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Rx-360
An International Pharmaceutical Supply Chain
Consortium
What is Rx-360 and why should
you get involved?
Protecting patients worldwide
Presented by:
Linda Evans O'Connor, Teva
Scott Watson, AMPAC
HISTORY
2
“Rx-360s current members are pioneers that are building
the type of global, all embracing industry group of the 21st
century. Rx-360 is working to ensure that patients
everywhere can enjoy the benefits of globalization safely.”
Guy Villax, Chief Executive Officer, Hovione
The Problem
3
Rx-360 Mission
To enhance patient safety by developing
a global quality system that helps
members ensure product quality and
authenticity throughout the
pharmaceutical supply chain.
4
Patient safety should never be compromised as a
competitive advantage
“At GSK we are fully supportive of the mission of Rx-360. We particularly
benefit from the Rx-360 joint audit programme, the supply chain security
working groups and the external relations team who do an excellent job of
quickly sharing changes in the regulatory world, as they apply to the
supply chain.” Lynne Byers, VP and Head of Quality Shared Services, GSK
Rx-360: 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
Operating Model
• 501(c)(6) nonprofit organization
• Volunteer based
• Companies are members not individuals
• Not intended to replace regulatory systems or oversight
• Designed to meet competition law requirements
6
Growth in Phases
Phase 1:
Create organizational infrastructure
Phase 2:
Share individual audits and conduct joint
audits
Phase 3:
Fund technological development
7
Broad and Inclusive Membership
• Small and large companies
• Suppliers and manufacturers
• Branded and generic
• Global
• Regulatory agencies, standard setting
bodies, and industry organizations
participate as Observers
8
9
Current Rx-360 Membership
Manufacturers (24)
• Abbott
• Amgen
• Amylin
• AstraZeneca
• Baxter
• Bayer
• Biogen Idec
• Boehringer Ingelheim
• BMS
• Eli Lilly
• Forest Laboratories
• Genentech
• GSK
• Hospira
• Johnson & Johnson
• Merck & Co.
• Merz Aesthetics
• Mylan Inc.
• Novartis
• Pfizer
• Sanofi-Aventis
• Takeda
• Teva
• Watson
Suppliers (30) • AMPAC Fine Chemicals LLC
• Arch Pharmalabs Limited
• Ash Stevens
• Avantor Performance Materials, Inc.
• BASF
• Cambridge Major Laboratories, Inc.
• Cardinal Health
• Chiral Technologies, Inc.
• Doe & Ingalls
• DKSH International
• DSM Nutritional Products Ltd.
• Envirotainer
• Fagron
• GE Healthcare
• Hikal
• Hovione
• ISP
• Labochim
• LifeConEx
• Life Technologies Corp.
• Merck KGaA
• Novozymes
• OSO BioPharmaceuticals Manufacturing LLC
• Sartorius AG
• Sigma Aldrich
• Spectrum Chemical Mfg. Corp.
• TempTime
• VWR
• West
• York Container
Members Observers Auditors (9)
• Auckerman Consulting
• blue inspection body GmbH
• PSC Biotech Corp.
• Regulatory Compliance Associates
• Rephine Ltd.
• RMC Pharmaceutical Solutions Inc.
• Safis Solutions LLC
• SQA Services Inc.
• The Weaver Group, Inc.
Associations (13)
• APIC
• Bulk Pharmaceutical Task Force
• Consumer Healthcare Products Association (CHPA)
• Council for Responsible Nutrition
• European Fine Chemicals Group (EFCG)
• European Generic Medicines Association (EGA)
• IPEC Americas
• IPEC Europe
• NSD Bio Group
• Parenteral Drug Association (PDA)
• Pharmaceutical Supply Chain Initiative (PSCI)
• Pharmaceutical Quality Group (PQG)
• Pharmaceutical Research & Manufacturers of America (PhRMA)
10
Membership/Observer Participation
Continues to Increase
11
Membership Categories
Rx-360 Membership Categories (as of June 2012):
• Manufacturer of pharmaceutical or biotechnology finished products with $500 million
(US dollars)or more in worldwide gross revenue from sales of pharmaceutical or
biotechnology finished products among affiliated entities (“Large Finished Product
Manufacturer”). Dues set at $2,500 per month/$30,000 per year.
