1. Rx-360 in Action:
An inside look at the Joint Audit Program
www.Rx-360.org
Gerard Pearce
Executive Vice President
SQA Services, Inc.
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

2. Today
Supply
Chain
Pilot Security
Shared
Audit
Audits
Program
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

3. The problem
May 7, 2007
80 children die in Haiti due to contaminated
glycerin in acetaminophen syrup
3
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

4. 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.
Patient safety should never be compromised as a competitive
advantage
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

5. Rx-360 Aims
1. To exchange public information to allow firms to adopt
best practices.
2. To act as a clearinghouse for suspicious supply chain
information.
3. To share individual audits and conduct joint audits.
4. To consider joint technological development for
securing supply chain and detecting adulteration.
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

6. Growth in Phases
1: Create organizational infrastructure
2: Share individual audits and conduct joint audits
3: Fund technological development
Rx-360 Working Groups
• Audit Design (Rx-360 Joint Audits) • Audit Database
• Auditor Qualification (Rx-360 Joint Audits) • Regulatory Affairs
• Audit Standards (Rx-360 Joint Audits) • External Relations
• Audit Sharing (Sharing of Individual Audits) • Monitoring and Reporting
• Rx-360 Quality Management System • Japan Supply Chain Threat
• Various Supply Chain, Security and Logistics
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

7. Current Status of Rx-360
• Rx-360 was incorporated on June 3rd 2009
• Currently over 65 organizations globally have
joined Rx-360 as members or observers
• Several meetings have taken place with
regulators (EMA, FDA, WHO & PIC/S)
• FTC staff have reviewed Rx-360 proposed
auditing programs and issued favorable opinion
regarding antitrust legal compliance
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

8. Rx-360 Membership Now Tops 65!
Members Observers
Manufacturers (24) Suppliers (24) Auditors (6)
• Abbott • AMPAC Fine Chemicals LLC • PSC Biotech Corp.
• Amgen • Arch Pharmalabs • Regulatory Compliance Associates
• Amylin • Avantor Performance • RMC Pharmaceutical Solutions Inc.
• AstraZeneca Materials • Safis Solutions LLC
• Baxter • BASF • SQA Services Inc.
• Bayer • Doe & Ingalls
• The Weaver Group, Inc.
• Biogen Idec • DSM Nutritional Products
• Boehringer Ingelheim Ltd.
• Bristol-Myers Squibb • Fagron Associations (10)
• Cephalon • GE Healthcare • APIC
• Eli Lilly • Hikal • Council for Responsible Nutrition
• Forest Labs • Hovione • Consumer Healthcare Products Ass (CHPA)
• Genentech • ISP • European Fine Chemicals Group (EFCG)
• GlaxoSmithKline • Labochim • European Generic Medicines Association
• Hospira • LifeConEx (EGA)
• Johnson & Johnson • Life Technologies • IPEC Americas
• Merck & Co., Inc. • Merck KGaA • IPEC Europe
• Mylan • Novozymes
• NSD Bio Group
• Novartis • OSO BioPharmaceuticals
• Pfizer • SICPA Holding
• Parenteral Drug Association (PDA)
• sanofi-aventis • Sigma Aldrich • Pharmaceutical Quality Group (PQG)
• Takeda • Spectrum Chemical &
• Teva Laboratory Products
• Watson • TempTime
• VWR
• West
• York Container
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

9. Sharing Supplier Audits Will Increase
Compliance, Quality and Efficiency
Approaches being developed are:
1. Rx-360 Joint Audits are initiated by the consortium
based on input from all members
2. Audit sharing uses existing audits that are redacted
and placed into a secure database for member
access
Numerous 1 or 2 day audits of a supplier will be replaced with fewer but
more thorough Rx-360 Joint Audits, thus eliminating “Audit Fatigue”
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

10. Rx-360 Joint Audit Standards
• Identify and adopt existing audit standards /
guidelines
• Identify gaps where existing audit standards /
guidelines do not exist and develop Rx-360 audit
standards to fill those gaps
• Continuously refine after successful
implementation
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

11. Rx-360 Joint Audits
Audit Conduct Review Ongoing Decision
Planning Audit Proposed Update Making
CAPAs
To Rx-360 Auditor / Share info
Rx-360
Coordinate reviewers
plans audit provided by
standards opine on supplier
adequacy
Request audits Individually Review Independent
decide on
Individual
information decision making
Members
acceptability
for product/ on use of
Separately company supplier/material
manage applicability
product
specific
concerns
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

12. Pilot Audit Program
Audit Design Working Group (ADWG)
Objective: Design an Rx-360 sponsored system for voluntary joint
audits of suppliers using agreed-upon quality and audit standards
• Three qualified third-party Auditors
• Focused on US, EU and Asia (19 total)
• ‘Stress Test’ on process, tools and training
• Commodity-based Guidelines plus Security
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

