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    Basic CGMP Guidelines

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    Etta Jenee
    The document provides an overview of the US FDA's current Good Manufacturing Practices (cGMP) regulations for regulatory compliance in the pharmaceutical industry. It outlines requirements for organization and personnel, buildings and facilities, equipment, control of raw materials, production processes, warehousing, laboratories, and documentation. The key points are that cGMP regulations establish minimum standards for quality assurance, sanitation, facilities, equipment, control of components and drug products, validation, and record keeping.

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    Basic CGMP Guidelines

    Uploaded by

    Etta Jenee
    91 views23 pages
    The document provides an overview of the US FDA's current Good Manufacturing Practices (cGMP) regulations for regulatory compliance in the pharmaceutical industry. It outlines requirements for organization and personnel, buildings and facilities, equipment, control of raw materials, production processes, warehousing, laboratories, and documentation. The key points are that cGMP regulations establish minimum standards for quality assurance, sanitation, facilities, equipment, control of components and drug products, validation, and record keeping.

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    Basic CGMP Guidelines

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    The document provides an overview of the US FDA's current Good Manufacturing Practices (cGMP) regulations for regulatory compliance in the pharmaceutical industry. It outlines requirements for organization and personnel, buildings and facilities, equipment, control of raw materials, production processes, warehousing, laboratories, and documentation. The key points are that cGMP regulations establish minimum standards for quality assurance, sanitation, facilities, equipment, control of components and drug products, validation, and record keeping.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    91 views23 pages

    Basic CGMP Guidelines

    Uploaded by

    Etta Jenee
    The document provides an overview of the US FDA's current Good Manufacturing Practices (cGMP) regulations for regulatory compliance in the pharmaceutical industry. It outlines requirements for organization and personnel, buildings and facilities, equipment, control of raw materials, production processes, warehousing, laboratories, and documentation. The key points are that cGMP regulations establish minimum standards for quality assurance, sanitation, facilities, equipment, control of components and drug products, validation, and record keeping.

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    Basic cGMPs

    A Basic Overview of the US FDA’s


    Regulations for Regulatory Compliance

    Compliance Insight, Inc.


    Basic cGMPs
    • Remember, QUALITY
    is the responsibility of
    everyone
    • Don’t just make the
    product or do your job
    and leave it up to
    Quality Assurance fix
    the problems
    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
    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
    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
    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 the
    drug, then you will be
    excluded from direct contact
    with the product
    Buildings and Facilities
    • Building will be
    adequately sized for
    proper storage of
    equipment and
    material
    • Operations will be
    performed in specific
    areas
    Buildings and Facilities
    • Raw materials received will be
    placed in quarantine until tested
    • Rejected material will be
    separated
    • There will be adequate lighting
    • There will be adequate
    environmental controls
    • There will be air breaks on drains
    Buildings and Facilities
    • Sewage and trash will
    be stored and disposed
    of in a safe and
    sanitary manner
    • Adequate washing and
    toilet facilities will be
    available
    – hot and cold water
    – soap
    – single service towels
    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
    Buildings and Facilities
    • Buildings maintained
    pest and rodent free
    • Written procedures
    and approved
    rodentcides,
    insecticides and
    fungicides
    – will not affect product
    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
    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 lot
    number, name and status
    (released, quarantined, rejected)
    Control of Raw Materials
    • Sampling
    – shall be representative
    – maintain cleanliness
    – in approved area
    – prevent cross contamination
    – containers marked showing
    samples taken
    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
    Production and Process Control
    • Reconciliation to be
    done
    • Make sure areas are
    cleared of other lot
    information
    (packaging, labeling,
    etc.) prior to working
    with another lot
    • Double checks
    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)
    Laboratory
    • Will have specifications, standards,
    sampling plans, test procedures
    • Shall have a calibration and
    maintenance program
    – written with a time period for
    performance
    • Document all testing
    – use logbooks
    Laboratory
    • Tell supervisor if something goes
    wrong
    – don’t continue with testing if done
    improperly
    – 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
    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
    Documentation
    • Cross out with single line; initial
    and date
    • No white-out
    • Don’t use scrap paper
    • Change control on all documents
    • if changes are made, they have to be
    reviewed
    • Sign only what you performed or
    verified
    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”
    Questions?
    • Contact us at:
    – www.Compliance-Insight.com
    – 513-860-3512
    – [email protected]
    – Free consultation over the phone

    Copyrighted 2013 by Compliance Insight, Inc. 513-860-3512

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