• Manufacturer of pharmaceutical or biotechnology finished products with less than
$500million(US dollars) in worldwide gross revenue from sales of pharmaceutical or
biotechnology finished products among affiliated entities(“Small Finished Product
Manufacturer”). Dues set at $1,000 per month/$12,000 per year.
• Contract manufacturer of finished dosage form pharmaceutical and biotechnology
products(“Contract Finished Product Manufacturer”). Dues set at $1,000 per
month/$12,000 per year.
• Supplier of ingredients and components of pharmaceutical or biotechnology products.
Dues set at $500 per month/$6,000 per year.
• Supplier of services relating to the quality or safety of the pharmaceutical or
biotechnology supply chain, including distributors and wholesalers. Dues set at $500
per month/$6,000 per year.
12
13
STRUCTURE
“Rx-360 has brought a truly innovative approach to ensure the highest levels of
pharmaceutical quality and supply chain integrity in the new, globalized
marketplace. By affirming and implementing a shared vision of responsibility
and traceability for their products, Rx-360’s member companies and their
international suppliers are efficiently translating industry best practices to
uncompromisingly pursue the ultimate goals of medicines integrity and patient
safety worldwide.”
Raj Iyer, President, Arch Pharmalabs Limited
14
Current RX 360 Structure
BOARD OF DIRECTORS
Chair – Lynne Byers, GSK
Vice Chair – Al Kentrup, Sandoz
Audit OperationsClare Gosling, AstraZeneca
Darcy Ewalt, Merck & Co., Inc.
DatabaseTeresa Marks, Teva
Al Kentrup, Sandoz
Monitoring and
Reporting Barb Unger, Amgen
MembershipScott Watson, AMPAC
ObserversBoard Liason-TBD
Working Groups as
Needed
Supply Chain
Security Steering
CommitteeBrian Johnson, Pfizer
Tim Valko, Amgen
External and
Regulatory AffairsLynne Byers, GSK
Martin Van Trieste, Amgen
Management SystemsTim Valko, Amgen
Matt Yedwabnick, Amgen
Market MonitoringLew Kontnik, Amgen
Matt Whitt, GSK
Conveyance Risk
ManagementBrad Elrod, Pfizer
Brian Johnson, Pfizer
Audits/Assessments of
Third Party ProvidersDave Campbell, Pfizer
Jeremy Baumann, Takeda
Response to Natural
Disasters
(Japan – T. Valko)
CoordinatorJoint Audits
Auditor Qualification
Shared Audits
Licensing
Finance
Database
Objectives of Current Working Groups
Audit Operations Group
• Manage and oversee the on-going operations of the Rx-360 audit programs (Joint and Shared Audits), including the overall quality management system.
Audit Database Subgroup
• Implement a secure database for storage and retrieval of audit reports, audit responses, and other audit information from the Rx-360 Audit Programs.
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. Limited duration working groups addressing SCS management systems, conveyance risk management, audits/assessments of third party providers, and market monitoring were established.
15
Objectives of Current Efforts
External Relations/Regulatory Affairs
• Facilitate constructive relationships with regulators around the world and keep them informed of Rx-360’s activities and ensure Rx-360’s initiatives are aligned with regulators’ expectations and priorities. Facilitate opportunities for “one to many” meetings to encourage dialogues among groups of regulators on ways to improve supply chain security.
• Develop legal compliance program for Rx-360 communications (e.g., website, flash alerts). Issue Rx-360 communications (e.g., reports, flash alerts, newsletters). Enhance visibility of Rx-360 activities.
Monitoring and Reporting
• Monitor and report on regulatory, policy and legislative developments relevant to supply chain integrity.
