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    In Process Quality Control (Ipqc) : "Testing"

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    Ayalew Desye
    IPQC (In-Process Quality Control) involves sampling and testing products during manufacturing to monitor quality and prevent errors. It aims to control manufacturing procedures, monitor all quality-affecting aspects, detect human errors, and ensure the final product meets specifications. Tests are conducted using various instruments and are tailored to the specific dosage form, identifying critical steps and parameters to check. This includes assays, dissolution testing, content uniformity checks, and other physical quality tests run at different stages for tablets, liquids, injectables and other dosage forms. Packaging is also tested to validate print accuracy and container integrity.

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    In Process Quality Control (Ipqc) : "Testing"

    Uploaded by

    Ayalew Desye
    1K views10 pages
    IPQC (In-Process Quality Control) involves sampling and testing products during manufacturing to monitor quality and prevent errors. It aims to control manufacturing procedures, monitor all quality-affecting aspects, detect human errors, and ensure the final product meets specifications. Tests are conducted using various instruments and are tailored to the specific dosage form, identifying critical steps and parameters to check. This includes assays, dissolution testing, content uniformity checks, and other physical quality tests run at different stages for tablets, liquids, injectables and other dosage forms. Packaging is also tested to validate print accuracy and container integrity.

    Original Title

    03IPQC

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    IPQC (In-Process Quality Control) involves sampling and testing products during manufacturing to monitor quality and prevent errors. It aims to control manufacturing procedures, monitor all quality-affecting aspects, detect human errors, and ensure the final product meets specifications. Tests are conducted using various instruments and are tailored to the specific dosage form, identifying critical steps and parameters to check. This includes assays, dissolution testing, content uniformity checks, and other physical quality tests run at different stages for tablets, liquids, injectables and other dosage forms. Packaging is also tested to validate print accuracy and container integrity.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    1K views10 pages

    In Process Quality Control (Ipqc) : "Testing"

    Uploaded by

    Ayalew Desye
    IPQC (In-Process Quality Control) involves sampling and testing products during manufacturing to monitor quality and prevent errors. It aims to control manufacturing procedures, monitor all quality-affecting aspects, detect human errors, and ensure the final product meets specifications. Tests are conducted using various instruments and are tailored to the specific dosage form, identifying critical steps and parameters to check. This includes assays, dissolution testing, content uniformity checks, and other physical quality tests run at different stages for tablets, liquids, injectables and other dosage forms. Packaging is also tested to validate print accuracy and container integrity.

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    © All Rights Reserved
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    You are on page 1of 10

    IN PROCESS QUALITY CONTROL (IPQC)

    “TESTING”

    1
    IPQC ...
    • Definition: "It is a planned system in which samples are
    taken and tested at various critical steps during
    manufacturing in accordance with written directions".
    It monitors all the features of the product that may affect
    its quality and prevent errors during processing

    Areas controlled by IPQC


    Manufacturing area
    Packaging area

    2
    PURPOSE
    To control the procedure involved in manufacturing
    To monitor all features which affect the quality
    To detect significant human errors
    To ensure quality of final product
    To monitor and, if necessary, to adjust the process to
    ensure that the product conforms to its specifications
    It sometimes identifies a defective product batch that can
    be corrected by rework
    3
    Various Instruments Used in IPQC Dep’t
    Disintegration apparatus
    Dissolution apparatus
    Analytical balance
    Friability testing apparatus
    pH meter
    Tablet hardness tester
    Chromatographic methods
    UV Spectroscopy
    Karl Fisher Titrimeter
    4
    Conditions for Designing of IPQC Test
    Identify the types of formulation (tab , liquids, ointments)
    Identify the critical steps involved in manufacturing of the
    product
    Identify the specification of parameters which conform the
    parameters are within control
    Define the frequency of checking for each parameter

    5
    IPQC Tests for Various Dosage Forms
    Tablets
    a) Content uniformity
    b) Dissolution test
    c) Assay of active ingredients
    d) Weight variation
    e) Hardness test
    f) Disintegration test
    g) Friability
    6
    IPQC Tests for Various Dosage Forms …
    Syrups & Suspensions
    a) Content uniformity
    b) Assay of active ingredients
    c) pH = affects the stability of the product
    d) Appearance – color , odor, taste
    Product is checked for uniform distribution of color
    absence of air bubbles
    e) Clarity test

    7
    IPQC Tests for Various Dosage Forms …
    INJECTABLES
    a) Content uniformity
    b) Clarity test
    c) pH
    d) Pyrogen test
    e) Stability test
    f) Leakage test
    g) Sterility test
    8
    IPQC Tests for Various Dosage Forms …
    Capsules
    Wt variation
    Assays
    Content uniformity
    Dissolution test
    Disintegration time
    Moisture content

    9
    IPQC Tests for Various Dosage Forms …
    PACKAGING
    Line clearance must be given before starting packaging
    operation
    Print details on labels must be certified
    Leakage testing for bottles, ampoules, vials must be
    performed
    Objectives of Line clearance
    To assure that no traces of previous product
    To assure that correct materials brought for processing/
    packing
    10

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