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    OOS Investigation

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    markandey gupta
    The investigation report summarizes an issue where a working standard of mineral oil was not qualified and used for testing product oil. The investigation team reviewed standard test procedures, USP monographs, supplier certificates, and product specifications. They found no requirement to calculate potency for the raw material, but product specifications required potency calculation. Comparative testing showed results were within analytical variation when using the same raw material lot as a working standard. Corrective actions included updating test procedures and generating stability data to define the six-month working standard shelf life.

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    OOS Investigation

    Uploaded by

    markandey gupta
    438 views5 pages
    The investigation report summarizes an issue where a working standard of mineral oil was not qualified and used for testing product oil. The investigation team reviewed standard test procedures, USP monographs, supplier certificates, and product specifications. They found no requirement to calculate potency for the raw material, but product specifications required potency calculation. Comparative testing showed results were within analytical variation when using the same raw material lot as a working standard. Corrective actions included updating test procedures and generating stability data to define the six-month working standard shelf life.

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    OOS investigation

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    The investigation report summarizes an issue where a working standard of mineral oil was not qualified and used for testing product oil. The investigation team reviewed standard test procedures, USP monographs, supplier certificates, and product specifications. They found no requirement to calculate potency for the raw material, but product specifications required potency calculation. Comparative testing showed results were within analytical variation when using the same raw material lot as a working standard. Corrective actions included updating test procedures and generating stability data to define the six-month working standard shelf life.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    438 views5 pages

    OOS Investigation

    Uploaded by

    markandey gupta
    The investigation report summarizes an issue where a working standard of mineral oil was not qualified and used for testing product oil. The investigation team reviewed standard test procedures, USP monographs, supplier certificates, and product specifications. They found no requirement to calculate potency for the raw material, but product specifications required potency calculation. Comparative testing showed results were within analytical variation when using the same raw material lot as a working standard. Corrective actions included updating test procedures and generating stability data to define the six-month working standard shelf life.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 5

    Page 1 of 5

    PSYCHOTROPICS INDIA LIMITED


    Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

    Attachment-II

    Investigation Report
    Reference Deviation No.:DV/20/003
    Date: 27/10/2020

    Detail of Observation

    Working standard of mineral Oil was not qualified and used for testing of product Oilatum Bar and
    Oilatum Kids Bar.

    Investigation Team
    S.No. Name of Person Department & Designation Role
    1 Mr. S.P. Singh Manager Quality Control Lead Investigator
    2 Mr. Ajay Singh Asst Manager, Quality Assurance Investigator

    Detail of Investigation
    Page 2 of 5

    PSYCHOTROPICS INDIA LIMITED


    Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

    Attachment-II

    Investigation Report
    Reference Deviation No.:DV/20/003
    Date: 27/10/2020

    In view of said observation the following details area are review to find out the root cause of observed
    deviation.
    1-Review the STS and STP for raw material.
    2- Review the USP Monograph
    3-Review the Supplier COA
    4- Review of STS and STP of Finish Products
    5- Working standard qualification procedure.

    1-Review of STS and STP of Raw Material: During review of STP its found that no working
    standard required to test the raw material Mineral Oil USP and STP does not state to calculate the
    potency of Material Oil hence no need of working standard required to analyzed the raw material.
    Further extended the investigation review the raw material USP monograph.

    2-Review the USP Monograph: Review the Mineral Oil USP monograph for raw material testing
    and there is no test procedure define to calculate the potency calculation of the raw material and
    Other USP test parameter complies in existing STS and STP of raw material hence extended the
    investigation with discussion of manufacturer.

    3-Review of Supplier COA (Mineral Oil USP) : Raw Material Mineral Oil supplied by Savita Oil
    and review the manufacturer COA and it is observed that Raw material tested as per USP. There is
    No test procedure define for potency calculation in mineral Oil hence manufactured does not provide
    potency.