Japan Supply Chain
• Share experiences and best practices among industry, regulators and stakeholders, related to the 2011 earthquake/tsunami’s effects on the bio-pharmaceutical supply chain
16
Overview of Audit Programs
17
“BASF supports Rx-360 as it contributes to a secure pharmaceutical
supply chain and enables drug manufacturers and their suppliers to
cope with current and future audit challenges without compromising
product safety.”
Dr. Rainer Fendt, Head of Regulatory & GMP Compliance Pharma , BASF
Rx-360 Shared Audits Program
“Rx-360 is a one-stop venue for understanding the issues, solutions,
and emerging regulations around the pharmaceutical supply chain.
Abbott's participation allows our shared service audit team to apply
enhanced focus and risk prevention with critical suppliers.”
Wes Schmidt, Senior Director, Global Quality Systems, Abbott
19 19
Audit Sharing Concept
• Share reports and responses from audits conducted by individual member companies (not by Rx-360)
• Companies decide individually how to use information in the audit reports/responses
• Suppliers can exclude specific companies (i.e., competitors) from viewing the audit reports/responses – Suppliers can also vet new members joining Rx-360
who have requested access to a Shared audit report
20
Audit Sharing Process: Overview
Sponsor & Supplier
agree to share
audit report/responses
Rx-360 Coordinator reviews
redacted reports/responses and
uploads into database
(documents controlled by CDAs)
Sponsor & Supplier
Redact reports/responses
21 21
Audit Sharing Process: Detail Scope and process described in detail in Audit Sharing SOP
1. Sponsors (pharmaceutical manufacturer members of Rx360) sign a "blanket" confidentiality agreement -- agreeing to participate in the audit sharing program and therefore to share those audit reports with Rx-360 that have been designated by the supplier (Supplemental Confidentiality Agreement).
2. Sponsor contacts supplier(s), introduces the program and asks supplier to identify current or upcoming audit reports to share
3. Supplier signs confidentiality agreement with Rx-360 (Confidential Disclosure Agreement Concerning Audit By Individual Rx-360 Member)
4. Supplier reviews and redacts audit report and responses (according to Redaction Policy)
5. Sponsor reviews (and does any further redaction) of audit report from supplier
6. Sponsor sends final report and responses to Rx-360 Coordinator
7. Supplier has opportunity to tell Rx-360 Coordinator which companies should not have access to the reports/responses in the database (e.g., competitors)
8. Rx-360 Coordinator enters report and responses into database
22
Agreements for Participation in Audit Sharing
Program Accessed through Rx-360 Database
• Membership Supplemental Confidentiality
Agreement
– Between pharmaceutical manufacturer
member or supplier member and Rx-360
• Confidential Disclosure Agreement (CDA)
Concerning Audit by Individual Rx-360
Member
– Between supplier and Rx-360
23
Agreements for Participation in Audit
Sharing Program (Diagram)
Rx-360 Secretariat
Pharma and Suppliers
(Rx-360 Members)
Suppliers
(Rx-360 Members and
Non-members)
Membership Supplemental
Confidentiality Agreement
CDA for Audit by Individual
Rx-360 Member
24
Rx-360 Database Shared Audits Materials
• Quality Management System (Quality Manual)
• Audit Reports and Responses – Shared Audits
• Standard Operating Procedures (SOPs)
• Database protocol
• Signed Agreements
– Membership
– Suppliers
Rx-360 Joint Audit
Program
“At Amgen we have already seen significant benefits from sharing
audit information. We fully support the Rx-360 audit program such
that Amgen will waive the audit of any supplier that has successfully
completed an Rx-360 audit.”
