Quality Agreements Presentation _
Compliance Surety Associates2008 AAPS Annual Meeting and Exposition • Atlanta, GA
Quality AgreementsA cGMP Perspective
Presenters: Jim McAndrewVice President - PharmPro ServiceAurora, Illinois
Ralph DillonDirector, Compliance Surety AssociatesLincolnwood, Illinois
Sunrise Session – Tuesday, November 18th
Quality Agreements Presentation _
Compliance Surety Associates2008 AAPS Annual Meeting and Exposition • Atlanta, GA
Quality Agreements Presentation
Compliance Surety Associates
Quality AgreementsA cGMP Perspective
Presenters: Jim McAndrewVice President - PharmPro ServiceAurora, Illinois
Ralph DillonDirector, Compliance Surety AssociatesLincolnwood, Illinois
Sunrise Session – Tuesday, November 18th
Quality Agreements Presentation _
Compliance Surety Associates
• Quality Agreements -What are They, When and How Do We Use Them? .....and Why do we need them? (Are you ready to answer these questions well enough for top management?)
Ralph Dillon
Quality Agreements
• Quality Agreements -A critical tool to assure cGMP Compliance & simplify business
Jim McAndrew
Quality Agreements Presentation _
Compliance Surety Associates
Do I Need a QualityAgreement with my Service
Provider?
Quality Agreements Presentation _
Compliance Surety Associates
You should consider a Quality Agreement if…
You’re going to produce commercial or clinical materials
You expect your data to be pivotal or reviewed by the agency
You expect that the supplier’s facility will be part of a Pre-Approval Inspection
Quality Agreements Presentation _
Compliance Surety Associates
You should consider a Quality Agreement if
your project requires your contractor to…
Perform activities outside the scope of theircore competency;
Coordinate critical path activities with other contractors or service providers.
Quality Agreements Presentation _
Compliance Surety Associates
A Quality Agreement is probably not necessary if…
The activities you require your contractor to provideare part of the routine suite of services they provide;
And your project does not require close coordinationto achieve success;
And your project does not require GMP processingor submittable data sets.
Quality Agreements Presentation _
Compliance Surety Associates
Five Benefits of a Quality Agreement
Accountability
Risk Management
Communications
Coordination & Planning
Compliance
Quality Agreements Presentation _
Compliance Surety Associates
Clearly Establish Responsibilities between parties
Determine damage resolutions before they’re needed
Quality Agreement Benefits Accountability
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreement Benefits Risk Management
Encourages all parties to analyze project for potentialHazards and risks.
Focuses parties on hand off points where mostFailures occur.
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreement Benefits Coordination & Planning
Encourages all parties to plan the project through to conclusion.
Focuses parties on hand off points where mostFailures occur.
Exposes parts of the project that may have been overlooked or are outside the scope of participantcapabilities.
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreement Benefits Compliance
Expressly outlines Quality Responsibilities to Ensure final compliance.
Coordinates the efforts of the Sponsor’s QualityUnit with the efforts of the Contractors Quality Unit.
Assures the Sponsors Quality Unit understands thework load associated with the project.
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreement Benefits Communications
Encourages communication between Quality UnitsAnd Regulatory Units.
Coordinates all Stake Holders.
Provides a tool for universal communication of Critical Quality Responsibilities and Actions to eachmember of the Project Team.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Regulatory and GMP Compliance
•Generally requires all parties maintain licenses and comply with regulations concerning marketing and manufacturing drugs
•Establishes who will file the Annual Product Review with the FDA
•Formalizes what records will be regularly shared between parties
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Regulatory Actions and Inspections
•Establishes that each party will notify the other of any agency inspections, seizures, or other actions.
•Requires all contractors to provide copies of 483’s and responses to Sponsor’s Quality Unit.
•Sets forth how Sponsor and Contractor will coordinatebefore, during, and after inspections.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Specifications, Authorizations, and Change Control
•Sets forth who will draft, review, and approve MasterBatch Records and who will review and approve changes to the Master Batch Record
•Sets forth who will review, and approve any proposed changes to the Product Specification.
•Requires that contractors will notify Sponsor of andchanges to manufacturing or analytical equipment orfacilities which may impact the product.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Material Handling and Testing
•Establishes who will source materials and qualify suppliers.
•Sets forth who will test and release materials, as well as who will maintain reserve samples.
•Requires that contractors dispose of waste and setsforth any requirements (environmental or otherwise)regarding same.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?Production and Validation•Establishes who’ll draft, review, execute, and approve process validation protocols.
•Provides for oversight of validation activities by the drug sponsor.
•Requires contractors to manufacture, package and test per the specifications and validated methods and maintain the validations as current.
•Requires the documentation, investigation, and communication of deviations and out of specification results.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Audits
•Provides for the right of the drug sponsor to conduct quality audits and sets limits on the frequency of such audits.
