The document discusses the partnership between Rx-360 and BSI in providing joint audits for suppliers in the healthcare supply chain. It describes how Rx-360 developed audit programs to protect patient safety and share information regarding supply chain integrity. Rx-360 selected BSI as its audit partner due to BSI's experience and commitment to quality in the medical device industry. The joint audit program allows Rx-360 members to request audits and share reports to reduce duplicate audits. BSI ensures auditor qualifications and uses Rx-360 standards and guidelines to conduct audits according to regulatory requirements.

1. The Rx-360 audit programs and BSI
A partnership in supply chain quality and security

2. WES SCHMIDT
Member of the Audit Operations Group (AOG)
AbbVie

3. 3
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

4. The Rx-360 Join Audit Program
In keeping with the Rx-360 Mission, three audit programs
were developed. Today’s focus is on:
1. The Joint Audit Program
2. Audit Report Licensing
3. The Shared Audit Program

5. 55
Rx-360 Joint Audit Program
 Audits are conducted on behalf of members using third
party auditing service providers
 Audit costs are equally divided amongst audit sponsors
 Prior to conducting an audit suppliers can exclude
specific companies (i.e., competitors) from viewing the
audit reports
 Audits may be requested by both manufacturers and
suppliers

6. 666
Key Benefits of Rx-360 Joint Audits
 Reduce the number of audits at a supplier site while
increasing the effectiveness of the audits performed
 Utilize a standardized audit approach and report
template
 Improve transparency of audits and improve ‘collective’
assessment of supplier QMSs
 The report can then be licensed (with supplier approval)
in lieu of conducting an on-site audit

7. Requirements of a Supplier Auditing Program
How Rx-360 meets the fundamental needs
Audit Standards
• Rx-360 Audit
Guidelines are
based on globally
acknowledged
standards for
auditing of
suppliers of
materials and
services
Audit Reports
• Standard audit
report templates
are applied, which
address authority
expectation for the
content of audit
reports, e.g.
according to the
EMA Q&A: GMP.
• Rx-360 Audit
Reports provide a
high level of detail
• Critical information
is immediately
forwarded
Auditor Qualification
• Detailed
requirements for
qualification of
auditors are
established
• Auditor orientation
is provided
• Appropriate
qualification is
verified and
documented for
each individual
auditor;
• Requirements and
documentation
address the
expectations of
authorities, e.g.
according to EMA
Q&A: GMP
Addressing Specific
Needs of Audit
Sponsors
• Audits are planned
prospectively
• Specific aspects to
be covered are
provided to the
auditors in the pre-
audit information
request
• Rx-360 audits
include follow-up of
CAPAs related to
previous sponsor’s
audit
• Beside the Rx-360
audit, suppliers are
still open to receive
customers for
technical visits,
focusing on very
specific issues
without wasting
time for standard
audit topics
CAPA Follow-up
• CAPAs are
evaluated regarding
appropriateness by
the auditors
• CAPA
implementation
follow-up will be
performed until
completion of
actions
• Effectiveness of
CAPAs is verified
during the next
audit
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8. Search for an Audit Partner
• Rx-360 issued an RFP in search of an auditing
firm that meets the level of quality and commitment
needed for this specialized audit program.
• After considering more than a dozen highly
qualified auditing firms BSI was selected for this
engagement.
• Rx-360 has chosen a partner in BSI that has proven its
commitment to patient safety through its extensive work in
the medical device industry.
• With over 70,000 clients worldwide and more than 150,000
audit days in 150 countries per year, BSI has the resources
and infrastructure required to assist Rx-360 with their audit
needs and is perfectly positioned to serve as a partner with
Rx-360 members’ supplier base.

