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Herbal medicines's quality control according to GMP-WHO standard At Danapha Pharmaceutical Joint Stock Company
26/10/2016
Danapha Pharmaceutical Joint Stock Company is one of the first companies getting Certificate of conformity with GMP-WHO standardfrom Drug Administration of Vietnamin 2010.
Currently Danapha has 21 medicinal products originated from herbs including oils, balm, inhalers and drugs in film-coated tablets and sugar coatedtablets, capsule and syrup ... highly appreciated by consumers at home and abroad in terms of the treatment quality and safety. High quality products are produced on modern production lines in sync from the stage of extracting, condensing, processing, ... to stage of finished products in accordance with GMP-WHO principles.
The quality control plays a very important role in ensuring the quality of medicines. To check the quality of traditional products, Danapha has invested in many modern devices such as microscope with imaging software on the computer, Gas Chromatography Mass Spectrometry (GCMS), High Performance Liquid Chromatography (HPLC), Relatively Standard Liquid Chromatography (RSLC), Infrared Radiation (IR).....And qualified and experienced testing staff is trained to control the quality.
The quality control is performedfrom the input materialsthroughoutand after the extraction process, production of semi-finished and finished products.
Input materials shall comply with standards IV, JP, CP, or basic standards in Viet Nam Pharmaceutical dictionary...
Types of essential oils materials are qualified and quantified on GCMS system with high accuracy. The herbal ingredients are tested according tocriterions such as morphological description, microsurgery, powderendoscopy, microbiology and chemical qualitative reactions, quantitative method by thin layer chromatography TLC, particularly the method of quantifying and marking fingerprintby HPLC-one of existing modern and accurate methods, qualifying the active ingredients or marked substances by HPLC (Currently Danapha has qualified 15-18 the active ingredients in herbs), determiningcontent of heavy metals by AAS, measuring residues of pesticideby GCMS. Especially in the years 2008-2010, Danapha has fully implemented "The Standard Data of herbs commonly used in the manufacturing of Danapha" for 34 medicinal herbs, creating a basic standard for controllinginput materialsserving for production.
Circulating extracting and condensing chain of low pressure enablesto extract and refine various solvents at low temperatures (less than 850C) so that the compositions of extracted plaster of herbs cannot be dissolved at high temperature.
The quality control of extracted substances over the timeaccording to analyseshas determined the solvent, extraction time for each herb, which ensuresextraction and condensing of high efficiency, saves time and fuel materials.
Quality of semi-finished and finished products is checked according to basic standards with specific targets for each manufacturing form and each different type of product. Of which, finished plaster, massage oil, inhalers ... are qualified and quantified by GCMS while the qualification and quantification of other finished herbal products are conductedaccording to TLC method, especially Danapha has extracted and classified some standard herbal substances by Preparative Chromatography Mass Spectrometryand developed qualitative and quantitative processes for such products as“BaiThach”, Cholestin, Phyllanthus according to HPLC method – a highly accurate and fast method.
With modern manufacturing plantmeeting GMP-WHO standard andunder strict quality control thanks to the modern analytical techniques throughout the manufacturing process, Danapha’s medicines ensure good quality in treatment, safety in use, contributing to the improvement of the quality and prestige of traditional medicine of units as well as of the country.