The Rx-360 audit programs and BSI

A partnership in supply chain quality and security

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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

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

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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

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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

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Qualification of Third Party Auditors

• They key to a successful audit program is experienced auditors

• Rx-360 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

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 highlyqualified 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.

Rx-360 Selects BSI

The partnership between the two organizations

was announced>

Audit SchedulingauditsPLUS

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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Audit GuidelinesCurrent 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

Additional Audit InitiativesNew Guidelines in Development

Medical Device

Good Distribution Practices (GDP)

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

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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Joint Audit Process

Rx-360 member contacts Supplier

asking them to accept an Rx-360 audit

Rx-360 member contacts Supplier

asking them to accept an Rx-360 audit

Rx-360 members enters audit request into

auditsPLUS

Rx-360 members enters audit request into

auditsPLUS

Once minimum number of sponsors is satisfied, audit request is sent to

supplier

Once minimum number of sponsors is satisfied, audit request is sent to

supplier

Rx-360 obtains supplier agreement; BSI

coordinator selects and assigns auditor; auditor

contacts sponsor for audit scope

Rx-360 obtains supplier agreement; BSI

coordinator selects and assigns auditor; auditor

contacts sponsor for audit scope

BSI coordinator contacts supplier; conducts pre-audit

questionnaire; develops audit plan

BSI coordinator contacts supplier; conducts pre-audit

questionnaire; develops audit plan

Auditor conducts audit and notifies supplier of observations during the

closing meeting

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

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

Rx-360 immediately reports PCO to

Sponsors; Sponsors address PCO directly

with Supplier, separately from Rx-360

Auditor submits audit report and

corresponding documents to auditsPLUS

Auditor submits audit report and

corresponding documents to auditsPLUS

Sponsors review report; Auditor sends final

report and establishes CAPA plan

Sponsors review report; Auditor sends final

report and establishes CAPA plan

BSI follows up and closes out CAPA’s.

Supplier reports CAPA follow-ups to Rx-360

BSI follows up and closes out CAPA’s.

Supplier reports CAPA follow-ups to Rx-360

Audit Reports and CAPAs stored in

auditsPLUS

Audit Reports and CAPAs stored in

auditsPLUS

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6

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3

2

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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

Requirements of a Supplier Auditing ProgramHow 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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Member ResponsibilitySteps 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.

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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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Return on InvestmentThe Joint Audit Program from a Financial Perpective

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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