GMP HS Consulting and Training for Good Manufacturing Practice (GMP) in the field of manufacture of Health supplements (HS) to meet the quality requirements to safeguard public health.
Good Manufacturing Practices shall be implemented in the manufacture of health supplements, such that there is overall control to ensure the consumer receives good quality of product for its intended use. Haphazard operations shall not be permitted in the manufacturing processes of finished products.
Recognising that there are similar GMP guidelines that are in existence and used internationally and by NRAs with international obligation, this document aims to provide guidance for good manufacturing practices. Whilst these guidelines are not intended to place any restraint for the development of new concepts or new technologies, where needed, justifications shall be provided to demonstrate that innovative measures proposed or to be implemented are able to provide equivalent or better controls over the quality system and manufacturing process. Importantly, the safety and quality of health supplements must be assured while using measures other than those described in these guidelines.
The starting materials used in the production of health supplements are often natural in origin. These materials, such as plants and animal parts, are prone to contamination, deterioration and variation in quality. Therefore, the control of the starting materials, storage and processing of health supplements is important. The control is also required because of the often complex and variable nature, the number and the small quantity of defined active materials in many health supplements.
Materials such as animal parts may spread undesirable disease (e.g. Transmissible Spongiform Encephalopathy (TSE), therefore the source of animals, the nature and quantity of animal tissue used in manufacturing, whether there are measures employed in the manufacturing process to inactivate the infectious agents and
ASEAN Guideline on Good Manufacturing Practice for Health
Supplements.
whether there are adequate measures to prevent cross-contamination shall be submitted to the NRA during the product evaluation and registration stage for assessment, when required by NRA. Only materials that have gone through scientific product assessment and subsequently authorized, as deemed necessary by the respective Member State, are allowed to be used for manufacturing of HS.
The manufacture of health supplements depends on the starting materials, manufacturing processes, building, equipment and personnel involved. It is important to recognize that quality control cannot be tested into products; i.e., quality shall be built in by design. All health supplements shall be manufactured under strictly controlled and monitored conditions, and shall not rely solely in finished product testing.
The purpose of these guidelines is to outline steps which shall be taken, as necessary and appropriate, by manufacturers of health supplements with the objective of ensuring that their products are of the intended quality and nature.
Currently, The all Trainer and Auditor of VINTECOM International are fully approved to meet the standards of competence, qualifications and experience, ensuring at least 10 years of quality management experience in the medical field. participating in the implementation of Training, Consulting and Evaluation courses such as: Pasteur Institute Nha Trang - Ministry of Health, National Institute for Accreditation of Vaccines and Medical Biologicals - Ministry of Health, Center for Medical Testing - University University of Medicine and Pharmacy in Ho Chi Minh City, Thong Nhat General Hospital in Dong Nai Province, Bac Ha International General Hospital, Duc Giang General Hospital, Soc Son General Hospital, Bac Thang Long Hospital...
📶📶📶 Contact us to register for GMP HS Training course and Consulting.
Customers, organizations and enterprises require GMP HS Training course and Consulting of the GMP HS (Health supplements), please click on "Registration - Quotation" or on the right toolbar below the PC screen to receive a quotation for training, consulting and certification services.
📶📶📶 Further information, Please contact us as below:
🌐 VINTECOM
International Office in Ha Noi City: 16th Floor - Green Stars City, 234
Pham Van Dong, Bac Tu Liem District, Ha Noi City. Hotline 094-886-5288/ (024) 730-588-58
🌐 VINTECOM International Office in Ho Chi Minh City: D8-09 Rosita Khang Dien, Thu Duc City, Ho Chi Minh City. Hotline 0938-083-998/ (028) 7300-7588
VINTECOM INTERNATIONAL MANAGEMENT CONSULTANCY COMPANY
Head Office: No. 5 Hoang Sam treet, Nghia Do, Cau Giay district, Ha noi City
VINTECOM INTERNATIONAL HN OFFICE
Address: 16th Floor - Green Stars City
234 Pham Van Dong Street, Bac Tu Liem District, Ha noi City
Tel : (024) 730.588.58/ (024) 730.333.86
Hotline: 094 886 5288
Skype: kd.vintecom
Email : office-hn@vintecom.com.vn
Web : www.vintecom.com.vn
VINTECOM INTERNATIONAL HCM OFFICE
Address : D8-09 Rosita Khang Dien
Nguyen Thi Tu, Phu Huu, Thu Đuc City, HCM City
Contact: Ms. Pham Thu Ha
Tel: (028) 7300 7588
Hotline: 0938 083 998
Email : office-hcm@vintecom.com.vn
Web : www.vintecom.com.vn