GMP consultants for pharmaceutical manufacturing companies in Vietnam

Apply GMP key point

The WTO for pharmaceutical manufacturing companies the Ministry of Health has been extended from 12/2006 to 7 / 2008. However, until now many companies still are required to properly implement the roadmap. We had a meeting with Dr. Truong Quoc Cuong - Director of Department of Pharmacy Administration, Ministry of Health around the issue.- Sir, the economic situation also encountered some difficulties at present, plus difficulties in land clearance, land funds, the financial mechanism ... of enterprises producing medicine, material term pressure response GMP - WHO has been "back" no more?Leaders of the Ministry of Health decided not to extend additional route application for WHO-GMP production facilities medicine. However, to ensure the maintenance and production activities, business operation and in particular to avoid affecting the supply and demand situation in the pharmaceutical current phase, Pharmacy Administration is proposing to leaders of enterprises continue production under specific guidelines: In the current phase, to the basis change from time to GMP-ASEAN GMP-WHO, the Ministry of Health agreed to continue the company to maintain production on facility maintenance principles and standards GMP-ASEAN.For companies not meet GMP is building factories in GMP-WHO: The facility will allow continued production outsourcing by the method of medicine SDK also on the production line GMP-WHO .Ministry of Health will inspect and closely monitor the production activities of enterprises to implement and to ensure compliance with the above principles of the Health Ministry.- So to this point how many companies still have not applied GMP-WHO, sir?Up to the moment, apart from 67/93 production facilities medicine has achieved GMP-WHO, it has six facilities GMP-ASEAN applicants registered GMP-WHO awaiting inspection facilities GMP-8 ASEAN is converted to GMP-WHO; only 12 facilities and has committed to complete construction of the plant GMP-WHO in late 2008 early 2009.If the time limit mentioned above if the facility does not meet GMP-WHO in accordance with the roadmap will have to change the form of drug production. For example, in drug processing facilities meet GMP ...- Sir, when switching to production line GMP-WHO, the drug lots remaining deposits were produced on the old line companies will be treated like?Under the provisions of the Government, producing tobacco goods business conditions, so in order to produce the drug facilities must meet the conditions stipulated by the Ministry of Health of production facilities and test quality from raw material to finished product in the output. This means that the drug produced on the old line has met conditions stipulated by the Ministry of Health and quality control meet the requirements shall still be used. However, the needs of drug users require quality and increasing efficiency. To meet requirements for export to international markets the drug, the Health Ministry issued regulations on the application of principles of GMP-WHO standards for enterprises to upgrade the factory, investment machinery manufacturing, research technical innovations to ensure the drug dosage drug manufactured quality and effectiveness of treatment as desired by the user, and on par with other countries in the region and the world.- Thank you.
 GMP-WHO means practicing good medicine production standard of the World Health Organization. Prescribed to achieve the principles and standards of GMP-WHO, every pharmaceutical manufacturing company to achieve these requirements: Quality assurance; Good Manufacturing Practice; sanitation and hygiene conditions ; Self-inspection and quality inspection; requirements workshops, equipment, materials, records and documents, especially own practices of testing quality.Accordance with the functional bodies, good manufacturing practice medicine as part of quality assurance, help ensure that products are manufactured to a consistent and controlled strictly according to quality standards consistent with the purpose of use. The principles of good drug manufacturing practice first in order to navigate to remove the risk occurs in manufacturing pharmaceuticals. The risk is divided into two types: cross-infection and confused. So make good drug manufacturing practice requires that all manufacturing processes are clearly defined, is reviewing a system experience and proven ability to produce enough of the product products meet the requirements of quality standards given ...

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