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    SOP For Handling of Deviations

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    mrugeshj
    This document outlines the standard operating procedure for handling deviations at a pharmaceutical company. It defines responsibilities for reporting and investigating deviations, and the process for classifying, approving, risk assessing, and closing deviations. Planned deviations require pre-approval while unplanned deviations trigger an investigation and corrective actions. The procedure aims to control deviations and ensure they do not negatively impact product quality.

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    © All Rights Reserved
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    SOP For Handling of Deviations

    Uploaded by

    mrugeshj
    7K views4 pages
    This document outlines the standard operating procedure for handling deviations at a pharmaceutical company. It defines responsibilities for reporting and investigating deviations, and the process for classifying, approving, risk assessing, and closing deviations. Planned deviations require pre-approval while unplanned deviations trigger an investigation and corrective actions. The procedure aims to control deviations and ensure they do not negatively impact product quality.

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    SOP for Handling of Deviations

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    This document outlines the standard operating procedure for handling deviations at a pharmaceutical company. It defines responsibilities for reporting and investigating deviations, and the process for classifying, approving, risk assessing, and closing deviations. Planned deviations require pre-approval while unplanned deviations trigger an investigation and corrective actions. The procedure aims to control deviations and ensure they do not negatively impact product quality.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    7K views4 pages

    SOP For Handling of Deviations

    Uploaded by

    mrugeshj
    This document outlines the standard operating procedure for handling deviations at a pharmaceutical company. It defines responsibilities for reporting and investigating deviations, and the process for classifying, approving, risk assessing, and closing deviations. Planned deviations require pre-approval while unplanned deviations trigger an investigation and corrective actions. The procedure aims to control deviations and ensure they do not negatively impact product quality.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 4

    SOP for Handling of Deviations

    1. OBJECTIVE

    To lay down the investigation and control procedure for deviation, which can affect the quality of the
    product, to enable a suitable and prompt action.

    2. SCOPE:

    This procedure is applicable to any deviations reported in any department at XXXX.

    3. RESPONSIBILITIES

    Department / Designation Responsibility


    Concerned Department Executive/ To raise the deviation.
    Officer/ Operator
    Concern Department Head/Designee To review the description and reason for deviation.
    To provide justification/ rationale for deviation.
    To facilitate for investigation of Unplanned deviation and root
    cause analysis.
    To provide target completion date of deviation.
    To perform risk assessment.
    To give justification for extension of deviation if applicable.
    Head - Quality Control (QC)/ To review investigation and root cause of unplanned deviation.
    Designee To review impact analysis of deviation on product quality and
    give approval for proposed deviation.
    To classify deviation.
    To review target completion date.
    To evaluate risk assessment.
    To review implementation status of Corrective Actions.

    4. PROCEDURE:

    4.1. Deviations:

    4.1.1. Planned Deviation: Planned deviations are those, which are planned before it
    happens or executed or which are observed as going to be occurred. These are pre-
    identified and pre-approved with proper justification and covering a specified period of
    time or number of batches. Example: Calibration or validation delayed due to various
    reason.
    4.1.2. Unplanned Deviation: The deviation, which is not, identified when they occur and
    which is detected post occurrence. These deviations may be uncontrolled event in the
    form of non-compliance to the designed system or procedure. This can be critical,
    major or minor in nature due failure of (but not limited to) machine, personnel,
    material, product quality, safety, efficacy, and regulatory compliance and appropriate
    actions to correct the impact of deviation.
    4.1.3. Minor Deviation: Deviation that do not have direct impact on product safety, identity,
    strength, purity, quality and processes involved in the product manufacturing and
    testing. Example: Dealer sample wrongly printed with price.
    4.1.4. Major Deviation: Deviation that may have significant impact on product safety,
    identity, strength, purity, quality and process involved in the product manufacturing
    and testing. Example: Manometer reading in the sampling booth cross the action limit.
    SOP for Handling of Deviations

    4.1.5. Critical Deviation: Deviations has direct impact on product safety, identity, strength,
    purity and quality.

    4.2. Handling of Deviation:

    4.2.1. Deviations shall be intimated to quality assurance department by the initiator


    department immediately.
    4.2.2. Officer Quality or designee shall issue the “Deviation form” with assigning a deviation
    report no. as per point number 4.3.4 and log the deviation in “Deviation log”.
    4.2.3. Deviations shall be initiated for as the following situations:
    – Human error
    – Malfunctioning of an equipment or instrument
    – Deviation from any written procedure
    – Change in FIFO order for Raw materials or packaging materials or finished
    goods.
    – Change of process steps / control limits.
    4.2.4. For all other deviations, SOP for Change Control shall be followed.