•Requires contractors to self audit periodically and may provide for the sharing of such audit results with the drug Sponsor.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Release
•Establishes which Quality Unit will be responsible forfinal release and any in-process release required.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Records
•Coordinates the generation, sharing, and storage of process and analytical records.
•Establishes what records will be routinely duplicatedand shared between parties and how that will be accomplished.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Storage
•Lays out specific storage requirements for raw and finished materials (by reference to specification)
•Ensures required hold time limits are observed.
•Establishes limits for warehousing of raw and finishedmaterials (both quantities and duration)
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Safety
•Requires an occupational safety program tobe maintained by contractors.
•Sets out occupational/environmental risks (if any) and required steps to mitigate those risks.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Complaints
•Sets forth how contractors will handle quality complaints from the Sponsor.
•Sets forth how contractors will coordinate with the Sponsor to investigate complaints from the consumer.
•Establishes which party has the responsibility to liaise with the FDA regarding complaint investigation.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Recall, Field Alerts, and Product Withdrawal
•Determines who has the responsibility to issue or follow up on Recalls, Field Alerts, and ProductWithdrawals.
•Sets forth who will liaise with the FDA on Recalls,Field Alerts, and Product Withdrawals.
•Requires contractors to provide records and technicalexpertise in support of Recalls, Field Alerts, or ProductWithdrawals.
Quality Agreements Presentation _
Compliance Surety Associates
What Should A Quality Agreement Cover?
Returns
•Determines who handles product returns.
•Determines what information will be shared between parties in regard to retuned product.
Quality Agreements Presentation _
Compliance Surety Associates
Commercial vs. Clinical Quality Agreements
Quality Agreements put in place for Clinical Projects are Subsets of Commercial Quality Agreements.
Drop the Market Oriented sections such as Complaintsand Recalls.
Pay closer attention to Records, Storage, and InspectionsSections.
Quality Agreements Presentation _
Compliance Surety Associates
Features of Effective Quality Agreements
Multilateral
Clear
Simple
Comprehensive
Quality Agreements Presentation _
Compliance Surety Associates
Features of Effective Quality Agreements - Simplicity
Plain English – not Lawyer Speak
Use terms common to all parties
Don’t be verbose or tedious
Quality Agreements Presentation _
Compliance Surety Associates
Features of Effective Quality Agreements - Clarity
Organized, Easy to Grasp Format
•Checklist by Activity Category
•Activities by Department
•Timeline of Activity
Quality Agreements Presentation _
Compliance Surety Associates
Features of Effective Quality Agreements - Multilateral
Every Player should Participate
The process should be transparent to Non-decision makers
Quality Agreements Presentation _
Compliance Surety Associates
Features of Effective Quality Agreements - Comprehensive
Every project has a set of responsibilities and hurdles it is likely to face.
Agreement value is maximized when the agreement covers all the eventualitiesthe project is likely to face, and no more
Cover enough, but nothing more!
Quality Agreements Presentation _
Compliance Surety Associates
Features of Effective Quality Agreements - Comprehensive
Eventualities / Responsibilities
Valu
eNumber of Likely EventualitiesFaced by your project
Agreement Value Maximized
Quality Agreements Presentation _
Compliance Surety Associates
Visibility throughout the Organization
The most important Feature of a Successful Quality Agreement
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety AssociatesQuality Agreements Presentation _
Compliance Surety Associates
Quality Agreements -What are They, When and How Do We Use
Them? .....and Why do we need them?
(Are you ready to answer these questions well enough for top
management?)
Quality Agreements Presentation _
Compliance Surety Associates
• Quality Agreements -What are They, When and How Do We Use Them? .....and Why do we need them? (Are you ready to answer these questions well enough for top management?)
Ralph Dillon
Quality Agreements
• Quality Agreements -A critical tool to assure cGMP Compliance & simplify business
Jim McAndrew
Lesson: Without Agreement,
Results may not meet
Expectations!
Quality Agreements Presentation _
Compliance Surety AssociatesQuality Agreements Presentation _
Compliance Surety Associates
Quality Agreements
#1 Document to coordinate quality of product
Quality Agreements Presentation _
Compliance Surety Associates
Product Surety Initiative
WHOAnti-Counterfeiting Forum
Cambridge University
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety Associates
• A Quality Assurance / Quality Control based consultancy
• Focused on the high value services for remediation and new facility/new drug approvals from the FDA, EMEA, and World Health organizations
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Quality Agreements Presentation _
Compliance Surety Associates
About the Organisation:
Quality Assurance is the only function that touches product from the earliest moments of discovery all the way through customer use.
It has been effectively underwriting corporate risk since the advent of GxP’s in the 1970s. Proactive Quality solutions and focused strategic integration will define
success in the changing landscape of the future.
