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    Masterformularecord 180319024817

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    Mucharla Praveen Kumar
    The document discusses the Master Formula Record (MFR), which: 1) Is a master document that contains all information about the manufacturing process for a pharmaceutical product, including ingredients, equipment used, calculations, and quality checks. 2) Is prepared by the research and development team and used as a reference standard for batch manufacturing. 3) Includes detailed instructions for each step of the manufacturing and packaging processes, storage conditions, theoretical and actual yields, and requires authorization from production and quality heads.

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    Masterformularecord 180319024817

    Uploaded by

    Mucharla Praveen Kumar
    2K views20 pages
    The document discusses the Master Formula Record (MFR), which: 1) Is a master document that contains all information about the manufacturing process for a pharmaceutical product, including ingredients, equipment used, calculations, and quality checks. 2) Is prepared by the research and development team and used as a reference standard for batch manufacturing. 3) Includes detailed instructions for each step of the manufacturing and packaging processes, storage conditions, theoretical and actual yields, and requires authorization from production and quality heads.

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    The document discusses the Master Formula Record (MFR), which: 1) Is a master document that contains all information about the manufacturing process for a pharmaceutical product, including ingredients, equipment used, calculations, and quality checks. 2) Is prepared by the research and development team and used as a reference standard for batch manufacturing. 3) Includes detailed instructions for each step of the manufacturing and packaging processes, storage conditions, theoretical and actual yields, and requires authorization from production and quality heads.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    2K views20 pages

    Masterformularecord 180319024817

    Uploaded by

    Mucharla Praveen Kumar
    The document discusses the Master Formula Record (MFR), which: 1) Is a master document that contains all information about the manufacturing process for a pharmaceutical product, including ingredients, equipment used, calculations, and quality checks. 2) Is prepared by the research and development team and used as a reference standard for batch manufacturing. 3) Includes detailed instructions for each step of the manufacturing and packaging processes, storage conditions, theoretical and actual yields, and requires authorization from production and quality heads.

    Copyright:

    © All Rights Reserved
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    of 20

    Assignment On

    MASTER FORMULA RECORD


    Submitted To Submitted By

    Prof. Sanju Nanda Ritu


    M. Pharma (2nd sem)
    DRA
    Roll no. 1850
    MASTER FORMULA RECORD
     Master Formula Record (MFR) is a master document for any
    pharmaceutical product.
     MFR contains all information about the manufacturing process
    for the product.
     MFR is prepared by the research and development team of the
    company.
     MFR is used as reference standard for preparing batch
    manufacturing record (BMR) by manufacturing units.
     MFR is also called Master Manufacturing Record, Master
    Production Record.
    Definition

    “A document or set of documents specifying


    the starting materials with their quantities
    and the packaging materials, together with a
    description of the procedures and precautions
    required to produce a specified quantity of a
    finished product as well as the processing
    instructions, including the in-process
    controls.”
    Continued…

     There shall be Master Formula records relating to all


    manufacturing procedures for each product and batch size to be
    manufactured. These shall be prepared and endorsed by the
    competent technical staff i.e. head of production and quality
    control.
     MFR plays an important in consistency for each batch
    manufacturing.
    MFR should include -
    Product Details :
    • Name, logo and address of the manufacturing company.
    • Dosage form name.
    • Brand name.
    • Generic name.
    • Product code
    • Label claim of all ingredients
    • Product description
    • Batch size
    • Pack size and packing style
    …CONTINUED

    • Shelf life
    • Storage conditions
    • MFR number and date
    • Supersede MFR number and date
    • Effective batch number
    • Authorization by the production and quality assurance
    head
    …CONTINUED

    Flow Chart: Steps of the manufacturing process to be


    monitored. Flowchart of the material movement from
    dispensing to the final product to stores.
    Equipment: Create a list of all required equipment and
    machines required in the manufacturing process with their
    capacity.
    Special instructions: Write down the precautions special
    instructions to follow during the product manufacturing and
    packing and these should also be added in the batch
    manufacturing formula.
    …CONTINUED