9. Rx-360 Selects BSI
The partnership between the two organizations
was announced…

10. Audit Scheduling
auditsPLUS
In 2014 Rx-360 introduced auditsPLUS, a new custom
audit database
• Members enter audit requests into auditsPLUS
• The database matches like requests
• BSI monitors the database and sends
audit requests to suppliers
• BSI auditors conduct the audits
• The audit is tracked, viewed and made
available to members through the
database
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11. 1111
Audit Guidelines
Current guidelines
API and Registered Intermediates
• Adopted from ICH Q7 with additional TSE/BSE text
Excipients
• Adopted from EXCiPACT GMP standard for excipients
Basic Chemicals/Raw Materials (including Chromatography Resins Index)
• Based on IPEC/PQG excipients audit guide
Packaging/Printed Materials
• Adopted from ISO 15378 standard

12. Additional Audit Initiatives
New Guidelines in Development
Medical Device
Good Distribution Practices (GDP)

13. Supply Chain Security
• Every Rx-360 audit has a Supply Chain Security component
• Standards were adopted from C-TPAT guidelines and internal company
guidelines and practices

14. Observations
• Rx-360 Audit reports use two types of Observations
• 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.
Potentially
Critical
• A deficiency against the Rx-360 audit
standards, guidelines, checklists, but that
are not potentially critical
Other
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15. Joint Audit Process
Rx-360 member
contacts Supplier
asking them to accept
an Rx-360 audit
Rx-360 members enters
audit request into
auditsPLUS
Once minimum number
of sponsors is satisfied,
audit request is sent to
supplier
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 reports any
Potentially Critical
Observations (PCO) to
Rx-360 within 24 hours
Rx-360 immediately
reports PCO to
Sponsors; Sponsors
address PCO directly
with Supplier,
separately from Rx-360
Auditor submits audit
report to Rx-360.
Coordinator forwards
report to the Sponsors
Sponsors review report;
Auditor sends final
report and establishes
CAPA plan
Sponsors follow up and
close out CAPA’s.
Supplier reports CAPA
follow-ups to Rx-360
Audit Reports stored in
auditsPLUS
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16. 16
Agreements for Joint Audits Program
Rx-360 Secretariat
Rx-360 Member
requesting audit
Suppliers
(Rx-360 Members and
Non-members)
Membership
Supplemental
Confidentiality Agreement
Service Agreement;
Statement of Work
BSI
Audit and
Confidentiality
Agreement
Confidentiality - the foundation of the Rx-360 audit programs

17. Member Responsibility
Steps to Adopting the Joint Audit Program Internally
Enter audit requests into the AuditsPLUS
database
Provide input during the pre-audit call about
topics that need to be covered
Formally accept Rx-360 audits for supplier
qualification, update relevant SOPs
Incorporate Rx-360 audit reports into their internal
supplier audit repository/database, assure internal
distribution of reports and results
Perform internal rating of audit observations
Perform specific assessment of the audit
results for the sponsor company and provide
an overall recommendation
Contact the Supplier to request their
participation in the Rx-360 Joint Audit
Program.

18. 18
Rx-360 Audit Licensing Program
• Audit reports originating from the Joint
Audit Program may be licensed to
both members and non-members for
a fee through the Rx-360 Secretariat
• A list of reports available for licensing
can be found on the Rx-360 website
using the following link Rx-360
Reports for Licensing
• Suppliers determine which
organizations may license an audit
report through an addendum to the
original CDA
• Members are provided access to the
reports and corresponding materials
through auditsPLUS
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19. Return on Investment
The Joint Audit Program from a Financial Perpective
Audit of a Member
Company

20. New EU GMPs: Impact to Supplier
Audit Programs at Drug Manufacturers
• Effective 1-March 2015, Law applies to any medicinal products
authorised for marketing in the EU
• Changes are follow-throughs of Falsified Medicines Directive
• New EudraLex Volume 4 updates
• Chapter 5 revisions specific to Active Pharmaceutical
Ingredients
• Supply chain traceability records shall be available [maps]
• Audits should be carried out at manufacturers and distributors of
API’s to confirm GMP/GDP compliance
• The market authorisation holder shall verify compliance either by
himself or through an entity acting on his behalf under contract
• Audit duration and scope commensurate with document risk
assessments
• Repeat audits to ensure maintenance of standards and to verify
approved supply chain [every 3 years]
NEW

21. New EU GMPs: SupplierAudit Programs
• If a Manufacturer outsources the production and/or
distribution of the API, and supplier audits have not been
done routinely or at all:
• They have to be performed now, and on a routine basis
• Audits can be outsourced with appropriate allowances and
controls which may be documented in the manufacturers quality
system
• Providing such items exist, such as:
• Auditing firm has been selected based on competency
• Auditors are deemed competent and trained
• Audit checklists are aligned with scope of audit
• Reports are clear and are good quality records
• Risks can be determined; conclusions [audit ratings, severity]
• Corrective actions can be opened and tracked
• Effectiveness of CAPAs
Oversight: Appropriate actions can be taken
based on findings and inherent risks

