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    Presentation Quality Risk Management Issues

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    Mohammed Imran
    The document summarizes key issues identified with quality risk management practices at pharmaceutical companies inspected by the Therapeutic Goods Administration. Some of the main issues included a lack of integration of quality risk management policies and procedures into pharmaceutical quality systems, incomplete identification and assessment of risks, inappropriate application of risk mitigation strategies, and poor definition of critical quality attributes and critical process parameters which hindered effective risk assessment. The TGA expects demonstrated implementation of quality risk management principles within quality systems, consistent use of risk management tools, and clear documentation of how risks are assessed, managed, and communicated.

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    Presentation Quality Risk Management Issues

    Uploaded by

    Mohammed Imran
    32 views17 pages
    The document summarizes key issues identified with quality risk management practices at pharmaceutical companies inspected by the Therapeutic Goods Administration. Some of the main issues included a lack of integration of quality risk management policies and procedures into pharmaceutical quality systems, incomplete identification and assessment of risks, inappropriate application of risk mitigation strategies, and poor definition of critical quality attributes and critical process parameters which hindered effective risk assessment. The TGA expects demonstrated implementation of quality risk management principles within quality systems, consistent use of risk management tools, and clear documentation of how risks are assessed, managed, and communicated.

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    The document summarizes key issues identified with quality risk management practices at pharmaceutical companies inspected by the Therapeutic Goods Administration. Some of the main issues included a lack of integration of quality risk management policies and procedures into pharmaceutical quality systems, incomplete identification and assessment of risks, inappropriate application of risk mitigation strategies, and poor definition of critical quality attributes and critical process parameters which hindered effective risk assessment. The TGA expects demonstrated implementation of quality risk management principles within quality systems, consistent use of risk management tools, and clear documentation of how risks are assessed, managed, and communicated.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    32 views17 pages

    Presentation Quality Risk Management Issues

    Uploaded by

    Mohammed Imran
    The document summarizes key issues identified with quality risk management practices at pharmaceutical companies inspected by the Therapeutic Goods Administration. Some of the main issues included a lack of integration of quality risk management policies and procedures into pharmaceutical quality systems, incomplete identification and assessment of risks, inappropriate application of risk mitigation strategies, and poor definition of critical quality attributes and critical process parameters which hindered effective risk assessment. The TGA expects demonstrated implementation of quality risk management principles within quality systems, consistent use of risk management tools, and clear documentation of how risks are assessed, managed, and communicated.

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    Quality Risk Management Issues

    Neale Baldwin
    Senior GMP Inspector
    Manufacturing Quality Branch

    TGA Quality Risk Management – ARCS 2018


    Overview
    1. QRM Inspection Examples
    2. Key Issues Identified
    3. TGA Expectations
    4. Improvement opportunities
    - Process/Product Definition
    - CQA/CPP
    5. Risk management

    TGA Quality Risk Management – ARCS 2018


    1
    Issues identified at inspection
    • In a number of examples of Change Controls reviewed, not all risks were identified, assessed or appropriate
    risk mitigation strategies implemented to ensure that the product would meet all critical quality attributes.

    • Although the company had a current Quality Risk Management procedure in place, it was not clear how this
    was adopted in relevant parts of the Quality Management system, for example,
    – The change control risk assessment process was not based on the methods identified in the QRM SOP.
    – The impact assessment process defined in the Deviation management process was not aligned with the
    QRM processes identified in the company’s QRM procedure.
    – It was not clear where the QRM processes described in the QRM SOP were used as there was no
    examples provided to demonstrate its application.

    • The risks of cross contamination was not fully addressed to ensure that residues would not contaminate
    subsequent batches other than from direct, product-contact equipment (i.e.. Did not consider cross-
    contamination from the area where multiple products were manufactured)
    TGA Quality Risk Management – ARCS 2018 2
    Issues identified at inspection
    • For an API manufacturer, the company had assessed all product implicating risks
    as low as the likelihood of detection was high due to further processing steps (not
    within their control) was expected to detect any non-compliant product.

    • There was no training associated with the application of Quality Risk


    Management processes and subsequently, risk assessments reviewed were
    either incomplete or inconsistently utilised

    • The company had a risk register, however, there was limited examples recorded
    despite a number of completed risk assessments observed in multiple PQS
    processes.
    TGA Quality Risk Management – ARCS 2018 3
    Summary of Issues identified

    Lack of integration of the QRM Policy/Procedure into the


    PQS
    It is all good and well to have a well defined QRM Procedure, but if it is not clear how it is used or
    integrated in the PQS and it is not able to be explained at inspection then it would be reasonable
    to expect that it is not being used appropriately!