Compliance Surety Associates focus globally on:• Strategic Planning for quality compliance• Identification, risk quantification and risk reduction programs• Supply Chain Defence and proactive crisis management
Compliance Surety Associates focus locally on:• Proprietary meta-tools for effective inspection management• Product Development and Facility Readiness Assessments• Product Development Strategies
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Quality Agreements Presentation _
Compliance Surety Associates
Unique Core Capabilities for Fast Track Approvals
• FDA & EMEA inspection experience
• Analysis & remediation
• Big Pharma Hypertrack Roll-out experience
• Mechanical & engineering support to direct physical activities
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Quality Agreements Presentation _
Compliance Surety Associates
ChicagoOverall Program Management
New Facility Start-up & approvalQuality Assurance Support
Validation Engineering
Sao PauloEngineering
New process Start-up
Rio de Janiero Engineering
New process Start-up
Washington DCRegulatory Support office
New drug submissionsClinical Program Management
SydneyNew process Start-up
Validation
Newcastle, UK QP - Qualified Person
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Compliance Surety AssociatesQuality Agreements Presentation _
Compliance Surety Associates
Quality Agreements
#1 Document to coordinate quality of product
Quality Agreements Presentation _
Compliance Surety AssociatesQuality Agreements Presentation _
Compliance Surety Associates
Quality Agreements
#1 Document to coordinate quality of product
At a minimum ADD …….Call Lists
--- Include mobile phones & home numbers
--- List alternate contacts
--- Clearly define roles &/or responsibilities
Quality Agreements Presentation _
Compliance Surety AssociatesQuality Agreements Presentation _
Compliance Surety Associates
Quality Agreements
#1 Document to coordinate quality of product
At a minimum ADD…….Call Lists
For complex supply chains – ADD Quality Release Maps
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety AssociatesQuality Agreements Presentation _
Compliance Surety Associates
Quality Agreements –Why do we need
them ?
• Attorney’s and contract administrators don’t understand “quality” regulation and industry practice the same way as Quality people
– Example: The $100 million purchase order (Celebrex)
Quality Agreements Presentation _
Compliance Surety Associates
What is
“bad” or “good” and who
defines it?
Quality Agreements Presentation _
Compliance Surety AssociatesQuality Agreements Presentation _
Compliance Surety Associates
Quality Agreements –Why do we need
them ?
• Attorney’s and contract administrators don’t understand “quality” regulation and industry practice the same way as Quality people
– Example: The $100 million purchase order (Celebrex)
• Clearly defines quality responsibilities by both parties
• Programmed Resolution of issues
• Time and responsibilities – (Keeping out politics)
• Minimizes redundant efforts
Quality Agreements Presentation _
Compliance Surety Associates2008 AAPS Annual Meeting and Exposition • Atlanta, GA
Quality Agreements –Why do we need
them ?
• Attorney’s and contract administrators don’t understand “quality” regulation and industry practice the same way as Quality people
– Example: The $100 million purchase order
• Clearly defines quality responsibilities by both parties
• Programmed Resolution of issues
• Time and responsibilities – (Keeping out politics)
• Minimizes redundant efforts
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements -What are They?
• Supplement to the contract– Define terms related to product quality– Determined by those directly involved with quality
…rather than commercial relationships
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements -What are They?
• Requirement of EU– Must be in place for QP (Qualified Person) to
release product
• Good idea in US– FDA reviewers perspective
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety Associates
When & How Do We Use Them?
• People of action vs. people of letters
• Contract administrators & lawyers do NOT usually handle quality issues
• Defines operation parameters
• Avoid citations by inspectors and double work
• Puts client in charge of their own product quality
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements -What are They?
• Problem handling tool
• Controls “helpful” meddlers (politics)
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety Associates
When & How Do We Use Them?
• Feeds into Quality release Map of Quality Release system on complex product manufacturing
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety Associates
Old salesman’s expression
• KISS Keep it simple …stupid
Quality Agreements Presentation _
Compliance Surety Associates
Lesson: An Unclear
Agreement Leads to an
Ugly Outcome!
Quality Agreements Presentation _
Compliance Surety Associates
When & How Do We Use Them?
However….
It seems each time a Quality Agreement is negotiated we still spend precious time covering the same generally agreed points
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements Presentation _
Compliance Surety Associates
Quality Agreements
Propose AAPS build a standardized or model Quality Agreement
2008 AAPS Annual Meeting and Exposition • Atlanta, GA
Quality Agreements Presentation _
Compliance Surety Associates
Ralph L. Dillon
Director
Compliance Surety Associates
PO Box 908
Mundelein, IL 60060 USA
Tel: 847-682-3924
E-mail: [email protected]
Quality Agreements Presentation _
Compliance Surety Associates
James P. McAndrew (Jim)
Vice President
PharmPro Services
2550 White Oak Circle
Aurora, IL 60502-9678 USA
Tel: 630-851-2550
E-mail: [email protected]
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