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    PT706 ICH Guidelines

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    falgunipatra
    The document discusses guidelines from the International Conference on Harmonisation (ICH) for stability testing of pharmaceuticals. The ICH brings together regulatory authorities and the pharmaceutical industry from Europe, Japan and the US. The main guideline (ICH Q1A) describes stability testing requirements for drug registration. It divides the world into five climatic zones with different temperature and humidity requirements for long-term and accelerated stability studies. Several other ICH guidelines provide additional guidance on topics like photostability testing, new dosage forms, reduced testing designs, evaluation of stability data, and biotech products.

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    PT706 ICH Guidelines

    Uploaded by

    falgunipatra
    53 views2 pages
    The document discusses guidelines from the International Conference on Harmonisation (ICH) for stability testing of pharmaceuticals. The ICH brings together regulatory authorities and the pharmaceutical industry from Europe, Japan and the US. The main guideline (ICH Q1A) describes stability testing requirements for drug registration. It divides the world into five climatic zones with different temperature and humidity requirements for long-term and accelerated stability studies. Several other ICH guidelines provide additional guidance on topics like photostability testing, new dosage forms, reduced testing designs, evaluation of stability data, and biotech products.

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    ICH Guidelines Note

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    The document discusses guidelines from the International Conference on Harmonisation (ICH) for stability testing of pharmaceuticals. The ICH brings together regulatory authorities and the pharmaceutical industry from Europe, Japan and the US. The main guideline (ICH Q1A) describes stability testing requirements for drug registration. It divides the world into five climatic zones with different temperature and humidity requirements for long-term and accelerated stability studies. Several other ICH guidelines provide additional guidance on topics like photostability testing, new dosage forms, reduced testing designs, evaluation of stability data, and biotech products.

    Copyright:

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

    PT706 ICH Guidelines

    Uploaded by

    falgunipatra
    The document discusses guidelines from the International Conference on Harmonisation (ICH) for stability testing of pharmaceuticals. The ICH brings together regulatory authorities and the pharmaceutical industry from Europe, Japan and the US. The main guideline (ICH Q1A) describes stability testing requirements for drug registration. It divides the world into five climatic zones with different temperature and humidity requirements for long-term and accelerated stability studies. Several other ICH guidelines provide additional guidance on topics like photostability testing, new dosage forms, reduced testing designs, evaluation of stability data, and biotech products.

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    NSCBIP/PT706/Pharm. Tech.

    /Stability Testing/ICH Guidelies


    ICH Guidelines:
    The International Conference on Harmonisation (ICH) of Technical Requirements for Registration
    of Pharmaceuticals for Human Use - brings together the regulatory authorities and pharmaceutical
    industry of Europe, Japan and the US to discuss scientific and technical aspects and issue various
    guidelines to help with the drug regulaton.
    The Parent Guideline (ICH Q1A)
    This guidelinereleased in 1993describes the stability testing requirements for a registration
    application within the ICH region. It was explicitly intended to cover all that is required to get a
    marketing authorization granted in the ICH region.
    Climatic Zones
    The world has been divided into five climate zones with countries being assigned to the relevant
    zones. The five zones are described in figure.
    Climatic Climatic Condition
    Temperature
    Relative
    Example Countries
    Zones
    Humidity
    I

    Moderate

    21C

    45%

    Great Britain, Northern Europe,


    Canada, Russia

    II

    Subtropical

    25C

    60%

    USA, Japan, Southern Europe


    (mediterranean region)

    III

    Hot (dry)

    30C

    55%

    Iran, Iraq, Sudan

    IVa

    Tropical (Hot and


    Humid)

    30C

    65%

    Ghana, Nicaragua

    IVb

    Tropical (Hot and Very 30C


    Humid)

    65%

    Brazil, ASEAN Countries


    ( Indonesia, Malaysia,
    Singapore, Thailand etc.)

    Standard storage condition in accordance with ICH Q1A (R2)


    for climate zone I & II
    Long-term studies
    Intermediate conditions
    Accelerated studies
    for climate zones III & IV
    Long-term studies
    Accelerated studies

    Temperature Relative humidity

    Minimum time period

    25C 2
    30C 2
    40C 2

    60% 5%
    65% 5%
    75% 5%

    12 months
    6 months
    6 months

    30C 2
    40C 2

    65% 5%
    75% 5%

    12 months
    6 months

    Testing Frequency
    Long term studies
    First year every three months (0, 3, 6, 9, 12), second year every six months (12, 18, 24), third year
    and longer annually ( 24, 36, 48, 60)
    Accelerated studies
    General minimum three time points: 0,3,6 months, expectation of significant change increases
    testing by adding forth time point: 0, 1, 3, 6 months
    Intermediate storage condition studies
    Minimum four time points, including initial (0) and final submission (6 months)

    NSCBIP/PT706/Pharm. Tech./Stability Testing/ICH Guidelies


    Other ICH Stability Guidelines
    Photostability Testing (Q1B)
    Procedures and tools for testing the light sensitivity of a substance or product were not standardized
    or used in a common way prior to ICH. As a result, the ICH guideline for Photostability Testing of
    New Drug Substances and Products (Q1B) was finalized as an annex to the parent stability
    guideline. This ICH guideline helped to standardize approaches.
    Stability Testing for New Dosage Forms (Q1C)
    The ICH guideline for Stability Testing for New Dosage Forms (Q1C) was finalized to extend the
    main stability guideline for new formulations of already approved medicines and defines the
    circumstances under which reduced stability data can be accepted.
    Bracketing and Matrixing (Q1D)
    Guideline Q1D describes general principles for reduced stability testing and provides examples of
    bracketing and matrixing designs. The acceptance of this approach by regulators is saving
    manufacturers a huge amount of unnecessary stability testing.
    Evaluation of Stability Data (Q1E)
    This document extends the main guideline by explaining possible situations where extrapolation of
    retest periods/shelf-lives beyond the real-time data may be appropriate. Furthermore, it provides
    examples of statistical approaches to stability data analysis.
    Stability Testing of Biotech Products (Q5C)
    Because most of the typical proteins and polypeptides are less stable than small molecules, and
    because test procedures for assay and degradation products are quite unique, very early in the
    discussion the ICH Steering Committee agreed to let the biotech experts develop a guideline for
    these types of products separate from Q1A.

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