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    CAPA Change Management

    Uploaded by

    MuhammadAmdadulHoque
    This document outlines procedures for change management and corrective and preventive action (CAPA) at Renata Limited. It discusses: - The change management procedure which establishes a standard process to address changes to products, processes, equipment and more. It details roles and responsibilities, applicability, and the steps for change identification, assessment, approval and implementation. - The CAPA procedure which describes the process for correcting and preventing events that could adversely affect quality. It defines different action types and outlines how CAPA may be initiated based on deviations, investigations, audits and more. - Both procedures reference SOPs that provide more detailed guidance and are applicable company-wide to maintain quality and compliance with

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    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd

    CAPA Change Management

    Uploaded by

    MuhammadAmdadulHoque
    105 views22 pages
    This document outlines procedures for change management and corrective and preventive action (CAPA) at Renata Limited. It discusses: - The change management procedure which establishes a standard process to address changes to products, processes, equipment and more. It details roles and responsibilities, applicability, and the steps for change identification, assessment, approval and implementation. - The CAPA procedure which describes the process for correcting and preventing events that could adversely affect quality. It defines different action types and outlines how CAPA may be initiated based on deviations, investigations, audits and more. - Both procedures reference SOPs that provide more detailed guidance and are applicable company-wide to maintain quality and compliance with

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    © © All Rights Reserved

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    This document outlines procedures for change management and corrective and preventive action (CAPA) at Renata Limited. It discusses: - The change management procedure which establishes a standard process to address changes to products, processes, equipment and more. It details roles and responsibilities, applicability, and the steps for change identification, assessment, approval and implementation. - The CAPA procedure which describes the process for correcting and preventing events that could adversely affect quality. It defines different action types and outlines how CAPA may be initiated based on deviations, investigations, audits and more. - Both procedures reference SOPs that provide more detailed guidance and are applicable company-wide to maintain quality and compliance with

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    105 views22 pages

    CAPA Change Management

    Uploaded by

    MuhammadAmdadulHoque
    This document outlines procedures for change management and corrective and preventive action (CAPA) at Renata Limited. It discusses: - The change management procedure which establishes a standard process to address changes to products, processes, equipment and more. It details roles and responsibilities, applicability, and the steps for change identification, assessment, approval and implementation. - The CAPA procedure which describes the process for correcting and preventing events that could adversely affect quality. It defines different action types and outlines how CAPA may be initiated based on deviations, investigations, audits and more. - Both procedures reference SOPs that provide more detailed guidance and are applicable company-wide to maintain quality and compliance with

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 22

    A presentation on

    Change Management
    &
    CAPA

    Presented by
    Nasir Uddin Gazi
    Assistant Manager, QAD
    Renata Limited.
    Change
    Management
    This will be dealt with a SOP.
    SOP NO.: RGF/SOP/QA/004/04
    Title of the SOP: SOP for Change Control Procedure

    Purpose:
    To establish a standard procedure to address a broad set of
    possibilities including changes to
    • product formulation or design,
    • manufacturing instructions,
    • SOPs, test methods and specifications,
    • any new raw materials,
    • upgrades to facilities, utilities, equipment
    • computer systems
    • Even any changes in policy.
    Change control will allow to enable certain changes after comply with
    regulatory requirements.
    Responsibility:
    Responsibility of Department in-charge: Make intra/inter
    department consultation to raise the change proposal and formal
    request to QA to initiate a Change Control Request Form (CCR
    form)

    Responsibility of Quality Assurance Personnel: Support to


    establish a system for controlling, documenting and assessment of
    any change procedure.

    Responsibility of Head of Quality Assurance: Establish a system


    for controlling the changes as per GMP and Regulatory requirement.
    He/she is responsible for making different team for the change
    control process and give initial & final approval of the change
    process.
    Applicability:
    This SOP is applicable for all department of General Manufacturing
    Facility, Renata Limited to implement any type of change which have
    direct or indirect impact on Product quality. It is not applicable for the
    documents where changes of document are controlled by introducing
    new version (e.g. SOP, TP etc).

    Procedure:
    • Proposal
    • Initiation
    • Assessment for GMP impact
    • No. for CCR
    • Approval for Implementation
    • Change management
    Procedure (Cont…)

    Identification, record, classify and critical review of change


    control:

    The process must control any type of change that will have impact on
    SQIPP (Strength, Quality, Identity, Potency and Purity) of the drug
    product.