Martin VanTrieste, SVP Quality, Amgen
26 26
Rx-360 Joint Audits Concept (1)
• Audits are sponsored and conducted by Rx-360 on behalf of consortium members
• Rx-360 reviews and hires audit service provider companies to conduct audits
• Suppliers can exclude specific companies (i.e., competitors) from viewing the audit reports – Exclusion is done prior to conducting the audits
– Suppliers can vet:
• New members joining Rx-360 who have requested purchase of a Joint Audit report
• Non-members who have requested purchase of a Joint Audit report
27
Joint Audits Process: Requesting Audits
• Audits are conducted at the request of
members. Rx-360 does not define the
frequency of audits, but does schedule the
audits
• Audits may be requested by
– Pharmaceutical/biotech manufacturer
member to audit a supplier
– Supplier member to audit their own “up-
stream” suppliers
28
Joint Audits Process: Overview Details and expanded flowchart described in Rx-360 Quality Management
System (in Rx-360 Database)
Rx-360 members
request audit
Rx-360 obtains
supplier agreement; selects and
assigns auditor
Auditor contacts supplier;
conducts pre-audit questionnaire;
develops audit plan
Auditor conducts audit and
notifies supplier of observations
during the closing meeting.
Auditor submits audit report
and CAPA plan to Rx-360. Coordinator
forwards report to the Sponsors
Sponsors follow up and close
out CAPA’s. Supplier reports
CAPA follow-ups to Rx-360
Sponsors review report;
Auditor sends final report
and establishes CAPA plan
Rx-360 immediately reports PCO
to Sponsors; Sponsors address PCO
directly with Supplier, separately from Rx-360
Audit Reports stored in
Rx-360 database
Auditor reports any
Potentially Critical Observations (PCO)
to Rx-360 within 24 hours
29
Observations
• Observations in Rx-360 Audit Reports are either “Potentially Critical” or “Other”
• Potentially Critical: – A deficiency that indicates a critical system failure that may
pose an immediate risk to patient safety or health, or may result in adverse impact to the safety, identity, strength or purity of a product. The Potentially Critical Observation should be objectively verifiable based upon documentation, facts, and observations. Each company must assess this observation for Criticality with respect to their product or process
• Other: – A deficiency against the Rx-360 audit standards, guidelines,
checklists, but that are not potentially critical
30
Selection of Auditors
• Rx-360 will only consider auditor service provider firms to conduct Joint Audits – Firms provide oversight and internal selection process and
standard of quality
• Firms can register via Rx-360 Website – http://www.rx-360.org/Membership/Becominga3rdPartyAuditor/tabid/110/Default.aspx
• Rx-360 Coordinator will request bids from registered firms
• Rx-360 Audit Operations WG will review bids and qualifications – Compare against Rx-360 Minimum Requirements for Auditors (in
Rx-360 Database) to develop short list
– Review against expertise of working group members to make final selections
31
Auditor Orientation
• Prior to conducting audits Selected Auditors must – Participate in auditor orientation with Rx-360 subject
matter experts via webconference
– Review all relevant documents on the SharePoint site for Auditors (https://dbrconnect.com/rx360/extranet/default.aspx)
– Sign an Ethics Statement
– Sign a Statement of Understanding upon finishing orientation
– Complete orientation questionnaire (for feedback on quality/effectiveness of orientation) prior to and after audits
32
Guidelines/Standards/Audit Guides
• API and Registered Intermediates
– Guideline and audit guide adopted ICH Q7 with additional TSE/BSE text
• Supply Chain Security
– Audit guide based on review of C-TPAT guidelines and internal company guidelines and practices
• Excipients
– EXCiPACT GMP standard for excipients
– Audit guide based on standard
• Basic Chemicals/Raw Materials (including Chromatography Resins Index)
– Audit Guide based on IPEC/PQG excipients audit guide and draft standard
• Packaging/Printed Materials
– ISO 15378 standard
– Audit Guide based on standard 32
33
Agreements for Joint Audits Program Rx-360 Database
• Membership Supplemental Confidentiality Agreement – Between pharmaceutical manufacturer member or supplier
member and Rx-360
• Audit and Confidentiality Agreement with Supplier – Between supplier and Rx-360
• Service Agreement – Between auditor and Rx-360
– Includes quality agreement
– Includes minimum requirements for auditors
– Includes Ethics Statement
• Statement of Work (with Auditor) – Between auditor and Rx-360
34
Agreements for Joint Audits Program (Diagram) Rx-360 Database
Rx-360 Secretariat
Rx-360 Member
requesting audit
Suppliers
(Rx-360 Members and
Non-members)
Membership Supplemental
Confidentiality Agreement
Service Agreement;
Statement of Work
Audit Service Provider
Audit and Confidentiality
Agreement
35
Costs of an Rx-360 Joint Audit
• The cost of conducting an Rx-360 audit is dependant on the number and type of materials, the location and the number of sponsors.
