- Folder Product Stability and Shelf Life Evaluation
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- Last Updated 27/05/2022
Health Supplement: is the product which is added to the daily diet to maintain, enhance and improve the functions of the human organism. It contains one or a mixture of the following substances:
a. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other biologically active substances.
b. Substances of natural origin, from animal, mineral, and vegetable after process of extraction, isolation, concentration, or metabolism.
c. Artificial synthesized substances from the substances mentioned in (a) and (b) above.
Health supplements are often designed in dosage form (for use) into small dose units such as capsules, tablets, powder, liquid, etc., without sterile preparations (ex. injection solutions or eye drops).
1. Stability/shelf-life studies for health suplements
Stability is a pivotal factor of product quality. Stability is evaluated based on the results from a series of chemical, physical, and microbiological tests. The aim of stability studies is to ensure that product qualify standards during the storage, distribution under recommended conditions.
A stability study should include both physical, chemical, microbiological tests and other properties which are rapidly changeable as well as degradable being likely to affect product quality.
Stability study: is taken under real conditions and accelerated conditions performing for initial batches according to the described protocol to evaluate or confirm a retest date for a material or shelf life of the pharmaceutical product.
Evaluation of the stability/expiry date of health supplement was guided in Circular 18/2019/TT-BYT including the following conditions:
- Accelerated stability: The study designed to accelerate the deterioration or the change the physical properties of a product by storing the sample under extreme conditions. The data from this study, combined with long-term stability data, can be used to assess long-term chemical effects under normal conditions and to evaluate effects over a period in which products are taken out of recommended conditions (ex. In transportation, shipping, etc.). The physical change of the product can not be predicted by the results of accelerated research.
- Stability study under real conditions is a stability study under recommended storage conditions to propose or approve shelf life/retest date for product labeling. For accelerated and real conditions studies, the test frequency should be sufficient to obtain overall stability information. For accelerated studies, there are a minimum of 3 time points, including initial time, and last time, such as at 0, 3, and 6 months for a 6-month study. The frequency of studies in real conditions is usually every 3 months for the first year, every 6 months for the second year, and every year for the remainder of the expected life span.
2. Evaluation of the shelf life of products at the National Institute for Food Control
The National Institute for Food Control can conduct the experiments to determine the shelf life of health supplement under the following conditions:
- Normal conditions: Temperature: 25oC, humidity: 60%
- Accelerated conditions: Temperature: 40oC, humidity: 75%
3. Contact for advice and send samples to evaluate the stability / shelf life of the product
- Head office: Center for scientific and technical services - National Institute for Food Control
Address: 65 Pham Than Duat, Mai Dich, Cau Giay, Hanoi
Hotline: 085 929 9595
Email: nhanmau@nifc.gov.vn/ baogia@nifc.gov.vn
- Representative office in Ho Chi Minh City
Address: Tan Cang - Cat Lai Port, Room A102, Gate B of Cat Lai Port, No. 1295B Nguyen Thi Dinh Street, Cat Lai Ward, District 2, Ho Chi Minh City
Phone: 028.37.400.888/ Hotline: 0918.959.678 (Mr. Nghi)
Email: vpsg.nifc@gmail.com
- Representative office in Hai Phong
Address: No. 1 Ngo Quyen, Hai Phong city
Phone: 0225.8830316/ Hotline: 0983.300.226 (Ms. Thuong)
Email: dothanhthuong226@gmail.com
