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IPQC: Definition:-

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Title: IPQC: Definition:-


1
  • IPQC Definition-
  • Checks performed during production in order to
    monitor and, if necessary, to adjust the process
    to ensure that the product conforms to its
    specifications. The control of the environment or
    equipment may also be regarded as a part of
    inprocess control.
  • In-process controls are usually performed within
    the production area. The performance of such
    in-process controls should not have any negative
    effect on the quality of the product or another
    product.

2
  • IPQC-
  • In-process inspection and testing should be
    performed by monitoring the process or by actual
    sample analysis at defined locations and times.
    The results should conform to established process
    parameters or acceptable tolerances.
  • Work instructions should delineate the procedure
    to follow and how to use the inspection and test
    data to control the process.

3
  • Introduction-
  • IPQC is concerned with providing accurate,
    specific, and definite description of procedures
    to be employed from the receipt of raw materials
    to the release of finished dosage forms.
  • It is a planned system to identify the materials,
    equipment, process, and operations.
  • In general the in process control procedures are
    usually rapid and simple tests or inspections
    that are performed when the manufacturing of a
    product batch is in progress.

4
  • It is an imp function of IPQA programme to ensure
    that the finished dosage forms have uniformity,
    purity, and quality within batch and between
    batch.
  • Is accomplished by identifying critical steps in
    manufacturing and controlling them within defined
    limits.

5
  • IPQC aims to increase the assurance of batch
    uniformity.
  • There must be written procedure describing the
    control and test or examination to be conducted.
  • In process specification/controls must be
    rational and consistence with the finished
    product specification.
  • They derived from previous validated process
    variations.

6
OBJECTIVE
  • To minimize the human errors.
  • Provides accurate, specific, and definite
    description of the procedure to be employed.
  • To detect the errors if and when it does occur.
  • Corrective action instituted by people.
  • To pin point the responsibility to the personnel
    involved in the operation of the entire process.
  • To enforce the flow of manufacturing and packing
    operations according to established routes and
    practice.
  • Rigidly followed.
  • Should detect any abnormality immediately and at
    the same time indicate the kind of action needed
    to correct the problem.

7
DIFFERENT TYPES OF IN-PROCESS CONTROL
  • Environmental control
  • Building and equipment control
  • Control of records
  • Manufacturing control
  • Packaging control
  • Labeling control
  • Warehousing control
  • Finished product control

8
IPQC on sterile product, parenteral preparation
and sterile ophthalmic preparations.
  • General-
  • Sterile products being very critical and
    sensitive in nature, a very high degree of
    precaution, prevention and preparation are
    needed.
  • Dampness, dirt, and darkness are to be avoided to
    ensure aseptic condition.
  • Environmental Monitoring and Environmental
    control-
  • The recommended frequencies of periodic
    monitoring shall be as follows
  • Particulate monitoring in air - 6 Monthly

9
  • HEPA filter integrity testing(smoke testing)
    -Yearly.
  • Air changes rates - 6 Monthly
  • Air pressure differentials - Daily.
  • Temperature and humidity - Daily.
  • Microbiological monitoring by settle plate and/or
    swabs in aseptic areas daily, and at decreased
    frequency in other areas.
  • There shall be written environmental monitoring
    programme and microbiological results shall be
    recorded.

10
  • Recommended limits for microbiological monitoring
    of clean areas in operation are as given in the
    table below

Grade Air sample Cfu/m3 Settle plates (dia.90 mm) Cfu/2 hrs. Contact plates (dia.55 mm) Cfu/plate Glove points (five fingers) cfu/gloves
A lt1 lt1 lt1 lt1
B 10 5 5 5
C 100 50 25 -
D 500 100 50 -
11
  • Appropriate action shall be taken immediately if
    the result of particulate and microbiological
    monitoring indicates that the counts exceeds the
    limits.
  • The SOP shall contain corrective action.
  • Sanitation-
  • There shall be written procedure for the
    sanitation of sterile processing facilities.
  • Employees carrying out sanitation of aseptic
    areas shall be trained specially for this
    purpose.
  • Different sanitation agents shall be used in
    rotation

12
  • Equipment-
  • SOP shall be available for each equipment for its
    calibration and operation and cleaning.
  • Gauges and other measuring devices attached to
    equipment shall be calibrated at suitable
    interval against a written programme.
  • Water and steam systems-
  • Potable water - meeting microbiological
    specification of not more than 500 cfu/ml and
    indicating absence of individual pathogenic
    micro-organism.