    Particularly for OOS/OOT, Deviation, Change Control, Customer Complaints

    TGA Quality Risk Management – ARCS 2018 4


    Issues identified at inspection
    • Poor definition of when to apply risk management
    processes
    • Poor training with respect to use of risk management
    processes
    • Incomplete identification, assessment and control of risk
    • Inappropriate application of risk mitigation strategies
    • Inappropriate acceptance of risk
    • Incongruent application of risk management tools
    • Lack of awareness of risk processes and their outcomes
    • Poor assessment of effectiveness of risk mitigation
    strategies employed
    • Complicated Risk Assessment processes that appear to
    be incorrectly applied and often not actioned

    TGA Quality Risk Management – ARCS 2018 5


    Lack of clear integration of Quality Risk Management Principles
    within relevant Pharmaceutical Quality System Processes

    Lack of oversight/escalation of Quality Risks and there


    appropriate, timely mitigation

    TGA Quality Risk Management – ARCS 2018 6


    ICH Q9
    Quality Risk Management (QRM) is a systematic process for
    the
    assessment, control, communication & review of risks to
    quality of the drug product across the product lifecycle

    – The evaluation of the risk to quality should be based on


    scientific knowledge & ultimately link to the protection of
    the patient

    – The level of effort, formality & documentation of the


    quality risk management process should be
    commensurate with the level of risk
    TGA Quality Risk Management – ARCS 2018 7
    TGA expectations
    Written Policy (or Procedure)
     Identify that company’s approach to QRM
     Where in the PQS are these principles applied
     What methods are to be used (i.e. formal or informal)
     How Risk Assessments and their outcomes are documented & managed
     How these are communicated
     How mitigation strategies are applied
     How the effectiveness of mitigation strategies are assessed

    TGA Quality Risk Management – ARCS 2018 8


    TGA expectations cont.
    Demonstrated implementation of QRM into PQS
    – Linkage/consistency of PQS procedures where QRM is described to the QRM SOP/Policy
    – Prospective risk assessment versus Impact assessment (and where/when used)
    – Formal methods defined and where/when these are used
    – Where and when informal processes are applicable (and how these should be recorded)
    – Training of staff in QRM approach including formal processes
    – Risk register (if/where applicable)
    – Consistent use of QRM available in relevant PQS records
    – Use in prospective activities (i.e. Change Control, Validation, etc.)
    – Use in retrospective activities (i.e. OOS, Deviation, Customer Complaints)
    TGA Quality Risk Management – ARCS 2018 9
    For validated manufacturing processes

    How can risk be assessed if the manufacturing


    process is not defined and critical aspects are
    identified?

    TGA Quality Risk Management – ARCS 2018 10


    Product/Process Definition
    Critical Quality Attributes (CQA)
    A physical, chemical, biological, or microbiological property or characteristic that
    should be within an appropriate limit, range, or distribution to ensure the desired
    product quality (ICH Q8)

    Critical Process Parameter (CPP)


    A process parameter whose variability has an impact on a CQA and therefore
    should be monitored or controlled to ensure the process produces the desired
    quality. (ICH Q8)

    TGA Quality Risk Management – ARCS 2018 11


    ANNEX 15
    QUALIFICATION AND VALIDATION
    Principle - It is a GMP requirement that manufacturers control the critical aspects of
    their particular operations through qualification and validation over the life cycle of
    the product and process.

    Clause 5.7 - Process validation should establish whether all quality attributes and
    process parameters, which are considered important for ensuring the validated
    state and acceptable product quality, can be consistently met by the process. The
    basis by which process parameters and quality attributes were identified as being
    critical or non-critical should be clearly documented, taking into account the results
    of any risk assessment activities.
    TGA Quality Risk Management – ARCS 2018 12
    Process/Product Definition
    Product Design/Development should aim to provide:
    – Definition of Finished Dosage Form Specifications (or API)
    – Key Manufacturing/Process stages
    – Key in process Critical Quality Attributes
    – Key in-process Critical Process Parameters
    – Key Raw/Starting Material Parameters
    Process/Product Understanding identifies critical/non-critical
    activities for QRM
    TGA Quality Risk Management – ARCS 2018 13
    Risk Interpretation
    Identified critical/non-critical activities assists in RA:
    - Process/Product changes/Issues
    - Equipment changes/issues
    - Facility changes/issues
    - Raw/starting material changes/issues
    - Testing changes/issues
    - Validation

    TGA Quality Risk Management – ARCS 2018 14


    Summary

    TGA Quality Risk Management – ARCS 2018 15

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