider joint technological development for securing supply chain and detecting adulteration 5

6 Rx-360 Membership Broad and Inclusive Global Small and large companies Suppliers and manufacturers Branded and generic Regulatory agencies, standard setting bodies, and industry organizations participate as Observers 6 6

7 Current Rx-360 Membership Members Observers Manufacturers (27) AbbVie Amgen AstraZeneca Baxter Bayer Bend Research Biogen Idec Boehringer Ingelheim BMS Daiichi Sankyo Co., Ltd. Eli Lilly Forest Laboratories Roche/Genentech GSK Impax Laboratories Inc. Johnson & Johnson Merck & Co. Merz Aesthetics Mylan Inc. Novartis Pfizer Pharmaceutics International, Inc. Procter & Gamble Sanofi-Aventis Takeda Teva UCB Pharma S.A. Suppliers (30) AMPAC Fine Chemicals LLC Ash Stevens Aurisco Avantor Performance Materials, Inc. BASF Cambridge Major Laboratories, Inc. Cardinal Health Doe & Ingalls DSM Nutritional Products Ltd. FUJIFILM Diosynth Biotechnologies U.S.A., Inc. GE Healthcare Hikal Hovione Imperial Health Sciences Labochim LifeConEx Life Technologies Corp. Ligand Merck KGaA Neuland Laboratories Limited Novozymes OSO BioPharmaceuticals Manufacturing LLC Resilinc Sartorius AG Sigma Aldrich Spectrum Chemical Mfg. Corp. TempTime VWR West York Container Auditors (13) Auckerman Consulting blue inspection body GmbH BSI Supply Chain Solutions MPC Consulting LLC PharmaPact Consulting Services PSC Biotech Corp. Regulatory Compliance Associates Rephine Ltd. RMC Pharmaceutical Solutions Inc. Safis Solutions LLC SQA Services Inc. STS Consulting The Weaver Group, Inc. Associations (19) Alliance for Safe Online Pharmacies ANSI-ASQ National Accreditation Board APIC Bulk Pharmaceutical Task Force Consumer Healthcare Products Association (CHPA) Council for Responsible Nutrition European Fine Chemicals Group (EFCG) European Generic Medicines Association (EGA) EXCiPACT Health Distribution Management Association (HDMA) International Society for Pharmaceutical Engineering (ISPE) IPEC Americas IPEC Europe NSD Bio Group Parenteral Drug Association (PDA) Pharmaceutical Quality Group (PQG) Pharmaceutical Research & Manufacturers of America (PhRMA) Pharmaceutical Supply Chain Initiative (PSCI) Rx Response 7

8 Rx-360 Delivers Operational Results FTC Clearance Letter Received Issued 47 Regulatory Flash Reports Managed Fukushima Response Joint Audit Pilot Audit programs go live 6 SC Security White Papers Issued Held Upstream SC Security Conference Asia & Supplier-Led Work Groups Kickoff Initiated Medical Device & Serialization Architecture Work Groups Release of auditsplus, BSI Partnership

9 Supply Chain Security Steering Committee Co-Chairs: Rob Welsh Joe Newell ( newell@amgen.com ) Supply Chain Security Develop and share best practices and information on key supply chain security processes and enhance collaboration among supply chain stakeholders on issues of supply chain security Produce white papers Participate in webinars Create action teams as needed Accomplishments Deliverables Benchmarking Teams produce White Papers/Webinars 18 White Papers on Supply Chain Security (95 contributors from 32 companies) E.g., SCS Management System, Cargo Theft, Illegal Diversion Upstream Supply Chain Security Serialization Support Traceability Data Exchange Architecture Work Group Serialization Implementation Discussion Group Supporting Medical Device, Asia and Africa WGs with resources

10 Must Focus on End to End Supply Chain 10

11 Upstream Supply Chain WG White Paper Evolution June 2013: Committee formed July 2013: Survey Developed Aug 2013: Rx360 Membership Surveyed 34 Respondents; Pharma Respondents represented 80% of the Largest 15 Pharma Mfg.s by Revenue 50/50 Mix of Pharma Manufacturers & Suppliers Sept 2013: 6 Common themes identified December 2013: in-person meeting Majority of writing took place February Workshop at Amgen Thousand Oaks Webex sessions and phone calls to finalize through Jan.-Feb. April 22 nd date of publication and linked to website Appendix 1 Survey Appendix 2 Supply Chain Mapping Appendix 3 Risk Assessment Tool May 8 th Webinar conducted and linked to website 11

