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    Module 4 - Risk Assessment

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    anita shinde
    The document discusses risk assessment of HVAC systems in pharmaceutical facilities. It notes that HVAC systems are integral to facility functionality and should be qualified using a risk-based approach. This involves assessing risks, controlling risks, reviewing risks, and communicating about risks. Failure mode and effects analysis was used to assess risks to the HVAC system and determine the appropriate scope and extent of qualification and validation. The various parameters to be evaluated and validated for the HVAC system are listed. Risk assessment is presented as an essential tool for HVAC system qualification to ensure risks are identified and critical risks are controlled.

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    Module 4 - Risk Assessment

    Uploaded by

    anita shinde
    281 views2 pages
    The document discusses risk assessment of HVAC systems in pharmaceutical facilities. It notes that HVAC systems are integral to facility functionality and should be qualified using a risk-based approach. This involves assessing risks, controlling risks, reviewing risks, and communicating about risks. Failure mode and effects analysis was used to assess risks to the HVAC system and determine the appropriate scope and extent of qualification and validation. The various parameters to be evaluated and validated for the HVAC system are listed. Risk assessment is presented as an essential tool for HVAC system qualification to ensure risks are identified and critical risks are controlled.

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    Module 4 - Risk assessment

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    The document discusses risk assessment of HVAC systems in pharmaceutical facilities. It notes that HVAC systems are integral to facility functionality and should be qualified using a risk-based approach. This involves assessing risks, controlling risks, reviewing risks, and communicating about risks. Failure mode and effects analysis was used to assess risks to the HVAC system and determine the appropriate scope and extent of qualification and validation. The various parameters to be evaluated and validated for the HVAC system are listed. Risk assessment is presented as an essential tool for HVAC system qualification to ensure risks are identified and critical risks are controlled.

    Copyright:

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

    Module 4 - Risk Assessment

    Uploaded by

    anita shinde
    The document discusses risk assessment of HVAC systems in pharmaceutical facilities. It notes that HVAC systems are integral to facility functionality and should be qualified using a risk-based approach. This involves assessing risks, controlling risks, reviewing risks, and communicating about risks. Failure mode and effects analysis was used to assess risks to the HVAC system and determine the appropriate scope and extent of qualification and validation. The various parameters to be evaluated and validated for the HVAC system are listed. Risk assessment is presented as an essential tool for HVAC system qualification to ensure risks are identified and critical risks are controlled.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    Module 4 – Risk Assessment

    Heating, ventilation, and air system encompasses heating, ventilation, and air
    conditioning, which is integral component of pharmaceutical facility
    functionality.
    The qualification of HVAC systems is done by using a risk based approach.
    The risk management program consists of four major components:
    1) Risk assessment,
    2) Risk control,
    3) Risk review, and
    4) Risk communication.
    All four components are essential. All the above methods should address the
    mentioned four basic components.
    Failure mode effect analysis (FMEA) concepts were used for risk assessment of a
    HVAC system to determine the scope and extent of qualification and validation in
    the work.
    The HVAC is the “direct impact” system in the aseptic practice which directly
    affects the product quality and regulatory compliance.
    The level of risk associated with the HVAC system was assessed based on the
    impact and severity of the probable risk in aseptic practice in sterile
    manufacturing.
    After completion of the risk assessment the recommended actions were extended
    and verified against the qualification stages of the HVAC system.
    The various parameters to be evaluated for the validation of HVAC system include
    air flow pattern, air flow velocity, air changes per hour, filter leak test, particle
    count, viable monitoring, filter integrity test, pressure difference, recovery test for
    temperature and humidity, temperature and humidity uniformity, and fresh air
    determination.
    Validation of HVAC system involves systemized and assembled documents of
    1) Functional specifications
    2) Design drawings
    3) Plans and specifications
    4) Validation master plan
    5) Testing, adjusting, and balancing (TAB) and
    6) Startup reports.
    Risk assessment (FMEA model)
    Evaluate the overall risk of the qualification and validation steps by combining
    individual risk values.
    For the most of the direct impact system, the severity will always be high. The
    risk priority ranking (RPR) then becomes a combination of an occurrence and
    detection.
    If the level of risk is not acceptable, a recommendation must be made to
    modify the qualification and validation steps to reduce the risk to an
    acceptable level or enhance the method of detection to reduce the risk to an
    acceptable level.
    Preference should be given to reducing the occurrence rather than increasing
    the level of detection.
    After completion of the risk assessment, the recommended action of
    unacceptable risk extended to qualification stages of HVAC system to have a
    high level of assurance and if the test result are not acceptable, carry out
    corrective action that may include modification in the existing controls and the
    system.
    Qualification and validation is appearing to be the beginning of a continuous
    development process in pharmaceutical QA.
    Risk assessment is an essential tool for qualification of HVAC system in aseptic
    processes.
    It is not just a tool for cGMP compliance, its offers real benefits to the
    validation process by identifying risks and ensuring that critical risks are
    controlled.
    By focusing on managing risks to the patient, pharmaceutical manufacturers
    can ensure that the right resources are applied at the right place and at the
    right time improving patient safety while eliminating unnecessary qualification
    and validation efforts.

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