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Good Manufacturing Practice Good Manufacturing Practice (GMP) is a multi-disciplinary approach to manufacturing medicines which aims to ensure that they are consistantly manufactured to a specific and pre-determined level of quality and safety. As such, GMP is primarily concerned with the control of production processes and the analysis and tests required, via Quality Control, to control and confirm the quality of the medicines produced. Compliance to the principles of GMP is recognised worldwide by national authorities as a legislative requirement for manufacturers of medicines. Background The requirements of GMP systems for the manufacture of medicines were first published in the early 1970s and they continue to be revised and updated in the light of technological progress. In Europe the basic principles of GMP are now contained in Directive 91/356/EEC which specifies the key requirements in areas such as Personnel (qualifications, experience, training), Premises and equipment (design, layout, hygiene, maintenance), Documentation (specifications, manufacturing instructions, test methods, batch records), Production (standard operating procedures, validated processes), Quality Control (laboratories, testing and approval of raw materials and finished products), Post marketing (complaints processing, recall systems), Work contracted out (control of subcontractors), Self inspection (audit programmes). Bioforce Manufacturing & GMP At Bioforce we recognise the important role that GMP plays in meeting our aim to manufacture high quality holistically standardised herbal medicines. Bioforce herbal medicines, including our fresh herb tinctures and tincture tablets, are manufactured at our facility in Roggwil, Switzerland. Surrounded by the fields in which are grown our own organic fresh herbs, the production facility has a long history of being licensed by the Swiss medicines authorities in recognition of its compliance with pharmaceutical GMP standards. The site is subject to regular inspection by the Swiss authorities in order to maintain its GMP certification. The bulk herbal medicines are filled into retail packs at our Irvine site. This also operates to pharmaceutical GMP standards and is licensed by the UK national medicines authority, The Medicines and Healthcare Products Regulatory Agency, formerly the MCA. Like Bioforce (Switzerland) we are also subject to regular GMP inspections in order to continue our GMP certification. Holistic Standardisation and GMP The quality of the finished herbal medicine is dependent upon the quality and consistency of the harvested herbs and the manufacturing processes used to convert the herbs into finished product. Holistic standardisation and GMP provide the means to deliver this consistency. Holistic standardisation takes the principles of GMP and applies them to the cultivation of our herbs: this is called Good Agricultural Practice (GAP). Using trained gardeners who carefully select healthy seeds and then sowing, cultivating and harvesting according to organic growing protocols we can achieve high levels of uniformity in our crop of herbs from one harvest to the next. Holistic standardisation and GMP therefore combine to reduce the variability in the levels of plant constituents, thus providing greater assurance of the amounts of active ingredients in each dose of herbs in the finished medicinal product. This is backed up by exhaustive quality control testing on the freshly harvested herbs to ensure that the levels of active ingredients and all the smaller components present, via the unique plant fingerprint, are up to specification. The net result of the holistic cultivation process is a harvested herb of uniform quality and content. In converting the freshly harvested herb into a medicinal product the principles of GMP are used to standardise the manufacturing and testing processes to the extent that the finished product is reliably consistent batch-to-batch. This delivers a consistently therapeutic product to the consumer from one purchase to another. 1247 |
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