Quality Control

The comprehensive quality control laboratory of Vira Vaccine Shaya company was launched in September 2017 with the use of professional experts. The inauguration purpose of this laboratory is the analysis of materials before consumption at the production site, controls during production and quality approval of the product. The quality control laboratory consists of molecular, microbial, cellular, serology, control during production, animal lab, small and large livestock farm. The quality control laboratory, initially takes samples from the shipment upon the arrival of the raw materials and before using any type of material in the production of the product, based on valid sampling instructions, and tests the raw materials in accordance with valid references, including USP and EP and if the material is approved, it issues a license to use it on the production site. In the next stage and with the start of production, the quality control laboratory controls all stages of product production and evaluates the performance of individuals and materials. The beginning and end of each stage is controlled by experts and permission to enter the next stage of production is issued. Evaluation of the sterility of consumable materials and equipment, the virus used in vaccine production, the performance of production personnel, monitoring of Laf and air conditioners of the production site, consumable packaging items and control of the correct operation of devices, including filling and lyophilization devices, are among the duties of quality control experts. Also, after the production of the final product, the quality control laboratory performs all the required analyzes on the final product in accordance with the world’s most reliable references, including OIE. Conducting stability tests is one of the other activities of the quality control laboratory. These tests are performed on at least three batches of each product and continue for one year after the expiration date of the product. The quality control laboratory is responsible for checking the evaluable parameters of new products based on reliable sources or the analysis method received from the research and development unit on the first part of laboratory production as well as the first part of industrial production and reporting the results to the relevant units. Also, harmless tests are performed in animal lab of quality control laboratory of Vira Vaccine Shaya company. The location of this animal lab is designed in such a way that it can be controlled in terms of temperature and humidity so that you can have proper control over the laboratory animals and also create conditions that the health status of the animals can be checked during monitoring. The conditions of keeping animals in the farm of Vira Vaccine Shaya company are such that the animals are kept separately in isolated boxes. This way of storage minimizes the possibility of foreign agent or microorganism entering inside the boxes, as well as the possibility of virus or pathogenic agent escaping, so conditions are created that provide the possibility of any clinical test, including challenge with pathogenic virus. The animals are examined daily and their clinical conditions are recorded during monitoring. The presence of professional and trained staff, is one of the strong points of the quality control laboratory of Vira Vaccine Shaya company, which thus enables this unit to perform all tests based on the latest edition of valid veterinary and pharmaceutical authorities’ references.