What steps do manufacturers and FDA take to assess the quality of viral vaccines during the production process?
FDA requires vaccine manufacturers to implement certain manufacturing practices to assure the quality of the viral “seed” which is used to generate large amounts of virus needed for vaccine manufacture, the cell culture medium in which the virus will grow, and any components added in the manufacturing process. Vaccine manufacturers must conduct a variety of quality assurance tests throughout the manufacturing process, including tests for vaccine sterility and potency. Samples of each finished vaccine are tested by the manufacturer prior to market release, and FDA may also perform additional testing prior to market release. The specific types of testing required vary from product to product. What FDA regulations and guidance apply to the production of vaccines? The general standards for assuring the quality of vaccines intended to be administered to humans can be found in 21 CFR 610 Vaccine manufacturers are required to implement “current good manufacturing practices,” as described in t
Related Questions
- How does the process for ensuring quality relate to the efforts drug manufacturers take in preventing adulteration or counterfeiting of medicines?
- What steps will FDA take so that manufacturers list accurate serving sizes on food products?
- What steps are involved in the production process for Business Cards?
