What manufacturing requirements must be satisfied by domestic manufacturers of health supplements in Vietnam?

Pursuant to Clause 1 Article 3 of the Circular 18/2019/TT-BYT, domestic manufacturers of health supplements shall satisfy food safety conditions specified in Clause 1 Article 28 of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety and the following principles and requirements of GMP for health supplements :

- Health supplements are manufactured in such a way that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. To achieve the quality objective reliably, there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. It should be fully documented and its effectiveness monitored. All parts of the quality assurance system should be adequately staffed with competent personnel, and should have suitable and sufficient premises, equipment, and facilities;

- Every manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience relevant to their assigned function. Staff at all levels should receive initial training and periodic training in GMP principles and for the tasks and responsibilities assigned to them;

- Premises and manufacturing equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and in general, any adverse effect on the quality of products;

- A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of health supplements. The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, products for cleaning and disinfection, and anything that could become a source of contamination to the product;

- Every manufacturer should establish a system of clearly written documentation that consists of procedures, standards, manufacturing formulae, processing and packaging instructions, is able to record executed activities for manufacturing, quality control, distribution and other matters linked to GMP, and permits tracing of batch history of the product, from receiving of starting materials to the distribution of finished products.

- There must be an authorized manufacturing process existing for each product, including detailed regulations on manufacturing and quality control, with the objective of obtaining a product of the requisite quality, consistent with the approved specifications. Executed activities for each batch should be sufficiently and clearly documented and retained as prescribed;

- Every manufacturer should have a quality control system so designed as to ensure that the production and the quality control departments are independent of each other and that the products are manufactured in accordance with adequate conditions and procedures and continue to meet the established specifications;

- If a product is manufactured and/or analyzed under a contract, the contract manufacture and/or analysis must be correctly defined, agreed and controlled. The contract must clearly establish the duties and responsibilities of each party and clearly state the way in which the authorized person releasing each batch of product for sale exercises his full responsibility.

- All complaints and other information concerning potentially defective products must be kept and reviewed according to written procedures. A system shall be designed to recall promptly and effectively products known or suspected to be defective from the market.

- Self-inspections shall be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.

- Detailed contents of GMP for health supplements are provide in the Appendix hereof.

Best regards!