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    Change Control Matrix For Facility Change

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    Prem Goel
    This document outlines a change control analysis matrix for an API manufacturing facility. It lists various types of potential changes including building construction, equipment changes, and quality processes. For each type of change, it indicates which approval and documentation steps are required, such as SOP changes, training, drawings, regulatory approvals, and stability studies. The matrix helps to systematically analyze change control requirements.

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    Change Control Matrix For Facility Change

    Uploaded by

    Prem Goel
    512 views2 pages
    This document outlines a change control analysis matrix for an API manufacturing facility. It lists various types of potential changes including building construction, equipment changes, and quality processes. For each type of change, it indicates which approval and documentation steps are required, such as SOP changes, training, drawings, regulatory approvals, and stability studies. The matrix helps to systematically analyze change control requirements.

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    HEART OF GMP AND CAPA IS THE CHANGE CONTROL PROCESS

    Original Title

    Change Control Matrix for Facility Change

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    This document outlines a change control analysis matrix for an API manufacturing facility. It lists various types of potential changes including building construction, equipment changes, and quality processes. For each type of change, it indicates which approval and documentation steps are required, such as SOP changes, training, drawings, regulatory approvals, and stability studies. The matrix helps to systematically analyze change control requirements.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    512 views2 pages

    Change Control Matrix For Facility Change

    Uploaded by

    Prem Goel
    This document outlines a change control analysis matrix for an API manufacturing facility. It lists various types of potential changes including building construction, equipment changes, and quality processes. For each type of change, it indicates which approval and documentation steps are required, such as SOP changes, training, drawings, regulatory approvals, and stability studies. The matrix helps to systematically analyze change control requirements.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    API MANUFACTURING FACLITY CHANGE CONTROL ANALYSIS MATRIX

    SOP Changes Training Drawing Qualification of Equip / Utility Pre approval from Regulatory body Change being effected intimation to reg Information to Annual update Stability Studies Approval from Reg Aff dept

    A) Building of Mfg Block and ware house 1) Effecting Entry and gowning procedure 2) Effecting Utility system that are related to Quality attribute of product e.g HVAC,WATER etc 3) Effecting Man and Material movement 4) Effecting Equipment Layout with relocation of Equipment X X X X X X X

    X X X

    X X X X X X

    X X X X

    B) Building of QC C) Building of Microbiological Lab E) Manufacturing Equipment

    X X

    X X

    API MANUFACTURING FACLITY CHANGE CONTROL ANALYSIS MATRIX


    SOP Changes Training Drawing Qualification of Equip / Utility Pre approval from Regulatory body X X X QC Instrument Critical Utility X X X X X X X X X X Change being effected intimation to reg X X Information to Annual update Stability Studies Approval from Reg Aff dept X

    1 2 3

    like to like Capacity Change Change Operating Principal

    X X

    DR PREM R GOEL BSc,B.Pharm,M.Pharm[India] MS,Ph.D[Pharma][USA]MBA[USA]MIQA[UK] drpremrgoel@gmail.com Skype:gaoposher goelngoelassociatesplc@gmail.com MSN MESSENGER :drpremrgoel1947@hotmail.com 00 91 7600134939 / 9327316198

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