13
  • Purified water prepared by demineralization
    shall meet the microbiological specification of
    not more than 100 cfu/ml and indicates absence of
    pathogenic micro-organism in 100 ml.
  • Water for injection shall be prepared from
    potable water or purified water meeting the above
    specification by distillation.
  • WFI shall meet microbiological specification of
    not more than 10 cfu/100 ml.
  • Bulk solution of liquid parenteral shall be made
    in WFI.
  • It also meets IP specification for WFI.

14
  • Water for non injectable sterile products
  • Like eye drops shall meet IP specification for
    purified water.
  • In addition microbiological specification of not
    more than 10 cfu/100ml and absence of pseudomonas
    aeruginosa and e. coli in 100 ml shall also meet.
  • Steam coming in contact with the product, primary
    containers and other products.
  • Contact surface shall be sterile and Pyrogen
    free.
  • The steam condensate shall meet microbiological
    specification of not more than 10 cfu/100ml.

15
  • Manufacturing process-
  • Bulk raw material shall be monitored for
    bio-burden periodically.
  • Bio-burden of bulk solution prior to membrane
    filtration shall be monitored and a limit of not
    more than 100 cfu/ml is recommended.
  • Gases coming in contact with the sterile product
    shall be filtered through two 0.22 µ filters
    connected in series.
  • These filter shall be tested for integrity.

16
  • Sterilization (autoclaving)-
  • Sterilization process shall be validated
    appropriately.
  • The validity of the process shall be verified at
    regular interval, but at least annually.
  • Whenever significant modification have been made
    to the equipment and product, records shall be
    maintained thereof.
  • The use of biological indicator shall be
    considered as an additional method for monitoring
    the sterilization.

17
  • Sterilization ( By Dry Heat )-
  • Each heat sterilization cycle shall be recorded
    on a time/temperature chart of a suitable size by
    appropriate equipment of the required accuracy
    and precision.
  • The position of temperature probes used for
    controlling and/or recording shall be determined
    during the validation.
  • Sterilization ( By Moist Heat )-
  • Both the temp and pressure shall be used to
    monitoring the process.

18
  • Control instrumentation shall normally be
    independent of monitoring instrumentation and
    recording charts.
  • System and cycle fault shall be registered by the
    system and observed by the operator.
  • Frequent leak test done on the chamber during the
    vacuum phase of the cycle.
  • Product container and closures-
  • All container and closures intended for use shall
    comply with the pharmacopoeia and other specified
    requirement.

19
  • Suitable sample sizes, specification, test
    methods, cleaning procedures, sterilization
    procedures, shall be used to assure that
    container and closures other components part of
    drug packages are suitable are not reactive,
    additive, absorptive, or leachable.
  • Finished product control-
  • Checking the bulk solution before filling, pH,
    color and completeness of solution.
  • Checking the filled volume of liquid or filled
    weight of sterile powder for injection in the
    final container at the predetermined interval
    during filling operation.

20
  • Testing for the leakage of flame sealed ampoules.
  • Subjecting the product to physical examination,
    for appearance, clarity, particulate
    contamination.
  • Sterility testing procedure- determines
  • Physical condition of testing room.
  • Laboratory procedure for handling sterile
    samples.
  • Use of UV lights.
  • No. of units tested per batch.
  • Procedure for identifying test media with
    specific batches.

21
  • Pyrogen testing procedure.
  • Determine if animal involved in positive Pyrogen
    test are withdrawn from use for the required
    period.
  • Indicators
  • Determine type of indicator used to assure
    sterility, such as lag thermometer, peak control,
    test cultures, biological indicators.
  • If biological indicators are used, review the
    current USP on sterilization and biological
    indicators.
  • In some cases testing biological indicators may
    become all or part of the sterility testing.