    Identify the requirement of any significant change required in manufacturing,


    analysis, release and distribution which may includes (but not limited to):

    • New facility validation


    • Equipment qualification change
    • Source of starting material
    • Change in existing processes
    • Changes in laboratory test methods and procedures.
    Procedure (Cont…)

    • Changes associated with product rework


    • Batch Size
    • Changes in labeling & packaging
    • Introduction of new procedures
    • Introduction of new processes
    • Changes to approved applications
    • Document Changes
    • Changes associated with product specifications
    • Changes related to the CAPA system
    • New process validation
    • Changes related with the quality management system,
    • Location
    • Introduction of new products
    • Change critical spare parts.
    • Change in critical service provider. E.g. pest control, calibration etc.
    • Anything which stay in product contact.
    Procedure (Cont…)

    Any one of the organization can propose a change. Initially the


    proposal should be shared with the department head.

    Concern department head will finalize the proposal assessing


    the feasibility. Concern Department head may conduct intra and
    inter (if necessary) department consultation before raising the
    proposal.

    Concern department will initiate change procedure by making a


    formal request to Quality Assurance for issuance of a ‘Change
    Control Request Form (CCR form)’.

    CCR form will be initiated by putting the name of the initiator,


    Department, signature of the initiator along with a short title of
    the change.

    Change request will be registered on the Log register for the


    change control.
    Procedure (Cont…)

    The initiator department will give a brief description about the


    proposed change along with supporting document (if required).

    The initiator department will mention the change type (Temporary or


    Permanent) with remarks.

    Need and justification for the change will be illustrated by the


    concern department.

    Quality Assurance will assess the impact of the change on GMP.


    •If the change has no impact on GMP, then the change will be
    approved by the Head of Quality Assurance and close the
    report.

    •If the change has impact on GMP, then Quality Assurance will
    give a unique number for the CCR and manage the change as
    described below.
    Procedure (Cont…)

    A unique sequential number will put by Quality Assurance Department


    as a reference number of the CCR form which will be structured as
    below: RGF/CCR/XX/YY/ZZZ

    Different department Head will evaluate the proposal and put their
    comments. Also suggest necessary action (e.g. validation study,
    stability study etc.) regarding the change.

    During review if any one disagrees with the proposal, he must justify
    his opinion.

    Head of Quality Assurance will review the proposal. He will also


    suggest for Risk Assessment, if necessary. Risk Assessment will be
    conducted as per SOP No.: RGF/SOP/QA/089/01 by the Risk
    Assessment Team.
    Procedure (Cont…)

    Head of Concern Department will arrange a meeting (if necessary) with


    Risk Assessment Team (if any) and the technical experts to review the
    risk assessment report before set up the action plan for the change
    implementation.

    Considering the review of Risk Assessment report and/or suggestion


    from different Department Head, concern Department Head will finalize
    the action plan with a proposed timeline for the implementation of the
    change and its management. And submit to Quality Assurance for the
    approval of the change proposal for implementation.

    Finally Head of Quality Assurance will review the action plan and
    approve the change proposal for implementation.
    Procedure (Cont…)

    Change Management:

    First step of Change Management plan is the approval of the change to


    administer.

    Originating department will implement the change as per the change


    proposal and action plan mention in the CCR form.

    Concern personnel shall be trained properly (according to Training SOP)


    for the execution of any activity necessary for the implementation of the
    Change.

    Documentation is a part of change control Management plan, hence all


    document should be updated according to the change, which includes:
    Document for Control, SOPs, Qualification Reports, Validation
    Reports, Room data sheet, Others.
    Procedure (Cont…)

    Change management plan will have some follow up task (e.g.


    Validation study, Stability Study, Trend Analysis, Hold time Study
    etc.) to conclude the impact of the change during routine/future
    practice which will be carried out by concern people.

    If the change is a consequence of any quality management activity


    (e.g. deviation, CAPA etc) or this change suggests any further
    quality management activity, reference no. of that activity will be
    mentioned as cross reference.

    After successful completion and review the result of follow up task


    change control will be close by final approval. Head of Quality
    Assurance will review the total report and give final authorization of
    the change.

