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  • ISO Vs GMP

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    alchemist25000
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    ISO stands for the International Organization for Standardization, which publishes voluntary specifications that organizations can choose to comply with but are not legally required to obtain certification. GMP stands for Good Manufacturing Practices, which are mandatory regulations enforced by authorities like the FDA and EMA. GMP is a more specific standard designed for organizations that manufacture products requiring high safety and quality levels, such as pharmaceuticals, while ISO can be applied more generally to any type of organization.

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    ISO vs GMP

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    ISO stands for the International Organization for Standardization, which publishes voluntary specifications that organizations can choose to comply with but are not legally required to obtain certification. GMP stands for Good Manufacturing Practices, which are mandatory regulations enforced by authorities like the FDA and EMA. GMP is a more specific standard designed for organizations that manufacture products requiring high safety and quality levels, such as pharmaceuticals, while ISO can be applied more generally to any type of organization.

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    © All Rights Reserved
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    2 views4 pages

    ISO Vs GMP

    Uploaded by

    alchemist25000
    ISO stands for the International Organization for Standardization, which publishes voluntary specifications that organizations can choose to comply with but are not legally required to obtain certification. GMP stands for Good Manufacturing Practices, which are mandatory regulations enforced by authorities like the FDA and EMA. GMP is a more specific standard designed for organizations that manufacture products requiring high safety and quality levels, such as pharmaceuticals, while ISO can be applied more generally to any type of organization.

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    of 4

    I

    SO
    VS

    GMP

    MohamedRaed
    I
    SO
    s
    t andsfor
    “
    Internat
    ional
    Organi
    zat
    ionf
    orSt
    andar
    diz
    ati
    on”
    AlI
    lSOs peci
    fi
    cati
    onshazverequi
    rement s
    whicharevolunt
    ary:
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    i
    gati
    ont oobt
    ai nc
    er t
    if
    ic
    ati
    on,
    thi
    sstandardispubl
    is
    hedbyt he(ISO),
    anindependentnon-governmentalorgani
    zati
    on.

    I
    SOisamoregener
    als
    tandard
    t
    hatcanbeappl
    i
    edtoanytypeofor
    gani
    zat
    ion.

    MohamedRaed
    GMP
    s
    tandsf
    or
    “
    GoodManuf
    act
    uri
    ngPr
    act
    ices
    ”
    GMPhaz v
    er equirement s
    whichar emandat ory:
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    ti
    es
    l
    iketheFDAandEMA, whichhaves peci
    fi
    cregul
    ati
    ons
    thatmanuf acturersmus tcomplywi t
    h
    toens urepr oductsafetyandquality,
    andf ail
    uret odos oc anlead
    torefus alorwithdrawalofmanuf ac t
    uri
    ngauthor
    iz
    ati
    on.

    GMPi samor especif


    icstandard
    thati
    sdes i
    gnedfororganiz
    ationsthat
    manuf ac
    tureproduct
    st hatrequir
    e
    ahighlevel
    ofsafetyandqual i
    ty.

    MohamedRaed
    I
    nGener
    al,
    Speci
    al
    lyISO9001isagoodstart
    ingpoi
    nt
    f
    oranyorgani
    zat
    ionthatwantst
    oi mpr
    ove
    i
    tsqual
    it
    ymanagements yst
    em.

    MohamedRaed

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