GMP - Good Manufacturing Practice application
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Since establishment in May 2004 until now, KIS Science & Technology Consultant Co.;Ltd is always leading in the field of Consultanting for quality management system application according to current international standards, including consulting for GMP - Good Manufacturing Practice application.
GMP covers general principles, rules, guidelines and basic contents of production conditions issued by World Health Organization (WHO) to be applied on establishment in production, processing, food packaging, pharmaceuticals, medical equipments and cosmetics.
The GMP regulations specify a quality approach to manufacturer and help enterprises to eliminate or minimize pollutants and risks involved in production and business activities. This also contributes to ensure that consumers are not affected or even periled their life.
GMP concerns about important factor such as human, materials, equipments and the environment at manufacturing sites, including solving complaints and recalling wrong products. The requirements of GMP are extensive and scalable, allowing manufacturer to decide on the number of regulations, standards, procedures and work instructions so as to meet the necessary requirements and compliant with the production field and infrastructure conditions of the enterprise. Therefore, the number of regulations/procedures of GMP system for each enterprise will be different.
The legal basis for the application of GMP in Vietnam
In 1997, the Directorate for Standards, Metrology and Quality issued Decision No 05/1997 / TDC General guidance on the basic content of GMP to apply in food production facilities.
In 2004, the Ministry of Health issued Decision No 3886/2004 / QD-BYT dated 03rd October 2004 regarding applying principles and standards of "Good Pharmaceuticals Manufacturing Practice" as recommended by the World Health Organization. The decision required all pharmaceutical production facilities must be certified by GMP-ASEAN by the end of 2006, and all topical and herbal medicines manufacturing enterprises must be certified by GMP-WHO by the end of 2010.
In 2004, Minystry of Agriculture & Rural Development issued Decision No. 08/2004 / QD-BNN-TY dated 30th March 2004 has specified for applying the principles and standards of "Good Veterinary Medicine manufacturing Practice".
In 2007, the Prime Minister issued Directive No 06/2007 / CT-TTg on the Implementation of urgent measures to ensure food safety, which requires application of GMP, GHP, HACCP in food production, food safety and hygiene management.
In 2008, the Health Ministry issued Decision No. 5/2008 / QD-BYT has specified that traditional chinese medicine manufacturers must apply the standards of Good Manufacturing Practice GMP as other pharmaceutical manufacturers.
On 4th November 2013, the Ministry of Health issued a consolidated text No 04 / QDHN-BYT 2013. Consolidated Decision applying the principles and standards of "Good Manufacturing Practice" as recommended by the WTO - was issued by the Ministry of Health.
The significance and benefits of applying GMP
All important processes are reviewed, developed, approved and implemented in order to ensure stability and compliance with the specification;
The conditions for the production process are identified and given requirements to be implemented clearly;
Lower costs due to the standardized manufacturing process and quality control, minimum requirements for workshops and equipments is clearly defined for good investing (There is no excessive or improper investment) ;
Improve mobility, responsibility and understanding the work of staffs, enhance confidence of customers and management bodies;
Gain international recognition and protection of the product trademark, increase competitiveness and marketing, business opportunities, export of food;
Transfer from independent testing to recognition, each other acknowledge, meet integration process and requirements of the import market.
CONTACT / SUPPORT
KIS has full competence to assist enterprises in production, processing, food packaging, pharmaceuticals, medical devices in the planning, design, construction and installation that guaranteed technical conditions and management under GMP.
Please contact us for assistance via email: vphn@kis.vn or via hotline: 0942.99.66.88 for details.
The GMP regulations specify a quality approach to manufacturer and help enterprises to eliminate or minimize pollutants and risks involved in production and business activities. This also contributes to ensure that consumers are not affected or even periled their life.
GMP concerns about important factor such as human, materials, equipments and the environment at manufacturing sites, including solving complaints and recalling wrong products. The requirements of GMP are extensive and scalable, allowing manufacturer to decide on the number of regulations, standards, procedures and work instructions so as to meet the necessary requirements and compliant with the production field and infrastructure conditions of the enterprise. Therefore, the number of regulations/procedures of GMP system for each enterprise will be different.
The legal basis for the application of GMP in Vietnam
In 1997, the Directorate for Standards, Metrology and Quality issued Decision No 05/1997 / TDC General guidance on the basic content of GMP to apply in food production facilities.
In 2004, the Ministry of Health issued Decision No 3886/2004 / QD-BYT dated 03rd October 2004 regarding applying principles and standards of "Good Pharmaceuticals Manufacturing Practice" as recommended by the World Health Organization. The decision required all pharmaceutical production facilities must be certified by GMP-ASEAN by the end of 2006, and all topical and herbal medicines manufacturing enterprises must be certified by GMP-WHO by the end of 2010.
In 2004, Minystry of Agriculture & Rural Development issued Decision No. 08/2004 / QD-BNN-TY dated 30th March 2004 has specified for applying the principles and standards of "Good Veterinary Medicine manufacturing Practice".
In 2007, the Prime Minister issued Directive No 06/2007 / CT-TTg on the Implementation of urgent measures to ensure food safety, which requires application of GMP, GHP, HACCP in food production, food safety and hygiene management.
In 2008, the Health Ministry issued Decision No. 5/2008 / QD-BYT has specified that traditional chinese medicine manufacturers must apply the standards of Good Manufacturing Practice GMP as other pharmaceutical manufacturers.
On 4th November 2013, the Ministry of Health issued a consolidated text No 04 / QDHN-BYT 2013. Consolidated Decision applying the principles and standards of "Good Manufacturing Practice" as recommended by the WTO - was issued by the Ministry of Health.
The significance and benefits of applying GMP
All important processes are reviewed, developed, approved and implemented in order to ensure stability and compliance with the specification;
The conditions for the production process are identified and given requirements to be implemented clearly;
Lower costs due to the standardized manufacturing process and quality control, minimum requirements for workshops and equipments is clearly defined for good investing (There is no excessive or improper investment) ;
Improve mobility, responsibility and understanding the work of staffs, enhance confidence of customers and management bodies;
Gain international recognition and protection of the product trademark, increase competitiveness and marketing, business opportunities, export of food;
Transfer from independent testing to recognition, each other acknowledge, meet integration process and requirements of the import market.
CONTACT / SUPPORT
KIS has full competence to assist enterprises in production, processing, food packaging, pharmaceuticals, medical devices in the planning, design, construction and installation that guaranteed technical conditions and management under GMP.
Please contact us for assistance via email: vphn@kis.vn or via hotline: 0942.99.66.88 for details.