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    Best Practices For Creating Quality Agreements

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    Michele Volpe
    The document provides guidance on quality agreements which are legal documents that define responsibilities between a company and its manufacturing contractors. It discusses what should be included such as defining responsibilities, communication protocols, sampling and testing requirements, and procedures for deviations, audits, and annual reviews.

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    © All Rights Reserved
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    Best Practices For Creating Quality Agreements

    Uploaded by

    Michele Volpe
    36 views33 pages
    The document provides guidance on quality agreements which are legal documents that define responsibilities between a company and its manufacturing contractors. It discusses what should be included such as defining responsibilities, communication protocols, sampling and testing requirements, and procedures for deviations, audits, and annual reviews.

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    Best Practices for Creating Quality Agreements

    Original Title

    Best Practices for Creating Quality Agreements

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    The document provides guidance on quality agreements which are legal documents that define responsibilities between a company and its manufacturing contractors. It discusses what should be included such as defining responsibilities, communication protocols, sampling and testing requirements, and procedures for deviations, audits, and annual reviews.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    36 views33 pages

    Best Practices For Creating Quality Agreements

    Uploaded by

    Michele Volpe
    The document provides guidance on quality agreements which are legal documents that define responsibilities between a company and its manufacturing contractors. It discusses what should be included such as defining responsibilities, communication protocols, sampling and testing requirements, and procedures for deviations, audits, and annual reviews.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 33

    QUALITY AGREEMENTS

    John J. Vajda
    BFC Consultants
    ©2009
    SCENARIO
    Contract signed for manufacturing
    Everyone happy
    What do we do next?
    HISTORY
    First appeared in UK MCA in 1991 called a
    Technical Agreement
    Currently it is the “MCA Rules and
    Guidance for Pharmaceutical Manufacturers
    and Distributors, 2002”
    Also known as the Orange Book
    HISTORY…
    FDA “Guidance for Industry: Cooperative
    Manufacturing Arrangements for Licensed
    Biologics” August 1999 best US reference
    Gives some examples of differences
    between Quality Agreements and business
    agreements
    PURPOSE
    To define in detail the functional aspects of
    the relationship
    Establish responsibilities for Quality and
    Production personnel for each party
    YOU MUST
    Assure the Contractor is qualified
    Audit GMP compliance
    Provide ALL information required
    Explain hazards
    CONTRACTOR MUST
    Have adequate resources
    Approved raw material sources
    Assure quality
    Not ”farm out”
    FDA GUIDANCE SUGGESTS
    Identification and location of contractor
    Defined responsibilities of each party
    Description of materials provided for the
    Contractor and details of shipment
    Operations to be performed by the
    Contractor
    Mutually agreed documentation package
    FDA GUIDANCE
    SUGGESTS…
    Contractor must agree to:
     Provide notification of any changes
     To facility
     To manufacturing process
     To material sources
     To other products being made
     Provide notification of deviations
    Agreement on audits
    HOW TO STRUCTURE A QUALITY AGREEMENT

    Legal document, needs legal review


    STAND-ALONE OR?
    Con Pro
     Legal objections  Can be updated
     If product is biologic and sold  Readily available
    in Europe  Available for inspections
    WHAT’S THE CONTRACT?
    Written document
    Technically sound
    Defined responsibilities
    Access to
     Records
     Premises
     Samples
    WHAT’S THE CONTRACT?…
    Allow visits
    Define release criteria
     Must meet marketing needs
    Sampling locations
    KEY CONTENTS

    This is NOT a comprehensive list.


    Other points may be added depending on
    specific needs and corporate cultures.
    WHAT DOES NOT BELONG
    Business terms and conditions
    Pricing
    Forecasts and delivery terms
    Confidentiality agreement
    Liability and dispute resolution issues
    These belong in a separate Business
    Agreement!
    DISPUTE RESOLUTIONS
    Refer to in Quality Agreement but keep
    details in Business Agreement
    Potential issues
     Testing
     Release
     Documentation
    RESPONSIBILITIES
    Need to be clearly defined without any
    ambiguity!
    If in doubt as to what to include follow 21
    CFR 211 and assign which company is
    doing which section
    COMMUNICATION
    Will eliminate:
     “ I thought …”
     “ Not sure”
     “ Don’t know”
     “ Did not think it was important”
    Assignment of personnel by both parties
    including contact information
    COMMUNICATION…
    Timeliness
    Communicating Quality issues
     We want it NOW! (YOU)
     We want to investigate first (contractor)
    DOCUMENTATION
    Who is writing what?
    Who is approving what?
    What governs if multiple documents apply
    Summaries vs. full reports
    Retention and ownership
    BATCH IDENTIFICATION
    Parties will have different systems
    How will product be identified
    Explain all codes to eliminate
    misunderstandings
    DEVIATIONS
    How to classify? minor vs., catastrophic
    Responsibility for reporting, trending and
    resolution
    Time is of the essence!
    Who can approve what?
    DEVIATIONS…
    Define expectations for communications
    Provide examples of major deviations
    AUDITS
    Visit vs. audit vs. inspection
    On- site rep vs. periodic
    Frequency
    Any costs or limitations?
    What to do if FDA comes
     Will you participate. How?
    SAMPLING AND TESTING
    Batch records
    What is acceptable?
     Purity, stability, expiration
    What method?
    Who is testing what?
    Third party labs
     Qualifications
    SAMPLING AND TESTING…
    Who is approving what?
     Retention
     Shelf life
    International requirements
    SUBCONTRACTING
    Is it allowed?
    If so, how is it approved?
     Right to audit
    PROBLEMS
    Complaints
     How they are:
     Received
     Communicated
     Investigated
     Reported
    Recalls
    ANNUAL REVIEW
    What to include?
    Format
     Template
    Timing
    AGREEMENT APPROVAL
    QA for both parties
    Operations
    Legal
    Others
     Marketing
     BD
    REFERENCES
    “UK MCA Rules and Guidance for
    Pharmaceutical Manufacturers and
    Distributors 2002”
    FDA “Guidance for Industry, Cooperative
    Manufacturing Agreements for Licensed
    Biologics”
    FDA 21CFR211
    CONTACT INFORMATION
    BFC Consultants
    John J. Vajda
    Phone: 408-640-9158
    E-mail: [email protected]
    Web: www.bfcconsultants.com
    QUESTIONS

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