aaps quality agreement presentation share

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 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 -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



Do I Need a QualityAgreement with my Service

Provider?



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



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.



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.



Five Benefits of a Quality Agreement

Accountability

Risk Management

Communications

Coordination & Planning

Compliance



Clearly Establish Responsibilities between parties

Determine damage resolutions before they’re needed

Quality Agreement Benefits Accountability



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 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 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 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.



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




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.




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.




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.



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.




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.




Release

•Establishes which Quality Unit will be responsible forfinal release and any in-process release required.




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.




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)




Safety

•Requires an occupational safety program tobe maintained by contractors.

•Sets out occupational/environmental risks (if any) and required steps to mitigate those risks.




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.




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.




Returns

•Determines who handles product returns.

•Determines what information will be shared between parties in regard to retuned product.



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.



Features of Effective Quality Agreements

Multilateral

Clear

Simple

Comprehensive



Features of Effective Quality Agreements - Simplicity

Plain English – not Lawyer Speak

Use terms common to all parties

Don’t be verbose or tedious



Features of Effective Quality Agreements - Clarity

Organized, Easy to Grasp Format

•Checklist by Activity Category

•Activities by Department

•Timeline of Activity



Features of Effective Quality Agreements - Multilateral

Every Player should Participate

The process should be transparent to Non-decision makers



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!



Features of Effective Quality Agreements - Comprehensive

Eventualities / Responsibilities

Valu

eNumber of Likely EventualitiesFaced by your project

Agreement Value Maximized



Visibility throughout the Organization

The most important Feature of a Successful Quality Agreement


Compliance Surety AssociatesQuality Agreements Presentation _


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 -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

#1 Document to coordinate quality of product



Product Surety Initiative

WHOAnti-Counterfeiting Forum

Cambridge University




• 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

Compliance Surety Associate

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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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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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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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Quality Agreements





Quality Agreements


At a minimum ADD …….Call Lists

--- Include mobile phones & home numbers

--- List alternate contacts

--- Clearly define roles &/or responsibilities




Quality Agreements


At a minimum ADD…….Call Lists

For complex supply chains – ADD Quality Release Maps




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)



What is

“bad” or “good” and who

defines it?





them ?


– 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




them ?


– 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 -What are They?

• Supplement to the contract– Define terms related to product quality– Determined by those directly involved with quality

…rather than commercial relationships






• Requirement of EU– Must be in place for QP (Qualified Person) to

release product

• Good idea in US– FDA reviewers perspective





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






• Problem handling tool

• Controls “helpful” meddlers (politics)






• Feeds into Quality release Map of Quality Release system on complex product manufacturing





Old salesman’s expression

• KISS Keep it simple …stupid



Lesson: An Unclear

Agreement Leads to an

Ugly Outcome!




However….

It seems each time a Quality Agreement is negotiated we still spend precious time covering the same generally agreed points





Quality Agreements

Propose AAPS build a standardized or model Quality Agreement

2008 AAPS Annual Meeting and Exposition • Atlanta, GA



Ralph L. Dillon

Director


PO Box 908

Mundelein, IL 60060 USA

Tel: 847-682-3924

E-mail: [email protected]



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]

aaps quality agreement presentation share

Documents

quality agreement cover

quality units

contractors quality

sponsors quality unit

project team

regulatory actions

annualproduct review

submittable data sets