    Approved change proposal will be implemented and closed within


    agreed timeline. If originating department will unable to do so,
    timeline may be extend by approval of HOD and agreed by Head of
    Quality Assurance with proper justification.
    Procedure (Cont…)
    If change proposal need to be rejected by the originating
    department after approval of the change for implementation,it
    will be handled by raising Deviation Notification Report (As per
    SOP No.: RGF/SOP/QA/002)

    If the implemented change has some relation with any


    Business Partner/contract Manufacturing then the total report
    will be reviewed and authorized by the Business
    partner/Contract Giver.

    Log book will be maintained to issue and close of change


    control. Also Microsoft Excel ‘Data Tracker’ will be maintained
    for the data storage and tracking.

    All changes will be preferably reviewed annually, carried out by


    Quality Assurance.
    CAPA
    This will be dealt with a SOP.
    SOP NO.: RGF/SOP/QA/090/01
    Title of the SOP: SOP for Corrective And Preventive Action
    Purpose:
    To describe a procedure to be used for correction and prevention of any
    event that may/can adversely affect the quality of the product. This is a
    procedure mostly (but not limited to) followed by an investigation and root
    cause analysis.

    Responsibility:
    •Head of Departments: All concerned department heads shall be
    responsible for conducting investigation regarding their departments and
    suggesting possible corrective and preventive action.

    •QA shall be responsible for doing active role in investigation and CAPA
    report preparation.

    •Head of Quality Assurance shall be responsible for the final approval of


    the CAPA report.
    Applicability:
    This SOP will be applicable for taking corrective and preventive action
    against any unexpected event occurred during processing or testing
    which may hamper product quality.

    Procedure:

    Definition:
    There are three types of action related to CAPA.
    1.Correction/Remedial Action: It is the immediate action which
    is taken to manage any non-conformance or deviation instantly.
    2.Corrective Action: It is the action taken to eliminate the
    cause/s responsible for the non-conformity or deviation.
    3.Preventive Action: Action taken to prevent the recurrence of
    the same incident.
    Procedure (Cont…):

    CAPA may be initiated as a result of (but not limited to) following event
    •Deviation
    •Investigation
    •Out of Specification
    •Self inspection
    •Audit
    •Management review/decision
    •System effectiveness improvement
    •Customer complain
    •Reviews: Annual product quality review, Validation review,
    Suppliers performance assessment.
    •Risk Assessment
    Procedure (Cont…)

    Quality Assurance/concern person (or department) will initiate the CAPA


    Form (Annexure- I) against a documented evidence of non-conformity
    with cause/s which need to be corrected, eliminated and prevented.

    Each CAPA will have a unique sequential number as below


    RGF/CAPA/XX/YY/ZZZ

    After initiation of the CAPA form, Quality Assurance will put the
    preliminary information of the CAPA form (Title, Date of Initiation,
    Department name, Source of CAPA with Reference no.).

    Initiator along with a representative from concern department will


    document the immediate action had taken, summery of the root cause/s
    and scope of the CAPA.

    A multi department CAPA team shall be formed under the supervision of


    Head of Quality Assurance to determine the action plan and
    implementation of CAPA.
    Procedure (Cont…)

    CAPA team will propose a action plan to eliminate and prevent the root
    causes which will be reviewed by concerned department heads. During
    determine the action plan, must consider the magnitude of the problem.

    After review the proposed action plan, CAPA team will finalize the
    Action plan which must be agreed by Head of Quality Assurance and
    Head of Manufacturing.

    Fix a time frame for the implementation and Closing of the CAPA
    according to the criticality of the cause and effect.

    Implement CAPA by the time frame.

    If any change recommended by the CAPA, appropriate change


    management will be followed (According to the SOP No:
    RGF/SOP/QA/004)
    Procedure (Cont…)

    Affected procedure and document due to CAPA will be updated


    accordingly by the concern person who will be notified before.

    Conduct proper training for the updated procedure and document to


    the concern persons.

    Before closing the CAPA check the commitment compliance regarding


    CAPA implementation by CAPA team.

    Finally CAPA form shall forward to Head of Quality Assurance for


    review and approval.

    CAPA team can apply for CAPA timeline extension for the CAPAs which
    will not close in time. Time line will be extended only after the approval
    of department head and agreed by Head of Quality Assurance.
    Procedure (Cont…)

    Head of Quality Assurance will review and approve the CAPA for closing
    or extend the CAPA closing timeline.

    A log book will maintain to issuance and closing of CAPA. Also a


    Microsoft Excel Track sheet will maintain for tracking the status of CAPA.

    Quality Assurance will annually review the pattern and trends of CAPA.

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