    4- Review of STS and STP of Finish Products : STS and STP of Oilatum Bar and Oilatum Kids
    Bar reviewed and test procedure define the potency calculation for Mineral Oil due to Label Claim
    mention of Product Pack as-
    Mineral Oil 7.5%
    To quantify the % qty of finish product, potency calculation has been done for each batch using the
    raw material (Mineral Oil USP) as a working standard with considering the potency 100%. Working
    standard provided the validity 6 Month.

    5-Working standard qualification procedure: Working standard SOP reviewed and procedure
    stated for validity of working standard is 06 month and verified all available working standard
    qualified against the reference standard. Since in this case due to non availablibility of Reference
    standard Raw material treat as working standard with considering the potency 100% and used for
    testing of finish product to calculate the % qty.

    Also check the available literature it is identified that Mineral oil are the fractions of hydrocarbons
    Page 3 of 5

    PSYCHOTROPICS INDIA LIMITED


    Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

    Attachment-II

    Investigation Report
    Reference Deviation No.:DV/20/003
    Date: 27/10/2020

    naturally occurring in crude petroleum & collected during purification. It’s composition always vary
    because of varying proportions of various hydrocarbons in this mixture. Therefore pharmacopeia
    differentiate on the basis of weight/ml & viscosity only to light/heavy liquid paraffin & assay test is
    also not mentioned. In the same way USP reference available for qualitative use. Using the USP
    reference we can’t establish WS through comparison as mass & NMR both will vary because of
    presence of different ratio of hydrocarbon fractions.

    Further this issue has been discuss with customer and they have suggested that following to be
    reviewed-
    1. Analysis to be performed using current Mineral oil RM as WS and same lot of mineral oil
    added in the batch.
    2. Mineral Oil WS retest frequency 6 M require documented evidences.

    Based On above comments further investigation extended and analysis to be perform and data
    generated to identify the gap below data has been generated using the same lot of raw material as
    WS added in batch.

    Comparative study has been performed on dated 18/12/2020.


    Product Batch No Batch No of Raw Assay Assay using the same Working
    Name Material used in (WS in lot of raw material standard
    manufacturing used ) used in manufacturing details
    of product of product
    Oilatum Bar BSP1642 0000045498 100.74 99.03 Mfg:29/1
    0/2020
    Use
    Before:28
    /04/2021
    Conclusion: Comparison of test results for both working standard and material used in batch
    manufacturing treated as working standard and test results indicate that within the analytical
    variation.

     Comparison study of Naphthalene AR and Napthalene RS done and comparision details as-
    Page 4 of 5

    PSYCHOTROPICS INDIA LIMITED


    Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

    Attachment-II

    Investigation Report
    Reference Deviation No.:DV/20/003
    Date: 27/10/2020

    Comparison Naphthalene AR Naphthalene RS


    Parameter
    Molecular Weight 128.17 128.17

    Molecular Formula C10H8 C10H8

    Chemical Structure

    CAS No 91-20-3 91-20-3

    Conclusion: On basis of comparative study of Napthalene AR and Napthalene RS both are similar in
    molecular weight, formula and chemical structure. However to comply the USP requirement
    Napthalene RS shall be used to test the Limit of Polymorphic test define in Raw Material
    Specification.

    Probable Root Cause

    Due to unavailability of reference standard and Potency calculation not official in any pharmacopeia.

    Impact Assessment
    Refer Attachment I.

    CAPA
    Corrective Action-
    1. STP to be updated to define the same lot of raw material used for testing of finish products.
    2. Stability Data to be generated up to define the shelf life 6M.
    Page 5 of 5

    PSYCHOTROPICS INDIA LIMITED


    Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

    Attachment-II

    Investigation Report
    Reference Deviation No.:DV/20/003
    Date: 27/10/2020

    3. Naphthalene RS shall be used to qualify the working standard for Naphthalene and use for Limit of
    Polymorphic test in raw material ( Mineral Oil USP)
    Preventive Action-
    1-Verified the qualification status of other available working standard
    2- Training to be provided to concern person involve in preparation of STS and STP to identify the
    such type of gaps (Uses of Non-qualified WS).

    CAPA TCD – 31/03/2021

    Sr. No. Investigato Departmen Designation Role Sign/Date


    r Name t

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