    4.3. Initiation of Deviation:

    4.3.1. The concerned department officer/executive/chemist shall fill all the details regarding
    deviations like Description of the event that caused the deviation, Reference
    SOP/Document, Description of the proposed deviation and Justification for the
    deviation.
    4.3.2. The concerned department head/designee shall review and write the comment on
    product impact analysis likely to be caused by the Deviation.
    4.3.3. Quality Head/Designee shall then review the Deviation jointly with concerned
    Department Head/Designee and classify the Deviation.
    4.3.4.Specify the unique number of the Deviation as DN/YYYY/ZZZ
    Where, DN stands for Deviation Number.
    YYYY stands for Year (Like for year 2020)
    ZZZ stands for Sequential Number Like, 001,002 ..... etc..

    4.4. Evaluation of proposed deviation:

    4.4.1. Quality Head/Designee shall evaluate the proposed deviation along with concerned
    Department Head/Designee and other personnel, as may be required to analyse the
    effect of deviation in their respective work area and on the product quality and safety.
    4.4.2. Based on the recommendations of above evaluation, Quality Head/Designee shall
    give approval / non approval for the proposed deviation.
    4.4.3. In case the proposed deviation is not approved, it shall be informed to initiating
    department and the deviation shall be canceled.

    4.5. Risk Assessment:

    4.5.1. Based on the investigation of Deviation, concerned Department Head/Designee along


    with Quality Head/Designee shall review the risk assessment and update the same as
    necessary.
    4.5.2. Quality Head/Designee shall then approve the Risk Assessment.
    4.5.3. Quality Head/Designee may initiate necessary correction action(s) and/or corrective
    action(s) based on the investigation of Deviation.

    4.6. Closure of Deviation:


    SOP for Handling of Deviations

    4.6.1. Quality Head/Designee shall review the action and close out the deviation after
    obtaining satisfactory results. Deviation shall be closed within 30 working days, if not
    closed within target completion date. Initiating department head shall give proper
    justification for the same and time line for closing of deviation. Photocopy of the
    required documents shall be attached with deviation form by initiating departments.
    4.6.2. Deviation related to product shall be closed before release of the batch. Once the
    Corrective action(s) shall be agreed, deviation report shall be closed.

    4.7. Deviation log:

    4.7.1. After approval of deviation, Quality Executive/ designee shall update After approval of
    deviation, QA designee shall update “Deviation log” as per “Deviation log” with status
    and maintained in Quality department.
    4.7.2. Deviation log shall be maintained as per calendar year.

    5. DISTRIBUTION:

    5.1. This SOP (Controlled Copy) shall be distributed to following Department of the
    Plant.

    5.1.1. Quality.
    5.1.2. Production
    5.1.3. Warehouse.
    5.1.4. Engineering
    5.1.5. HR & Admin.

    5.2. Master Copy remains with Quality Department.

    6. ANNEXURES:

    Annexure – I Deviation Form


    Annexure – II Deviation Log

    7. FORMATS:

    Sr. No. Document No. Title

    8. REFERENCE DOCUMENTS:

    Sr. No Reference Detail


    ISO 22716 – Cosmetics – Good Manufacturing Practices – Guidelines on Good
    1.
    Manufacturing Practices
    2. ISO 9001 – Quality Management Systems – Requirements
    3. MNG-PRO-004-00 SOP for Change Control

    9. REVISION HISTORY:

    Revision No. Effective Date Details of changes


    SOP for Handling of Deviations

    00 01/11/2020 New SOP

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