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    GMP Observations in Production

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    Dharmesh Patel
    Quality assurance personnel conduct plant audits to check adherence to cGMP guidelines and fill out checklists. Any abnormalities or discrepancies are reported and corrective actions are reviewed and approved. Critical non-compliances like equipment breakdowns, missing documents, or missing material labels require filing a GMP incident report. The report number follows a standardized format of GIR/XX/YYY. During audits, calibration of equipment like temperature indicators are checked along with maintenance records, sample collection procedures, material storage and labeling, and cleaning records for areas processing chemicals and powders.

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    GMP Observations in Production

    Uploaded by

    Dharmesh Patel
    61 views2 pages
    Quality assurance personnel conduct plant audits to check adherence to cGMP guidelines and fill out checklists. Any abnormalities or discrepancies are reported and corrective actions are reviewed and approved. Critical non-compliances like equipment breakdowns, missing documents, or missing material labels require filing a GMP incident report. The report number follows a standardized format of GIR/XX/YYY. During audits, calibration of equipment like temperature indicators are checked along with maintenance records, sample collection procedures, material storage and labeling, and cleaning records for areas processing chemicals and powders.

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    Quality assurance personnel conduct plant audits to check adherence to cGMP guidelines and fill out checklists. Any abnormalities or discrepancies are reported and corrective actions are reviewed and approved. Critical non-compliances like equipment breakdowns, missing documents, or missing material labels require filing a GMP incident report. The report number follows a standardized format of GIR/XX/YYY. During audits, calibration of equipment like temperature indicators are checked along with maintenance records, sample collection procedures, material storage and labeling, and cleaning records for areas processing chemicals and powders.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    61 views2 pages

    GMP Observations in Production

    Uploaded by

    Dharmesh Patel
    Quality assurance personnel conduct plant audits to check adherence to cGMP guidelines and fill out checklists. Any abnormalities or discrepancies are reported and corrective actions are reviewed and approved. Critical non-compliances like equipment breakdowns, missing documents, or missing material labels require filing a GMP incident report. The report number follows a standardized format of GIR/XX/YYY. During audits, calibration of equipment like temperature indicators are checked along with maintenance records, sample collection procedures, material storage and labeling, and cleaning records for areas processing chemicals and powders.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    GMP Observations in Production

    1]              General procedure:


    1.1              Quality Assurance personnel shall make plant round to check adherence of cGMP and fill up the checklist.
    1.2              AMQA/Executive/Designee shall  review the plant audit observation and after compliance/discussion with
    plant Incharge audit report shall be closed.
    1.3              QA Executive or Designee shall ensure the compliance of the observations
    1.4              There is no need to have advance intimation or area permissions for plant audit.
    1.5              Abnormalities/discrepancies can be complies online by production personnel
    1.6              Abnormalities/discrepancies except check list shall be reported and same shall be attached.
    1.7              In case of following critical noncompliance observed during plant audit AMQA/Executive/Designee shall
    be inform through GMP incidence report.
             a)      Breakdowen of equipment/instrument during production.
    b)      Missing /non availability of controlled document.
    c)      Non availability of material status label.
    1.8              GMP incidence report having ten digit  i.e. GIR/XX/YYY.
    a.           Where first 3 digits is for GMP –Incidence Report GIR fallowed by slash.
    b.          Forth and fifth digit XX represents last two digit of the current year. e.g. (01, 02…99),with slash.
    c.           Sixth, seventh and eight digits (YYY) is sequential no. (001 to 999).
    1.9              Filled GMP incidence report along with corrective& preventive action shall be review and approved by site
    quality head.
    1.10          Incidence of GMP due to any discrepancies shall be reported.
    2]               During plant audit Inspect /Check following points
                            Following Check points shall be thoroughly considered during plant audit.
    2.1         Calibration status of temperature indicators, pressure gauge, online pH meter, vacuum gauge, flow meters.
    2.2          Preventive maintainace records of all manufacturing equipment.
    2.3         Weighing balance calibrated and observations are recorded as per SOP; ensure standard weights are
    calibrated by authorized laboratory.
    2.4         Manufacturing process is strictly fallowed as per controlled BMR and check for online recording. 
    2.5         Samples from relevant stage are sent to Q.C.
    2.6         Dispensing of Raw Material is done as per BMR for quantity, label status and ensure material is kept at
    defined place according to storage condition.
    2.7         Calibration status of equipment displayed near the equipment?
    2.8         Are the status boards of equipment updated? e.g. ready for use, to be cleaned, under maintenances, current
    status of process
    2.9          Usage log book for the equipments available and updated on routine basis
    2.10     Does a manhole of reactors covered?
    2.11     Check the centrifuge bag, filter cloth, Nutch filter cloths stored with proper identification as per their
    respective SOP.
    3]               Check for House keeping of Chemicals and Powder processing area :-
    3.1          Review the area cleaning record as per schedule and SOP
    3.2          Cleaning and maintenances records of air handling system and filters updated
    3.3          Ensure that Floor, Walls, Ceilings and High level surfaces, Light fittings, window/ doors, AC, Air
    inlet/outlets properly maintained and cleaned.
    3.4          Processing area have restricted entry i.e. Entry exit procedure is followed.
    3.5          Ensure that all employee must fallow the gowning procedure.
    3.6          Does Standard Operating Procedure are followed and displayed.

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