• The audit costs are equally divided amongst the sponsors. – e.g. $10,000 audit /4 sponsors = $2500 per sponsor
• Audit reports can be purchased upon supplier approval – $2500 members
– $5000 non members
• Money generated from the sale of an report is split equally amongst the sponsors as credit to be used in conducting future audits or purchasing reports.
Potential Savings
36
Note, the pessimistic case assumes 2 co-sponsors of an audit, the base case 5 and the optimistic case
15 co-sponsors
37
Rx-360 Database
• Accessible to Rx-360 members – Only select individuals from each member company
have access to the database.
– The lead representative for an organization approves access rites.
• Managed according to a Database Protocol describing, e.g., – Change management (for the database)
– Security
– Disaster recovery
– Naming conventions
38
Contact Information
• For additional information on the Joint
Audit Program, please contact the Rx-360
Secretariat at [email protected]
Supply Chain Security
39
“Rx-360 is one of the only organizations I know globally that is working on
the issue of supply chain security holistically. Members are collaborating
on audits, sharing intelligence, developing supply chain integrity best
practices, and collectively responding to global events such as the
tsunami in Japan last year. Incredible contributions to the industry and our
patients in a few short years!”
Brian Johnson, Senior Director, Pfizer Supply Chain Security
Objective of Rx-360 Supply Chain
Security Effort
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
40
Scope
• Counterfeiting, theft, adulteration, fraud, and
illegal product diversion
• Key processes to prevent, detect, and respond
• Advocacy and education/awareness
• Materials, manufacturing (internal/external),
transportation, warehousing, distribution, market
monitoring, consumers, reverse logistics
41
Deliverables
• Best practice documents
• Position papers
• Surveys / benchmarking
• Targeted workshops / seminars
• Crisis / threat response
• Regulator / LE interface
• Intelligence sharing
42
Deliverables to Date
1. Management Systems
2. Cargo Theft
3. Market Monitoring
4. Audit/Assessments of Third Party
Providers
• All deliverables available on Rx-360 website.
• All deliverables rolled out with webinars.
• All webinars available on Rx-360 website.
New Working Groups Formed
• Unlawful Diversion
• Management Notification
• Serialization Implementation (discussion
and knowledge sharing group)
44
Accomplishments
“Rx-360 members demonstrated their ability to immediately react to urgent public
health threats in our global supply chains, as evidenced by the immediate
formation of The Japan Supply Working Group and by the specific and actionable
information coordinated and publicly posted by the group, within days of the crisis
in Japan.”
Janice Berman, VP, Takeda Pharmaceuticals U.S.A., Inc.
