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    New Microsoft Word Document Daljit

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    tyagisonu9091

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    New Microsoft Word Document Daljit

    Uploaded by

    tyagisonu9091
    5 views2 pages

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    © All Rights Reserved
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    Download as docx, pdf, or txt
    5 views2 pages

    New Microsoft Word Document Daljit

    Uploaded by

    tyagisonu9091

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    Goals for 2020-2021:-

    1. 100% verification of product w.r.t. Pharmacopoeial changes for continues


    supply of products without any failure of system.
    2. Proper evaluation of stability data of new developing products for health
    safety purpose of end user.
    3. Training on QMS as well as regulatory guidelines to the sites core team
    members to understand the industrial requirements.
    4. Laboratory compliance w.r.t. instruments basic level requirements.
    5. New vendors development by perform maximum audits which will help to
    capture the market for branded products of Mankind organization.

    Achievements form Jan 2020 to August 2020


    (Including duration of pandemic condition) :-
    1. Compliance evaluation done for available instruments under laboratory of
    Mankind & Group of company’s w.r.t. the 21CFR compliance, accordingly
    suggested to sites for procurement for new instrument.
    2. Online training imparted for skill enhancement of core team members at
    Mankind sites for investigation of OOS/OOT/ Deviation/ Incident w.r.t.
    regulatory guidelines and for process validation which helps to reduce market
    complaint as proper CAPA’s implemented w.r.t. the identified root cause.
    3. Strengthen to Quality Management System in form of regulatory approach
    has been implemented at site:-
    i) Risk Assessment approach has been implemented at site for Major
    changes.
    Ii) Strengthen Deviation Handling and Investigation procedure at site.
    iii) Major revolution in New Development activities/Tech Transfer activities.
    iv) More than 50 Product technology transferred from existing to alternate
    vendor in-line with compliance.
    4. Started virtual audits for vendor as well as existing sites evaluation w.r.t the
    compliance.
    5. Assignments prepared w.r.t. regulatory approach on various topics for easy
    understanding the concepts to everyone.
    6. Facilitate for outside analysis instead of logistic issues.
    7. With the contribution of CQC team for compliance w.r.t gap assessment at
    site MK 1 & MK 2, got approvals from Ukraine (EU) country.
    8. Approvals of new products like N95 Face Mask, Hand Sanitizer, Surface
    Disinfectant Spray, Vitamin C tablets & other products supporting immunity as
    per the current market demand.
    Current Issues/Gaps and Action plan for FY 2020 -21
    1. Insufficient manpower at all sister concern sites, due to which hurdles are
    here to achieve the compliance level. Evaluation started for actual number of
    manpower for quality department at individual site, Further its management’s
    call to fulfil the same.
    2.

    Goals for 2021-2022:-


    1. Reduction in failure due to human error.
    2. Reduction of overages factor under product having stable result up to shelf
    life.
    3. Reduction under cost for packaging material.
    4. Minimize the paper work.
    5. Reduction of Product Market Complaints
    6. Atomization of equipment/Instrument, at production and QC area focused to
    audit trail review.

    Challenge/Issues and Action plan for FY 2021-22


    1. Old version instruments available at most of the sites, need here site
    management approval for procurement of updated instruments / equipments.
    2.

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