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Good Manufacturing Practice

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Title: Good Manufacturing Practice


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GMP Good Manufacturing Practice
  • What is GMP - Good Manufacturing Practice ?
  • We all know that microorganisms bacteria,
    viruses, protozoan's, fungi, etc.  are present
    everywhere in the atmosphere. What if the tablets
    you are manufacturing or devices you are
    packaging get contaminated by a few harmful
    bacterial cells? Even slight error in the
    concentration of a chemical substance can show a
    different reaction. What if a few milliliters of
    a hazardous chemical is poured into that cough
    syrup? You risk the life of thousands of innocent
    patients who consume your medicine thinking that
    it will cure their diseases. Such an erroneous
    act may compel the government authorities to shut
    down your manufacturing unit. To ensure that a
    scenario like this never occurs, the FDA has
    enforced a regulation Good Manufacturing
    Practice (GMP). The GMP guidelines and principles
    are legal codification of quality and purity that
    must be followed right from intake of raw
    materials to manufacturing, testing and packaging
    of active pharmaceutical ingredients, medical
    devices and other products so that the end user
    gets product in its safest and purest form.
    Over hundred countries have provided their own
    legislation for pharmaceutical, food and biotech
    companies to comply with GMP guidelines and
    principles. The basic concept and guidelines of
    them all remain the same.

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GMP Regulations in Good Manufacturing Practice
  • Almost all the regulations are centered around
    cleanliness, sanitation, efficiency of
    equipments, complaint handling, record-keeping
    and personnel qualifications. Since these
    guidelines are pretty flexible, its helpful for
    business owners and managers to understand the
    requirements in their own way and implement them
    effectively.
  • 1- EquipmentsThe equipments and utensils used
    should be made of appropriate materials and
    design to prevent corrosion, dirt or any external
    chemical agent from altering the composition of
    ingredients used to manufacture a product.2-
    PersonnelThe employees performing various tasks
    must have appropriate educational qualification
    and training. They should wear proper protective
    gear like hand gloves and apron to prevent
    contamination and hazards. Forbid them to consume
    food, drink, tobacco, cigarette smoking within
    the manufacturing premises. 3- Building and
    FacilitiesBuilding that houses the
    manufacturing unit should be of suitable design
    and size to accommodate all the equipments.
    Floors and ceilings should regularly be cleaned.
    Proper sanitation, ventilation and lighting are
    very important for sanitary as well as staff.

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  • 4- Raw MaterialsThe three most important
    things to be considered about raw materials are
    quality, storage and treatment. Make sure that
    the raw materials you purchase are of standard
    quality. Store and treat them properly to avoid
    contamination, heat, cold and moisture. Label
    them and take a small sample to test it for
    purity.5- Manufacturing ProcessEnsure that
    the process you use is proven to produce a
    pharmaceutical product of high quality. It should
    be fully controlled and clearly defined. Any
    change in the process must be evaluated. Each
    employee should be handed a process manual
    written in clear and unambiguous language. 6-
    RecordsKeep the records and results of sample
    tests for every batch so that the complete
    history of the batch, right from the raw
    materials to distribution, can be traced whenever
    required. 7- LabelingLabel is the statement
    of identity for any product. It should clearly
    mention the name of product, ingredients, batch
    number, manufacturing and expiry dates, direction
    for use and warnings. 8- InspectionThe
    Pharmaceutical Inspection Cooperation Scheme
    (PICS) and Pharmaceutical Inspection Convention
    work together to inspect whether or not the
    pharmaceutical companies comply with the GMP
    requirements. If your compliance is poor and many
    deficiencies are noted, your manufacturing unit
    has to be re-audited.

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Contact Us !
Im Schwarzenbach 6 Weil am Rhein Baden-Wurttemberg
-79576 Germany Phone 49(0)7621-76176
Email info_at_gmp7.com
Website http//www.gmp7.com/
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