Quality Assurance & Research
Quality Control & Research Department consists of the following two divisions and mandated to carry out respective responsibilities
Quality Assurance
Quality Assurance is responsible for ensuring consistent Quality, Safety and Efficacy of Products and Services through continuous improvement which is a dynamic process. We focus on establishing and further strengthening of Quality System in the Organization and believe in building quality in the process rather than in testing the quality of end products. Therefore, Quality Assurance program is deployed from the collection of medicinal plants and post harvest care in the fields and the in process control of manufacture of Traditional Medicines and other Herbal products.
Four Quality Control Elements are Raw materials, Packaging materials (labels & printed matters), in process/Intermediate Products, and Finished Products which are controlled to ensure quality of incoming materials and the manufactured products by testing them before being used for manufacture of medicines and marketed them respectively.
Publication of Monograph on Traditional Medicines of Bhutan, Quality Control Handbook on Raw Materials, Quality Manual, Standard Operating Procedures among others are available to be used as references for ensuring consistent and reliable Quality Assurance and Quality Control activities. This division is also responsible for liaising on regulatory matters with the Drug Regulatory Authority of Bhutan.
MSPCL is regulated by the Drug Regulatory Authority of Bhutan for ensuring compliance to Good Manufacturing Practices for manufacture of Traditional Medicines. So far, we have registered 78 Traditional Medicines with the Drug Regulatory Authority and accordingly the manufacturing of Medicines is done as per the Product Registration Dossiers submitted to the Drug Regulatory Authority.
Research Development
Standardization of raw materials and finished products is the core mandates of R & D including new product development, defining process methods and acceptance criteria. Identification of medicinal plants, surveys and mapping of medicinal plants availability across the country for sustainable production of Traditional Medicines is also carried out by this Division among other responsibilities. Recently, four new products were launched namely, soap nut soap, Turmeric soap, Himalayan Goose berry ant wrinkle cream and Rhododendron Hand sanitizer.
Publication of High Altitude Medicinal Plants of Bhutan, Low Altitude Medicinal Plants of Bhutan and Monograph on Medicinal Plants, are available and used for referencing for identification of medicinal plants.
Training is provided to Farmer’s and Community Tshogpa’s involved in sustainable collection of medicinal plants and post harvest care to ensure and maintain consistent quality of materials in collaboration with relevant stakeholders both within and outside MSPCL.