13. Guidelines/Standards/Checklists
• API and Registered Intermediates
– Adopted ICH Q7
– Additional TSE/BSE text
• Supply Chain Security
– Based on review of C-TPAT guidelines and internal company
guidelines and practices
• Excipients
– Adopted IPEC/PQG excipients audit guide and standard
• Basic Chemicals/Raw Materials
– Based on IPEC/PQG excipients audit guide and draft standard
• Packaging/Printed Materials
– In development
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

14. Supply Chain Security Checklist
1. Premises
2. Quality Management System
3. Incoming Shipments
4. Manufacturing
5. Packaging/Repackaging and/or Relabeling
6. Distributors
7. Outgoing Shipments
8. Information Technology Security
9. Documents
10.Organization and Personnel Awareness
11.Planning and Management
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

15. The SQA Experience
• Supplier coordination & communication
• No ‘Criticals’
• Tools and preparation
• Variation in results format and style
• Exceptions and escalation
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

16. Pilot Debrief with all Auditors
• Consistent experiences in all areas
• Orientation and Training – to evolve with the tools
• Standards – application and adaptation
• Forms – refinement
• Conduct of the Audit – cautiously positive
• Audit Report Review Process – timing, confidentiality
• Corrective and Preventative Actions – review, escalation
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

17. Pilot Next Steps
• Close out all Pilot activity
• Consolidate and act on feedback
• Report to Rx-360 Membership
• Post-pilot Audit Request Form ‘live’, with
Q4 audit requests already received
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

18. Thanks and Questions
Gerard Pearce
gpearce@sqaservices.com
310-802-4448
Supply
Chain
Pilot Security
Shared
Audit
Audits
Program
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

19. Supplementary slides
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

20. Operating Model
• 505(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
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

21. Broad and Inclusive Membership
• Small and large companies
• Branded and generic
• Based in US, Europe, and elsewhere
• Suppliers and manufacturers
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

22. Current Rx-360 Working Groups
• Audit Design (Rx-360 Joint Audits)
• Auditor Qualification (Rx-360 Joint Audits)
• Audit Standards (Rx-360 Joint Audits)
• Audit Sharing (Sharing of Individual Audits)
• Audit Database
• Rx-360 Quality Management System
• Regulatory Affairs
• External Relations
• Monitoring and Reporting
• Various Supply Chain, Security and Logistics
• Japan Supply Chain Threat
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

23. Objectives of Current Working Groups
Audit Design
• Design an Rx-360 sponsored system for voluntary joint audits of
suppliers using agreed upon quality and audit standards.
Auditor Qualification
• Identify and agree the relevant auditor qualifications, background,
and experience necessary for the performance of supplier GMP and
quality audits within the Rx-360 auditing program. Identify auditing
certification/accreditation programs and compare the requirements
under these programs for certification/accreditation to the identified
Rx-360 minimum requirements for auditors. Identify a list of auditing
service providers and compare their auditor qualifications to the
identified Rx-360 minimum requirements for auditors. Make
recommendations to the Rx-360 Board on the process for selection
of Rx-360 auditors.
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

24. Objectives of Current Working Groups
Audit Standards
• Identify existing manufacturing quality standards for pharmaceutical
suppliers of raw materials, excipients, APIs, and packaging
components (including printed components). Identify gaps in
standards for which additional guidelines are required, e.g., auditing
the security aspects of the supply chain. Make recommendations to
the Board on standards to which Rx-360 audits should be
conducted.
Audit Sharing
• Develop and pilot a process to share audit reports among
consortium members for audits that were originally conducted on
behalf of individual members.
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

25. Objectives of Current Working Groups
Audit Database
• Implement a secure database for storage and retrieval of audit
reports, audit responses, and other audit information from the Rx-
360 Audit Programs.
Quality Management Systems
• Design and manage the overall quality systems for Rx-360,
including for the Rx-360 joint auditing and audit sharing programs.
Provide oversight of the overall effectiveness of the quality systems
supporting Rx-360, including evaluating effectiveness checks
applicable to the Rx-360 quality systems.
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

26. Objectives of Current Working Groups
Regulatory Affairs
• Facilitate constructive relationships with regulators around the world
and keep them informed of Rx-360’s activities. Ensure that 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.
External Relations
• 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.
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011

27. Objectives of Current Working Groups
Japan Supply Chain Threat
• This working group is identifying risks as a result of the Japanese
earthquake, tsunami, power interruptions and nuclear power plant
accidents. They have identified methods to mitigate risks and are
sharing best practices to help ensure pharmaceutical supplies in
Japan and the safety of materials and pharmaceuticals exported
from Japan.
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011