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 [phone]
Email info_at_gmp7.com
Website http//www.gmp7.com/
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