22. Return on Investment
The Joint Audit Program from a Financial Perpective
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Audit of a Nonmember Company

23. Summary
• Rx-360 and BSI share a vision of providing high quality
audits
• Working together the audit process can be streamlined
to meet the needs of Rx-360 members while reducing
the number of audits requested of suppliers each year
• Confidentiality is maintained through every step of the
process
• Reports can be licensed, with supplier approval,
through the Rx-360 Secretariat by both members and
non-members, potentially reducing the number of audit
requests
• Audits will remain an important risk management tool
and a demonstration of oversight, as well as a
requirement

24. BEN MILLS
British Standards Institution (BSI)

25. The changing environment in the pharmaceutical sector
Impact on the Supply Chain

26. BSI Expertise
• BSI was the World’s first National Standards Body and Globally recognized
as champions of best practice
• Play a Key Role in Standards Development and Leading Supply Chain Risk
and Compliance Based Solutions.
• Preferred Registrar for 23 of the World’s Top 25 Global Medical Device
Manufacturers
• Leading Supply Chain Risk Management and Compliance Provider to
Pharmaceuticals
• 53% of Leading Global Pharma Companies Utilize BSI
Risk Management and Compliance Services
09/10/2015

27. Audit Experience in High Risk Healthcare
Markets
• Medical Device
• Competence and quality of service is critical
• BSI Delivers >7000 Medical Device Factory Audits Annually to ISO 13485
• Auditing for the US FDA, Japan JPAL, Australia TGA etc
• The Leading EU Notified Body (NB) Delivering Product Conformity
Assessments & Market Access to 28 states
• Circa 75% of the Worlds Leading 100 Medical Device Companies Choose
BSI as their Notified Body
• Supply Chain Risk & Compliance Management
• 53% of Supply Chain Customers are within the Pharmaceutical industry
• Provider to Dept Homeland Security (CBP) with SCREEN intelligence
09/10/2015

28. THE JOINT AUDIT
PROGRAM
The BSI Approach

29. Overview
• Rx-360 Auditor Competency
• Auditor Training
• Rx-360 Audit Standards/Guidance Documents
• Audit Process
09/10/2015

30. Joint Audit Program
• The Joint Audit Program applies to suppliers of:
- Active Pharmaceutical Ingredients and API
Intermediates
- Pharmaceutical Excipients
- Basic Chemicals and Raw Materials
- Pharmaceutical Packaging Materials for Medicinal
Products
09/10/2015

31. 31
Qualification of Third Party Auditors
• They key to a successful audit
program is experienced
auditors
• BSI maintains stringent
guidelines for auditors to be
qualified to conduct audits on
behalf of member.
• All auditors register with the
consortium
• The Rx-360 Audit Operations
Subgroup regularly reviews
auditor qualifications to
ensure they are in keeping
with Rx-360 standards
• Auditors are assigned to an
audit based on qualifications
and location

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Auditor Orientation
Prior to conducting audits all auditors must
1. Participate in auditor orientation with Rx-360 subject
matter experts
2. Review all relevant documents for Auditors
3. Sign an Ethics Statement
4. Sign a Statement of Understanding upon finishing
orientation

33. Rx-360 Auditor Competence
• Education - Bachelor’s Degree in a Science, or Demonstrated
Relevant Work Experience that Provides Equivalent Knowledge
• Professional Experience - Minimum of Five years of GMP
Operational Pharmaceutical Experience and or Similar
Experience. Operational Experience Includes those Skills and
Competencies Gained while Working within a Pharmaceutical
GMP Environment or Equivalent
• Regulatory Knowledge - Must be Knowledgeable about
Pertinent Regulatory and Best-Practices Requirements (e.g.
ICH Q7 for APIs, CFRs for USA, IPEC Guidelines for
Excipients)
• Audit Experience – Applicable Experience in the Types of
Audits Including Leadership
• Auditors are Approved by Subject Matter Expert
09/10/2015