    Calculations: Include the calculation steps of all active


    materials to get the 100% of the active material. The
    calculation shall be done using water or LOD to get 100%
    potency.
    Manufacturing Process: Write all steps in all stages of
    the manufacturing process. All process steps like shifting,
    milling, lubricating, granulation, compression and coating
    should be written in detail including the process time and
    yield.
    It also include atmospheric conditions as temperature,
    humidity, and storage conditions for every step.
    …CONTINUED

    Packing Process: List of all packing materials with their


    quantity is written. Line clearance, reconciliation of printed
    and unprinted packing materials should be included in
    details.
    Yield: Include the theoretical, actual yield and acceptance
    limit of the batch.
    Procedure to prepare a Master Formula
    Record:

     A Master Formula Record is either prepared based upon


    experience of competent qualified staff
    like manufacturing chemist or analytical chemist or
    prepared based upon batch manufacturing record of a
    batch size.
     We can’t ignore Master formula record at any level. Once
    Master Formula Record is prepared, it is transferred to
    previous staff to new staff. It is followed as standard
    documents for processing a batch. Master Formula record
    is consider as standard for making a Batch Manufacturing
    Record.
    SOP for preparation of the Master
    Formula Record:
    RESPONSIBLE DEPARTMENTS:
    Primary Responsibility:
    F&D and Production Department
    Secondary Responsibility:
    Quality Assurance Department
    ACCOUNTABILITY:
    Head-Quality Assurance shall be responsible for
    implementation of SOP.
    STEPS TO PREPARE A MASTER FORMULA
    RECORD:
     Production Department in association with F&D, shall
    prepare MFR.
     MFR shall prepared as per the format attached with this
    SOP.
     MFR shall be divided into two parts:
     Packaging part
     Manufacturing part
     The first page of both the sections shall have
    following details:
    Name, address and logo of the company
    Dosage form
    Brand name
    Generic name
    Product code
    Label claim : this should include all ingredients and
    text included in product permission
     Product Description
     Batch Size
     Pack Size
     Shelf Life
     Storage conditions
     Drug Schedule: whether schedule H or schedule G drug.
     Superseded Master card number and Date.
     Present Master card number and Date.
     Present Master card effective Batch number.
     Reference of changed control number.
     There shall be authorization of Master Formula Record by all
    the responsible members
     The secondary page of manufacturing section shall
    include-Process steps to be monitored.
     Subsequent pages shall include the processes to be
    monitored. The stage wise movement of material in a
    form of flow chart.
     The list of equipment, machines ,utensils to be used, shall
    be described.
     The subsequent page shall include any special precautions
    to be taken for the product during manufacturing and
    packing. The same page should also include Batch
    Manufacturing Formula.
     Batch Formula should have the following columns:
     Serial number
     Name of ingredients
     Reference of specifications of ingredients
     Quantity to be added (in mg/ml or per tablet or per
    capsule or per gm. as the case may be)
     Overages to be added(in %)
     Quantity to be added per batch or per lot
    Below that give the calculation step for every active
    material, ensuring that the active material shall be
    compensated for assay values less than 100% which could be
    due to less potency or higher moisture content.
    • At the end of every important stage, include a statement of
    the yield with the acceptable limits.
    • Include in-process quality checks during and at the end of
    important steps and stages with their limits.
    • The process shall include the process equipment to be used.
    The methods or the reference of the methods/procedures to
    employed for preparing, cleaning, assembling,operating the
    various equipments shall be given.
    • Include detailed stepwise processing instructions(example:
    checks on materials, pretreatments, sequence for adding
    materials, mixing times, temperatures, humidity etc.)
    • Includes the requirements for storage conditions of the
    products.
    • The packaging part of MFR should include complete list of all the
    packaging materials required for a standard batch size,including
    quantities,sizes and types.
    • Include line clearance checking during batch cording and batch
    packaging operations.
    • Includes reconciliation of printed and unprinted packaging
    materials with acceptable limits.
    • Includes destruction of excess or rejected printed packaging
    materials
    • Includes description of packaging operation including any significant
    subsidiary operations and equipments to be used.
    THANK YOU

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