12 Upstream Supply Chain Working Group Bretta Lichtenhan, EMD Millipore Corporation Charles Calvert, Boehringer Ingelheim Ken Crossley, VWR Corporation Michael Fairbanks, Perrigo Co. Hugo Galaio, Hovione William Harclerode, Forest Laboratories Michael LeBlanc, Avantor Rob Welsh, VWR Intl. LLC Maria Macedo, Hovione Dawn Palmer, Amgen Susan Rabideau, Fugi Film Timothy P Reinhardt, Pfizer Karen Seiberlich, Amgen Carmen Wolf, Boehringer Ingelheim Joyce Yuan, Bristol Myers Squibb Greg Halvacs, Cardinal Health 12

13 Upstream Supply Chain White Paper 6 Themes/Topics 1. Supply Chain Security Awareness 2. Supply Chain Mapping 3. Intended Use 4. Risk Assessment Tools and Approaches 5. Supplier Questionnaires / Surveys 6. Change Control and Change Notification 13

14 Upstream Supply Chain White Paper Awareness Section Supply chain security = Patient Safety 2008 heparin issue 75% formal supply chain security focus 97% took measures to ensure products are not adulterated or misbranded Recognition that it requires a different mindset Awareness of Geopolitical events Know the Supply Chain Rigorous identification, selection, & monitoring 14

15 Upstream Supply Chain White Paper Awareness Section Present State Consideration to be given to: Review and verification of paperwork (certs) Tamper evident devices and packaging Photo libraries to identify packaging deviations Adulteration testing of at-risk materials 15

16 Upstream Supply Chain White Paper Awareness Section ~75% of respondents have a formal supply chain security focus on upstream process materials such as API s, excipients, and primary contact materials Program responsibilities span diverse groups Purchasing: raw materials from reputable sources Receiving: verifying material ordered Warehousing: storing materials securely Transportation: transporting materials in a controlled manner Quality Assurance: ensuring quality and pedigree of materials through audits, supplier monitoring, and testing 16

17 Upstream Supply Chain White Paper Awareness Section Know the Supply Chain Develop a Knowledge Mgmt. System Mfg. and logistical capabilities, experience, reputation, and financial condition Quality processes inclusive of CAPA plans Qualification procedures of their suppliers Robust ongoing monitoring Review systems, audits, and inspections Agreed upon KPI s 17

18 Upstream Supply Chain White Paper Supply Chain Mapping Key Benefits of Supply Chain Mapping: Enhanced transparency Development of risk profiles Manage according to risk profile Risk mitigation through continuous improvement Current challenges 1) Supply chain information is often not easily obtainable - data can be difficult to capture automatically due to origin from various sources 2) Supply chains can be very complex - involving multiple products, multiple countries, multiple logistics providers, and multiple steps. 3) Different actions which need to be taken by those who are responsible for various steps of the supply chain - as opposed to those who are ultimately accountable for the quality of the end product 18

19 Upstream Supply Chain White Paper Supply Chain Mapping Complexity increasing with globalization 55% of Survey respondents utilize supply chain mapping 2 Tool Templates: Spreadsheet Process Flow Future State Supply chain mapping processes are best applied when both consistency in the documentation and flexibility in the process to accommodate a variety of business situations Templates / tools could be used to assist in the development of supply chain maps It is expected that the level of detail obtained for various product supply chains will vary with the level of risk identified within that supply chain Tools could be modified to ensure the proper level of information is being collected 19

20 Upstream Supply Chain White Paper Intended Use Need for care in selection of materials for production and labs supporting product While various grades of materials may be technically suitable for use, the material manufacturer may not intend the material to be used in pharmaceutical production Much of the necessary quality aspects may not exist such as: Change management Quality documentation Quality agreements Supply chain transparency 20