34. Auditor Competency - General
• Auditors are Qualified under ISO 17021 Accreditation Requirements
• Defined Processes are in Place for Selecting, Training, Formally
Authorizing Auditors
• Initial Competence Evaluation of an Auditor includes the Ability to
Apply Required Knowledge and Skills during Audits, as Determined
by a Competent Evaluator Observing the Auditor Conducting an Audit
(Qualifying Review)
• Monitoring Procedures for Auditors includes a Combination of On-Site
Observation, Review of Audit Reports and Feedback from Clients
• Regular Observation on the Performance of Each Auditor On-Site
(Re-qualifying Review)
09/10/2015

35. Auditor Training – Rx-360
• Rx-360 Audit Process Including Guidelines
• Regulatory/GMP (US & EC)
• Supplier Quality Considerations in the Pharmaceutical Industry
• Supply Chain Security
• Regular Refresher Training
• Data Integrity
09/10/2015
NEW

36. Code of Ethics for Rx-360 Auditors
• Integrity
• Objectivity
• Confidentiality
• Competency
• Signed Responsibility Statement
09/10/2015

37. RX-360 Audit Standards/Guidance
Documents
• Rx-360 Audit Standards for Active Pharmaceutical Ingredients
and API Intermediates
• Rx-360 Audit Guide For Pharmaceutical Excipients
• Rx-360 Audit Guide for Basic Chemicals and Raw Materials
• Rx-360 Audit Guide For Pharmaceutical Packaging Materials
for Medicinal Products
• Rx-360 Supply Chain Security Guide for Audits of Excipients,
Raw Materials/ Basic Chemicals, APIs, Repackaging/
Relabeling and Distribution Facilities [Embedded within all
Audits]
09/10/2015

38. Active Pharmaceutical Ingredients and
API Intermediates
• Rx-360 Audit Standards – Document 2460627
• Based on:
• ICH Q7 – Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients, and….
• EMEA/410/01 Revision 2 – October 2003 – Note for
Guidance on Minimizing the Risk of Transmitting Animal
Spongiform Encephalopathy Agents via Human and
Veterinary Medicinal Products
09/10/2015

39. Excipients
• Rx-360 Audit Guide – Document 2577321
• Based on the Entirety of:
• EXCiPACT Certification Standards for Pharmaceutical
Excipient Suppliers: Good Manufacturing Practices
09/10/2015

40. Basic Chemicals and Raw Materials
• Rx-360 Audit Guide – Document 2460023
• Based on the IPEC/PQG Good Manufacturing Practices
Audit Guide for Pharmaceutical Excipients (2007)
• Applies to all Basic Chemicals and Raw Materials Used in
Pharmaceutical Manufacture
09/10/2015

41. Pharmaceutical Packaging Materials
• Rx-360 Audit Guide – Document 2671203
• Based on:
• ISO 15378: “Primary packaging materials for medicinal
products – Particular requirements for the application of
ISO 9001:2008, with reference to Good Manufacturing
Practice (GMP)”
09/10/2015

42. Supply Chain Security
• Rx-360 Supply Chain Security Guide for Audits of
Excipients, Raw Materials/ Basic Chemicals, APIs,
Repackaging/ Relabeling and Distribution Facilities –
Document 2790748
• Based on a Number of Different Documents Including the
C-TPAT Best Practices Guide and Rx-360 Member
Company Internal Documents on Supply Chain Security
• Used in Conjunction with the Rx-360 Audit
Standards/Guidelines that Address the GMP/Quality
Assurance Topics
09/10/2015

43. Rx-360 Audit Process
• Pre-Audit Questionnaire Provides Information to Assist Audit
Planning and Background Information for the Final Report
• Audit Plan Template Gives the Outline Plan for the Audit.
• Special Requests from Sponsor(s) Need to be Covered as
Appropriate During the Audit while Maintaining Confidentiality
between the Sponsors
• The Audit is a Comprehensive Evaluation of the Auditee’s
Ability to Produce/Provide Materials/Services Compliant with
cGMP and/or other Designated Regulatory Requirements
• The Audit Encompasses all Key Aspects of Supply Chain
Security Auditing
09/10/2015

44. Audit Observations
• Observations are Classified as “Potentially Critical or “Other”
• A Potentially Critical Observation is:
“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”
• If a Potentially Critical Observation is identified during an Audit
must Notify Rx-360 Member Company Sponsors within 24
hours
• Definition of “Other” – an Observation which is not Potentially
Critical.
• Note: Sponsors Manage “Other” Observations According to
their Individual Management System Requirements.
09/10/2015

