basic gmps

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    Basic cGMPs

    A Basic Overview of the US FDAs

    Regulations for Regulatory

    Compliance

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    Basic cGMPs

    Remember, QUALITY

    is the responsibility of

    everyone Dont just make the

    product or do your job

    and leave it up to

    Quality Assurance fixthe problems

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    The Regulations

    cGMP stands for current

    Good Manufacturing

    Practices Always improving and

    changing (that is why they

    are called current)

    Regulations are a

    minimum that must be met

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    The Regulations

    cGMPs are listed in

    the CFR (Code of

    Federal Regulations)Part 210 and 211

    Part 210 - definitions

    Part 211 - basic

    instructions

    Part 11 - electronic

    data

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    Organization and Personnel

    Shall have a Quality Unit

    with responsibility to reject

    or approve all material,procedures and

    specifications

    Everyone will have

    sufficient training,knowledge and experience

    to do their job

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    Organization and Personnel

    Wear clean clothing

    Wear protective apparel to

    prevent contamination Practice good sanitation

    If you are sick or have open

    lesions that would impact thedrug, then you will be

    excluded from direct contact

    with the product

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    Buildings and Facilities

    Building will be

    adequately sized for

    proper storage ofequipment and

    material

    Operations will be

    performed in specificareas

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    Buildings and Facilities

    Raw materials received will be

    placed in quarantine until tested

    Rejected material will beseparated

    There will be adequate lighting

    There will be adequateenvironmental controls

    There will be air breaks on drains

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    Buildings and Facilities

    Sewage and trash will

    be stored and disposed

    of in a safe andsanitary manner

    Adequate washing and

    toilet facilities will be

    available hot and cold water

    soap

    single service towels

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    Buildings and Facilities

    Building will be

    maintained in a clean

    and sanitary manner There will be cleaning

    schedules with

    approved cleaning

    agents SOPs on cleaning

    Buildings in a good

    state of repair

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    Buildings and Facilities

    Buildings maintained

    pest and rodent free

    Written proceduresand approved

    rodentcides,

    insecticides and

    fungicides will not affect product

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    Equipment

    Will be maintained in a

    good state of repair

    written schedule of

    maintenance

    will be cleaned

    written schedule of

    cleaning

    clean after each batch

    approved cleaning agents

    will not affect product

    ID number on equipment

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    Control of Raw Materials

    Received in Quarantine

    not used until released

    Written procedures on receipt,handling and sampling

    Stored off the floor

    Each container marked with lotnumber, name and status

    (released, quarantined, rejected)

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    Control of Raw Materials

    Sampling

    shall be representative

    maintain cleanliness in approved area

    prevent cross contamination

    containers marked showing

    samples taken

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    Production and Process Control

    There will be written procedures

    Document activities

    batch record log books

    Control contamination

    Cleanliness tanks, paddles, piping, probes, etc.

    Keep organized

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    Production and Process Control

    Reconciliation to be

    done

    Make sure areas arecleared of other lot

    information

    (packaging, labeling,

    etc.) prior to workingwith another lot

    Double checks

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    Warehouse

    It shall be clean

    Sections clearly identified

    (quarantine, released,rejected)

    quarantine - yellow

    released - green

    rejected - red

    First In - First Out

    Track inventory and sold lots

    (quantities to where)

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    Laboratory

    Will have specifications, standards,

    sampling plans, test procedures

    Shall have a calibration andmaintenance program

    written with a time period for

    performance

    Document all testing

    use logbooks

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    Laboratory

    Tell supervisor if something goes

    wrong

    dont continue with testing if doneimproperly

    check results prior to discarding sample

    have second person check

    check acceptance values Stability testing will be done

    Reserve samples will be kept for final

    products over the period of the

    expiration date

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    Documentation

    Records will be maintained batch records

    testing

    investigations

    training

    maintenance

    cleaning

    almost everything

    If it was not documented, then it did

    not happen!

    Written in ink

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    Documentation

    Cross out with single line; initial

    and date

    No white-out Dont use scrap paper

    Change control on all documents if changes are made, they have to be

    reviewed

    Sign only what you performed or

    verified

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    Documentation

    Write down correct date

    do not write down previous date (back

    dating) If you forgot to sign something on a

    previous date, correct the problem by

    writing:

    Performed on May 10, 2012; written on

    May 12, 2012