Establishment of the Thai Red Cross Plasma Fractionation Centre Supported by the Department of Medical Sciences
6 ต.ค. 2560 0 616
The Department of Medical Sciences (DMSc), Ministry of Public Health, supports the establishment of the Thai Red Cross Plasma Fractionation Centre by providing consulting service and technical assistance to the centre on product quality control. The support brings about the establishment of the centre in the country in accordance with the international standards to support Thai consumers and to reduce the cost of imports.
Dr. Sukhum Karnchanapimai, Director-General of the Department of Medical Sciences, said that “The Department has signed a Memorandum of Understanding (MOU) with the Thai Red Cross Plasma Fractionation Centre, the Thai Food and Drug Administration, the Government Pharmaceutical Organization and the National Health Security Office to promote and support the centre. Moreover, the support leads to capacity enhancement in the production of the product to meet the demand in the country through access to the product and the reduction of imports”.
The DG added that “Plasma contains proteins that play roles in immunity to treat the infections. According to its ability, plasma-derived products are applied for treatments in patients. For the manufacturing of the product, it would have high variations as raw materials are produced from organisms. Therefore, the quality control of production is essential. And also the manufacturer needs to submit the dossier of the product before releasing the product to the market to ensure the quality, safety and efficacy of the product in accordance with the international standards. The Institute of Biological Products (IBP) is responsible for quality control of biological products for registration and lot release. The IBP supports the production of plasma-derived products as part of the MOU. In the past, the IBP provided the training course on “Method Validation for Biological Products” for relevant staff to understand the principle and details of method validation and also the IBP provided the advice and assistance on review of old method validation protocols/reports. As a result, the manufacturer could prepare the quality part of dossier of IMMUNOGLOBULIN 5 TRCS for immunodeficiency and blood platelet disorder treatment as well as FACTOR VIII TRCS for treatment for hemophilia type A”.