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    Dietary Supplement Documentation Self-Assessment

    Uploaded by

    J.w. Morgan
    A self assessment or gap analysis of 21 CFR 111 documents for small nutritional supplement manufacturers

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Dietary Supplement Documentation Self-Assessment

    Uploaded by

    J.w. Morgan
    120 views2 pages
    A self assessment or gap analysis of 21 CFR 111 documents for small nutritional supplement manufacturers

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

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    A self assessment or gap analysis of 21 CFR 111 documents for small nutritional supplement manufacturers

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    120 views2 pages

    Dietary Supplement Documentation Self-Assessment

    Uploaded by

    J.w. Morgan
    A self assessment or gap analysis of 21 CFR 111 documents for small nutritional supplement manufacturers

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    DIETARY SUPPLEMENT DOCUMENTATION SELF-ASSESSMENT

    CLIENT _______________________________

    DATE ________________

    SOPs

    Criticality *

    Equipment

    YES

    NO

    Calibration SOPs for Mfg Equipment (and Logs)

    Equipment

    YES

    NO

    Validation of Equipment and Processes

    Equipment

    YES

    NO

    Utilities (Water, Air)


    Distribution
    Product Disposition (and Logs)
    Sampling and Handling for Lab Testing (and Logs)
    Bioburden Sampling and Handling (and Logs)

    Facilities
    Holding & Distribution
    Holding & Distribution
    Laboratory Controls
    Laboratory Controls

    YES

    NO

    YES

    NO

    YES

    NO

    Stability Program

    Laboratory Controls
    Packaging and Labeling Control

    YES

    NO

    YES

    NO

    SOP

    Type/Section

    Equipment Cleaning (and Logs)

    Labels and Promotional Materials - Control &


    Approvals (and Docs)
    Packaging Development and Approvals (and Forms)

    Present

    Packaging and Labeling Control

    Manufacturing Methods (and Batch Records)

    Production and Process Controls

    YES

    NO

    Acceptance

    Production and Process Controls

    YES

    NO

    Nonconforming Product

    Production and Process Controls

    YES

    NO

    Facility Cleaning Procedures (and Logs)

    Production and Process Controls

    YES

    NO

    Environmental Monitoring (and Logs)

    Production and Process Controls

    YES

    NO

    Specifications Development

    Production and Process Controls

    YES

    NO

    Audits & Inspections (and Form)


    Management Responsibilities (and Minutes
    Template)

    Stand-alone
    Stand-alone

    YES

    NO

    YES

    NO

    Personnel Training and Sanitation (and Logs)

    Stand-alone

    YES

    NO

    Complaint Management (and Spreadsheet)

    Stand-alone

    YES

    NO

    DIETARY SUPPLEMENT DOCUMENTATION SELF-ASSESSMENT

    CLIENT _______________________________

    DATE ________________

    SOP

    Type/Section

    SOPs

    Criticality *

    Corrective and Preventive Action (and Spreadsheet)

    Stand-alone

    YES

    NO

    Corrections and Removals (Recalls)

    Stand-alone

    YES

    NO

    Computer Related Systems

    Stand-alone

    YES

    NO

    HACCP Procedure (and Forms)


    Quality Agreements (and Template)
    Supplier Management
    Contractor Management

    Stand-alone
    Supplier
    Supplier
    Supplier

    YES

    NO

    YES

    NO

    Quality manual

    Tier 1

    YES

    NO

    24
    *Criticality
    A = Highest Prioirity - needed prior to production initiation
    B = Moderate Priority - needed before first batch delivered
    C = Lower Priority - May be developed within 60 days of production initiation

    Present

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