45. Rx-360 Audit Process – Opening/Closing
Meeting
• Opening Meeting:
• An opening meeting setting the audit process is outlined
• Closing Meeting:
• Review of any observations (including potentially critical
observations) arising during the audit
• Observations presented on a specific form
• Observations listed in order of their significance
• The full audit report is not issued at the time of the audit. The
audit report is reviewed internally within BSI and then goes
through a review process with RX-360 prior to final issue
09/10/2015

46. Rx-360 Audit Process – Reporting &
CAPA Management
• Specific RX-360 Report Templates are used
• BSI Report Review Process Ensures consistency, compliance
and accuracy of reports and drives continual improvement (e.g.
future training considerations)
• Report Review Process with Rx-360 and Sponsors Prior to
Final Issue
• BSI Agrees CAPA Plan with the Supplier
• BSI Submits the plan to the Audit Sponsors and Rx-360
09/10/2015

47. The Elephant in the Room

48. Can We Implement the Rx-360Audit Program?
• Through VOC, we have built a program that works
• Initial points of perceived resistance:
• Quality issues
• Staffing issues
• Regulatory reception
• Budget

49. VOC: What Level of Quality Can We Expect?
• The report format has been created to capture the
complete compliance picture
• Observations have been vetted with Supplier
• CAPA responses are included
• Sponsors review for clarification

50. The Rx-360 Audit Report & CAPA
Adetailed response

51. VOC: We Have an Internal Audit Program
• The Rx-360 Audit Program can supplement your audit
program
• Multiple sponsors can increase opportunity of audit
• BSI has global presence of FTE staff
• Internal staff are freed up to address internal supplier
projects/issues

52. VOC: Will regulators accept audits conducted
using third party auditors?
“FDA is very much in favor of industry’s
cooperative efforts, such as Rx-360…”
Rick Friedman
…This should normally provide sufficient assurance that
the results of an audit carried by the third party are
credible thus waiving the need for an audit conducted
by the manufacturing authorization holder itself….

53. More from Regulators
API audits by 3rd Party Auditors are regarded as suitable by MHRA on the
following basis:
• The scope of the audit must be clearly defined and must include
appropriate/defined elements of the supply chain.
• Auditors must be appropriately qualified.
• A 3rd party auditor may provide audit reports to multiple Manufacturing
Authorisation holders. Manufacturing Authorisation holders may make use
of such a report as far as the scope is fully pertinent to the APIs in
question.

54. Budget
• Co-sponsors pay reduced audit fees
• Internal travel costs are reduced
• Licensing can reduce future audit costs

55. Built for Success
• The program was designed to be easily implemented
• The program is scalable
• The database is user friendly, and allows visibility
• Multiple staff can have database access

56. A Success Story
• One of the world’s top biotech manufacturers has turned
over all audits to Rx-360
• Internal study showed significant savings over using
100% internal auditors
• Internal staff allowed to focus more on supplier quality
issues and relationship building
• Yearly audit budget has been reduced
• Reports and requests are managed to manufacturer’s
satisfaction

57. Business Case
• The Rx-360 Audit Program:
• Reduces audit costs
• Provides control and visibility
• Is scalable to individual needs
• Is accepted by regulators world wide
• Helps to secure difficult supplier audits
• Is managed by a world leader in compliance auditing
• Reduces supplier’s audit time, providing more time for customer
care
• Helps industry meet changing regulatory requirements

58. Three steps to developing a competitive advantage

59. BSI Commitment to RX 360
• Good momentum to date, currently managing the delivery of over 150 audits
• Collaborative working relationship between BSI and the Audit Operations Group (AOG)
• BSI is committed to raising the awareness and supporting the RX 360 program on
multiple levels
• Supported Paris and Cologne meetings
• Webinar series
• Roadshows
• Promotional materials
09/10/2015

60. Contact Information
For further information on Rx-360 and the audit programs, please
contact Kristin Colley Krisko of the Rx-360 Secretariat using the
information below.
Kristin Colley Krisko
Rx-360 Secretariat
www.rx-360.org
1500 K Street, N.W., Washington, DC 20005-1209
phone: +1 (202) 230-5921 e-mail: kristin.colleykrisko@dbr.com
*Secretariat, Drinker Biddle & Reath LLP