22
  • Particulate matter testing-
  • Particulate matter consist of extraneous, mobile,
    undissolved substance, other than gas bubbles,
    unintentionally present in parenteral solution.
  • Cleanliness specification or levels of non-viable
    particulate contamination must be established.
  • The levels of particulate contamination in
    sterile powder are generally greater than in LVP.
  • LVP solution are filtered during the filling
    operation.

23
IPQC ON ORAL LIQuIDS
  • Building and equipment-
  • Manufacturing area shall have entry through
    double door air lock facility.
  • It shall be made by fly proof by use of fly
    catcher and/or air curtain.
  • Tank, container, pipe work and pumps shall be
    designed and installed so that they can be easily
    cleaned and sanitized.
  • Purified water-
  • The chemical and microbiological quality of
    purified water used shall be specified and
    monitored routinely.

24
  • The microbiological evaluation include testing
    for absence of pathogens and shall not exceeds
    100 cfu/ml.
  • There shall be written procedure for operation
    and maintenance of the purified water system.
  • Care shall be taken to avoid the risk of
    microbial proliferation with appropriate methods
    like recirculation, use of UV treatment,
    treatment with heat and sanitizing agent.

25
  • Manufacturing-
  • Care shall be taken to maintain the homogeneity
    of emulsion by use of of appropriate stirrer
    during filling.
  • Mixing and filling processes shall be specified
    and monitored.
  • The primary packaging area shall have an air
    supply, which is filtered through 5 micron
    filters.
  • The temp of the area shall not exceed 30 .C

26
  • Finished product protocol-
  • Checking the bulk solution before filling, pH,
    color, sedimentation volume, viscosity
    completeness of solution.
  • Use of water for cleaning shall be restricted
    controlled.
  • Routinely used disinfectants are suitable for
    sanitizing the different areas.
  • Equipments-
  • Suitable check weights, spray testing machines,
    labeling machines shall be provided in the
    equipment.

27
  • All the equipment shall be suitably calibrated
    and their performance validated on receipt and
    thereafter periodically.
  • Manufacture-
  • There shall be an approved master formula records
    for the manufacture of metered dose inhalers.
  • All propellants, liquids gases shall be
    filtered through 2 µ filters to remove particle.

28
IPQC ON ACTIVE PHARMACEUTICAL INGREDIENTS.
  • In process controls for chemical reaction may
    includes the following
  • Reaction time or reaction completion
  • Reaction mass appearance, clarity, completeness
    or pH solution.
  • Reaction temperature.
  • Concentration of the Reactant.
  • Assay or purity of the product.
  • Process completion check by TLC/any other means.

29
  • In process controls for physical operation may
    includes the following
  • Appearance and color.
  • Uniformity of the blend.
  • Temperature of a process.
  • Concentration of a solution.
  • Processing rate or time.
  • Particle size analysis.
  • bulk / tap density.
  • pH determination.
  • Moisture content.

30
IPQC ON METERED DOSE INHALERS.
  • General-
  • Manufacture shall be done under condition which
    shall ensure minimum microbial and particulate
    contamination.
  • Assurance of the quality of components and the
    bulk products is very important, where medicament
    are in suspended state, uniformity of suspension
    shall be established.
  • Building and civil work-
  • The manufacturing area shall be segregated into
    change rooms for personnel, container preparation
    area, bulk preparation filling area, quarantine
    area, and spray testing packing area.

31
  • Environmental condition-
  • The requirements of temperature and humidity in
    the manufacturing area shall be decided depending
    on the type of product and propellant handled in
    the facility.
  • There shall be difference in room pressure
    between the manufacturing area and the supported
    areas that is not less than 15 Pascal.
  • Written scheduled for monitoring temp, humidity.
  • Sanitation-
  • Written procedures for the sanitation of the MDI
    manufacturing facility.
  • Care taken to handle residues and rinses of
    propellants.
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