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Information @ a Glance        

 General
  • The acronym GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality. A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.
  • Australia has Codes of GMP and Quality System requirements for the manufacture of medicinal products, sunscreen products, human blood and tissues, active pharmaceutical ingredients (APIs) and medical devices. Each Code / Quality System sets out requirements relating to quality management, personnel, premises and equipment, documentation, production, quality control, contract manufacture and analysis, complaints and product recall and self inspection. The observance of these requirements is necessary through all stages of manufacture to consistently provide a high level of assurance of the quality, safety, and efficacy of therapeutic goods.

Technology

  • American medicine cabinets contain a growing choice of non prescription,  over-the-counter (OTC) medicines to treat an expanding range of ailments. OTC medicines often do more than relieve aches, pains and itches.

  •  Some can prevent diseases like tooth decay, cure diseases like athleteís foot and, with a doctorís guidance, help manage recurring conditions like vaginal yeast infections, migraines and minor pain in arthritis. he U.S. Food and Drug Administration (FDA) determines whether   Medicines are prescription or nonprescription. The term prescription (Rx) refers to medicines that are safe.

Market

  • "Dietary supplement" means a product marketed under food law, containing one or more dietary ingredients in a concentrated form, which may also contain other ingredients, presented in a form intended for single or multiple dose administration, including but not limited to tablets, capsules, powders or liquids.

  • All applicable food GMP standards, including those related to (i) qualifications and hygienic practices related to personnel; and (ii) the design, construction, maintenance and sanitation of buildings, facilities, equipment, utensils, dietary products and other ingredients, shall be followed in the manufacturing of dietary supplements.

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