21 Upstream Supply Chain White Paper Risk Assessment Tools and Approaches Enables informed decisions about mitigating (reducing or accepting) risk throughout the raw material supply chain Examples of tools Failure Mode Effects Analysis (FMEA) Cause & Effect Analysis (C&E matrix) Kepner-Tregoe Preliminary Risk and Hazard Analysis (PRHA/PHA) 21

22 Upstream Supply Chain White Paper Risk Mitigation Considerations Common risks to consider: Adulteration Supply Quality Political and geopolitical Fit for use Contamination Counterfeiting 22

23 Upstream Supply Chain White Paper Questionnaires / Surveys Majority of suppliers in survey receive questionnaires per month (and some receive many more!) As regulations increase and customers need to know more information, the burden on the supplier to provide this information grows Survey results demonstrated that supplier questionnaires remain a valuable tool for customer assessment of a supplier s compliance status for upstream raw material sourcing Customers and suppliers need to understand how to best deal with the practice of sending and receiving questionnaires, respectively Establishing an internal knowledge management system can serve as a resource database to facilitate the processing of customer questionnaires 23

24 Upstream Supply Chain White Paper Questionnaires / Surveys Improvement opportunities for pharmaceutical manufacturing companies and their suppliers Standardized approach Develop guidance/templates to streamline the process of obtaining relevant information and reduce the time and effort required by the suppliers Standardization could reduce the opportunity for error as well as the fatigue that suppliers experience in answering a large number of questionnaires For excipients, there exists a standardized proposed set of requirements described in the Excipient Information Package Guide Rx-360 Supplier Led working group recently(aug.2014) published a standardized questionnaire templates 24

25 Rx-360 Supplier Led Working Group Development of template supplier assessment questionnaire(s) (SAQ) (released August 2014) Webinars held to introduce SAQ. The SAQ modules are available for download on the website under the Suppliers tab. Direct link: Updated versions of the SAQ will be posted to this page as they are released. Development of template quality agreement(s) Development of standardized approach(es) to change notification processes Development of uniformly accepted definitions Any additional projects 25

26 Upstream Supply Chain White Paper Change Control and Notification ~70% confirmed that notification of change area of disconnect Important for all to understand the potential to impact final product It is the responsibility of the supplier to identify and provide notification of any changes that are outside of the validated and/or fixed system Give the customer adequate time to assess the potential impact to its product and manufacturing process when possible Some common examples of the Change Control content to be established in the Supply Agreement and/or Quality Assurance Agreement are presented below: Changes in product quality and / or source of key raw materials Changes in size and type of production equipment Changes in production site or batch size Changes regarding subcontracting of manufacturing parts and/or analytical testing Rework according e.g. ICH Q7 26

27 In Conclusion 1of 2 Supply chain security is critical to ensure the patients we serve receive the trusted, quality medicines they deserve In order to truly Know the Supply Chain, there must be a rigorous supplier identification, selection, and management process Many companies are now formalizing the process for mapping their supply chains, and are finding significant benefits Understanding material quality and the material supply chain will enable manufacturers to assess the risks and select the appropriate material for use where the ultimate responsibility lies upon the pharmaceutical manufacturer to assess and determine if the material is fit for use 27

28 In Conclusion 2 of 2 As part of their business process, companies should establish the acceptable level of risk and identify what is considered high risk Pharmaceutical manufacturing companies and their suppliers should develop a standardized approach to requests for information, as in questionnaires Such standardization could reduce the opportunity for error as well as the fatigue that suppliers experience in answering a large number of questionnaires In general, it is expected that suppliers to the pharma/biopharma sector have effective change control procedures in place (extending to their own supply base) to confirm that product characteristics and material supply will be unaffected by the intended change(s) The need for transparency in the upstream supply chain security space continues to grow 28

29 Supply Chain Vulnerabilities Cited as the #1 Risk for Life Science Companies in the June, 2014 BDO Life Sciences Risk Factor Report

30 Snapshot of Rx-360 Website: A Resource! is your one stop location for securing the supply chain 30

31 Privilege & Responsibilities Serving patients is a privilege that comes with responsibilities... Our Mission: Protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain 31

32 Appendix 32

33 Upstream Supply Chain Working Group Charter Problem Statement & Goals 33

34 Upstream Supply Chain Working Group Charter Scope Definition 34