45
Rx-360 Accomplishments
• US FTC Positive Advisory Opinion supporting
Rx-360 mission, objectives and tactics
• Formal organization established - Governance
process - with advancing membership
• Creating and Endorsement of Standards
– Audit guides, checklist
• Creation and Endorsement of Best practices
– Photographic library
– How to prevent cargo theft
46
Rx-360 Accomplishments
• Nimbly Respond to Supply Chain Threats
– Japan working group
– Glass Quality
• Technology
– Acetonitrile analytical method
• Issued white papers and webinars on Supply Chain
Security Topics:
– Supply Chain Security Management Systems
– Cargo Theft Risk Assessment
– Threats and Monitoring Processes
– Audits and Assessments of Third Party Warehousing and
Distribution Facilities
47
Rx-360 Accomplishments
• Information
– Established a defined "Information Sharing
Mechanism" across broad pharma industry
– Linkage of Suppliers and Manufacturers in a
common arena
– Access to the EDQM supplier database
– Access to the EMA inspection database
48
Rx-360 Accomplishments
• Communication
– 311 News Flash Reports and process for
industry wide messaging
– 90 summaries of proposed or passed
regulation or legislation with an average time
to publish between 6-10 days
– 16 newsletters
– 4 Open meetings
– Numerous Presentations at Meetings and
Conferences
49
Rx-360 Accomplishments
• Has become a regulatory focal point for industry
perspectives - (replaced PhRMA Tech groups
for Regulatory perspectives)
• Recently received approval from IRS as non-
profit entity for tax purposes
50
VALUE PROPOSITION
51
“One of Bayer HealthCare’s strategic goals refers to reliable and
sustainable product supply while ensuring high quality and services for
our customers. Senior management fully acknowledges and endorses
all related activities associated with a secure and transparent supply
chain. Corresponding strong and effective supplier audit programs are
considered as one of the key elements to achieve this goal. Therefore
Bayer HealthCare will take all opportunities related to the Rx-360
activities and deliverables to enhance and further strengthen its
existing audit programs accordingly.”
Thomas Crispin, GMP Audits & Support, Bayer HealthCare
Share Individual Audits and Conduct
Joint Audits
• By collaborating in the two audit sharing programs:
– Members will obtain more information than they do today
about suppliers, allowing more informed decisions to be
made
– Members’ auditing programs will be more efficient allowing
them to evaluate more suppliers annually.
– Suppliers will experience longer but fewer audits, thus
reducing audit fatigue
52
Opportunity to Create, Share, Promote
and Adopt Best Practices, Points to
Consider, and Industry Tools
• Rapid dissemination of information pertaining to the
supply chain via our website, flash reports, LinkedIn,
Twitter and Facebook pages
• Provide summaries of proposed, draft and enacted
legislation and regulation
• Best practices, points to consider and industry tools
examples
– Photographic library; Prevention of Cargo Theft; Audit Standards and
Auditing Guides; Supply Chain Security white papers, tools and
webinars
53
Early Identification and Rapid Response
to Supply Chain Threats
• Early identification of and response to potential
shortages, e.g., acetonitrile
– Allowed members to secure supply
– Developed test method to detect potential adulteration in supply
• Early identification and response to supply chain
threats, e.g., earthquake, tsunami and nuclear
leak in Japan
– Japan Supply Chain Working Group benchmarking, sharing best
practices and working with regulators
54 - continued -
Early Identification and Rapid Response
to Supply Chain Threats
• Early identification of and response to quality issues
in the supply chain, e.g., glass delamination
– Literature review and publication
– Co-sponsor Glass Quality Conference
– Host scientific exchange of information at free round table
discussion
• Conduct surveys and analyze data to provide
benchmarks to the industry
55
Clearinghouse for Supply Chain
Information
• Provide members with an opportunity to
anonymously share with other members and
report suspicious activity in the supply chain to
regulators
56
Working with Regulators to Solve
Problems
• Rx-360 has built a strong reputation with regulators as
being an action oriented, data driven organization
• Rx-360 has met with FDA, SFDA, EMA, WHO, PICs, etc.
• Regulators routinely ask Rx-360 for advice and guidance
• Holds regular open meetings in which regulatory
agencies, standard setting bodies and audit/supply chain
industry organizations participate
57
58
Summary of Benefits of Rx-360
Membership
• Rapidly disseminate supply chain and quality
information
• Identify issues and develop responses 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
• Work with regulators to solve problems
58
Join Rx-360 Today
59
Rx-360 Secretariat
Drinker, Biddle & Reath
+1 (202) 230-5608
For More Information
Questions:
Scott Watson, Rx-360 Membership Committee Chair
AMPAC Fine Chemicals
(205) 641-4422
Linda Evans O'Connor
Senior Director, Quality Compliance
Teva Pharmaceuticals
(201) 930-2252
linda.evans.o'[email protected]