pda southern california rx 360 pilot update
TRANSCRIPT
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
Rx-360 in Action: An inside look at the Joint Audit Program
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Gerard PearceExecutive Vice PresidentSQA Services, Inc.
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
Today
Supply Chain
SecurityShared Audits
Pilot Audit
Program
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
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May 7, 200780 children die in Haiti due to contaminatedglycerin in acetaminophen syrup
The problem
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
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
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
Growth in Phases
1: Create organizational infrastructure
2: Share individual audits and conduct joint audits
3: Fund technological development
• Audit Design (Rx-360 Joint Audits)• Auditor Qualification (Rx-360 Joint Audits)• Audit Standards (Rx-360 Joint Audits)• Audit Sharing (Sharing of Individual Audits)• Rx-360 Quality Management System• Various Supply Chain, Security and Logistics
• Audit Database• Regulatory Affairs• External Relations• Monitoring and Reporting• Japan Supply Chain Threat
Rx-360 Working Groups
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
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
Rx-360 Membership Now Tops 65!
Manufacturers (24)• Abbott• Amgen• Amylin• AstraZeneca• Baxter• Bayer• Biogen Idec• Boehringer Ingelheim• Bristol-Myers Squibb• Cephalon• Eli Lilly• Forest Labs• Genentech• GlaxoSmithKline• Hospira• Johnson & Johnson• Merck & Co., Inc.• Mylan• Novartis• Pfizer• sanofi-aventis• Takeda• Teva• Watson
Suppliers (24)• AMPAC Fine Chemicals LLC• Arch Pharmalabs • Avantor Performance
Materials• BASF• Doe & Ingalls• DSM Nutritional Products
Ltd.• Fagron• GE Healthcare• Hikal• Hovione• ISP• Labochim• LifeConEx• Life Technologies• Merck KGaA• Novozymes• OSO BioPharmaceuticals• SICPA Holding• Sigma Aldrich• Spectrum Chemical &
Laboratory Products• TempTime• VWR• West• York Container
Auditors (6)• PSC Biotech Corp.• Regulatory Compliance Associates• RMC Pharmaceutical Solutions Inc.• Safis Solutions LLC• SQA Services Inc.• The Weaver Group, Inc.
Associations (10)• APIC• Council for Responsible Nutrition• Consumer Healthcare Products Ass (CHPA)• European Fine Chemicals Group (EFCG)• European Generic Medicines Association
(EGA)• IPEC Americas• IPEC Europe• NSD Bio Group• Parenteral Drug Association (PDA)• Pharmaceutical Quality Group (PQG)
Members Observers
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
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
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
Rx-360 Joint AuditsR
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Mem
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Decision Making
Ongoing Update
Review Proposed CAPAs
Conduct Audit
Audit Planning
Coordinate plans
Request audits
To Rx-360 audit standards
Auditor / reviewers opine on adequacy
Share info provided by supplier
Individually decide on acceptability
Separately manage product specific concerns
Review information for product/ company applicability
Independent decision making on use of supplier/material
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
Pilot Audit Program
• 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
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
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
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
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
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
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
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
Thanks and Questions
Supply Chain
SecurityShared Audits
Pilot Audit
Program
Gerard [email protected]
310-802-4448
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
Supplementary slides
PDA Southern California Chapter – Supply Chain Security in the Pharmaceutical Industry – August 30, 2011
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
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
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
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
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
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
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
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.