Auditing Service Providers: A Quality Management Process

IATA World Cargo Symposium 2010 Vancouver, Canada March 9, 2010 Arminda Montero Distribution QA Program Manager Global Pharmaceutical Operations, Abbott

Pharmaceutical Distribution Model

Distribution From manufacturing control to supply chain partnerships

Maintain q quality y and efficacy y until use

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End Custo omer Use

Raw Materials

Manufa acturing

From GMPs to GDPs (Good Distribution Practices)

GMPs
(Good Manufacturing Practices)

GDPs
(Good Distribution Practices)

GMPs are not new, they have been in effect for many years and are generally well understood GDPs while an extension of GMPs into the supply chain, are relatively new to supply chain partners, especially to service providers Manufacturers control over the distribution network is much less than within manufacturing but manufacturers may establish quality systems/processes to maintain product quality and efficacy until use

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Good Distribution Practices

Regulations / Guidelines / Standards

Quality Systems
Quality Management Personnel Corrective Action and Preventive Action Complaints and Product Actions Documentation and Change Control Buildings, Facilities and Utilities Equipment Product Design and Development Validation Clinical Research Purchasing Controls Material Controls Production and Process Controls Packaging, Labeling and Promotional Material Controls Laboratory Controls

WHO TRS No. 937 Annex 5 (Working Document QAS/08.252) 21 CFR Part 210, 211, 600 USP 1079 Canada Guide 0069 PDA Technical Report 39 Multiple Worldwide GDP Regulations and Guidelines

Distribution

Cold Chain Management

Maintain product quality and ensure compliance with global regulations and industry standards for the storage, handling and distribution of temperature-sensitive products

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Cold Chain Management Model

Cold Chain Management
Maintain product quality and ensure compliance with global regulations and industry standards for the storage, handling and distribution of temperature-sensitive products

OPERATIONAL PROCESSES PRODUCT REQUIREMENTS Supply Chain Partner Management REGULATORY REQUIREMENTS

Qualification / Validation Ambient p Temperature Profiles

Performance Management

Communication and Education

Continuous Improvement

Storage Temperature Shipping Temperature Temperature Excursions Stability Studies

Passive Shipping Systems

Quality Questionnaires Quality Assessments Temperature Excursion Management Conformance Measurement and Reporting Root-Cause Analysis and CAPA Guidance Documents Training Modules Management Review Meetings Shipping Systems Temperature Monitoring Transportation Industry Trends Regulatory Trends Storage Temperature Shipping Temperature Temperature Excursions Stability Studies

Active Shipping Quality Systems Agreements Chambers Standard Facilities Operating Procedures Periodic Temperature Business Monitoring Review Meetings Distribution Validation Master Plans

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Supply Chain Partner Quality Management

Supply Chain Partners Who?
Suppliers Material Suppliers Service Providers Customers

Quality Management Process What?

Quality Questionnaires Quality Assessments Quality Agreements Standard Operating Procedures Business Review Meetings

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Supply Chain Partners

As appropriate to the business, consider parties involved in the manufacturer to end customer distribution network

Objective

Suppliers Material Suppliers Service Providers Customers

o Packaging Commodities o Shipping Systems o Temperature Monitors/Indicators o Others

o Carriers o Freight Forwarders o Customs Brokers o 3PLs/4PLs o Others o Distributors/Wholesalers o Pharmacies o Others

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Quality Management Process

Evaluate/select appropriate service provider

Objective

Establish roles/responsibilities, service requirements performance management g ( (including g KPIs and and p CAPA) 2
Quality Assessments

1
Quality Questionnaires

3
Quality Agreements

4
Standard Operating Procedures

5
Business Review Meetings

o Evaluation/Selection o Performance Management

o Performance Management

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Quality Questionnaires
Quality Questions may be:

1 Quality Questionnaires

1. Incorporated into Service Provider Evaluation/Selection Business Process ( (Formal Bid Process: RFI / RFP / RFQ) ) Request q For Information
generally includes Service Capabilities, Systems, Quality, Financial Stability, Company Organization)

2. Completed separately from Service Provider Evaluation/Selection Business Process 3. Completed electronically but must include signature of service provider quality representative completing the questionnaire 4. Utilized to assess service provider capability to meet service/quality requirements (focus should be on service provider systems/processes) 5. Utilized as basis for Quality Assessment

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Quality Questionnaires Table of Contents

1 Quality Questionnaires

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Quality Questionnaires Product Storage

1 Quality Questionnaires

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Quality Questionnaires Product Transport

1 Quality Questionnaires

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Quality Assessments
Quality Assessments may be:

2 Quality Assessments

1. Incorporated into Service Provider Evaluation/Selection Business Process ( (Formal Bid Process: RFI / RFP / RFQ) ) Request q For Information
generally includes Service Capabilities, Systems, Quality, Financial Stability, Company Organization)

2. Completed separately from Service Provider Evaluation/Selection Business Process 3. Based on completed Quality Questionnaire 4. Completed during On-Site Visit (Audit); should include Agenda, Report (noting Observations) and Corrective Action Plan 5. Utilized to confirm service provider capability to meet service/quality requirements (focus should be on service provider systems/processes)

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Quality Assessments Areas Covered

2 Quality Assessments

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Quality Assessments Strengths/Concerns

2 Quality Assessments

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Quality Assessments Observations

2 Quality Assessments

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Quality Agreements
Quality Agreements: 1. Define a. roles/responsibilities b. service requirements c. performance management (including KPIs and CAPA)

3 Quality Agreements

2. Signed document between manufacturer and service provider 3. May be incorporated into Service Level Agreement, Technical Agreement, g , Transportation p Guideline, , etc

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Quality Agreements LSPs

3 Quality Agreements

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Quality Agreements TSPs

3 Quality Agreements

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Quality Agreements Customers

3 Quality Agreements

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Standard Operating Procedures

Standard Operating Procedures: 1. Frontline operational instructions

Standard Operating Procedures

2. Written/approved procedure providing instructions for performing operations (generally process-focused, not product specific) 3. Example Outline (Air Freight)
Scope Contact Matrix Escalation Process Process Maps p Detailed Process Instructions (medical emergency shipments, cargo inspection procedures, cargo pick-up requirements, cargo delivery requirements, packaging and temperature requirements, exception handling, weight discrepancies, pre-alert notification, etc) Invoicing Procedures KPIs

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Business Review Meetings

Business Review Meetings:

Business Review Meetings

1. Periodic face-to-face meetings with service provider to review: a. Performance (KPIs, CAPA) b. General Business Updates c. Continuous Improvement Opportunities 2. Example Agenda (Ocean Freight)
Follow-up from previous meeting On-time port-to-port vessel performance Root-causes, corrective actions and trends for vessel non-performance Quarter-to-quarter on-time vessel performance Intermodal performance from source to port of exit Carrier service challenges (i.e. truck, rail or vessel delays, weather delays) Documentation performance (i.e. release bill of lading at origin and destination, bill of lading corrections, freight invoices) Booking performance

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Supply Chain Partner Quality Management Process

Evaluate/select appropriate service provider

Objective

Establish roles/responsibilities, service requirements performance management g ( (including g KPIs and and p CAPA) 2
Quality Assessments

1
Quality Questionnaires

3
Quality Agreements

4
Standard Operating Procedures

5
Business Review Meetings

o Evaluation/Selection o Performance Management

o Performance Management

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Thank you

Arminda Montero Distribution QA Program Manager Global Pharmaceutical Operations, Abbott

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