Title 22. STANDARDISATION OF VACCINES AND SERA.pdf ✅

PHARMD GURU Page 1 STANDARDISATION OF VACCINES AND SERA:  Standardization can also be called as quality control of vaccines and sera.  Comparison of test sample assay with the standard is also called as standardization.  Vaccines provide an antigenic stimulus that does not cause disease but can produce long lasting, protective immunity sera containing antibodies. Standardization of vaccines and sera is a critical process to ensure their safety, efficacy, and consistency in protecting against infectious diseases and providing passive immunity. Here's an overview of the standardization process for vaccines and sera: TOXICITY TEST: Preventative and therapeutic vaccines are increasingly used during pregnancy - special considerations are necessary for development of toxicity testing. STERILITY TEST:  It can be defined as the freedom from the presence of viable microorganisms.  Most biological products, including vaccines, administered by the parenteral route are required to be tested for sterility at the final container and also at various stages during manufacture.  The sterility testing as per Code of Federal Regulations and the United States Pharmacopoeia is based on the observation of turbidity in liquid culture media due to growth of potential contaminants. POTENCY TEST:  Combination vaccines differ from single-component vaccines in composition and manufacturing method and also poses significant challenges in implementing effective quality-control tests, including measurement of potency.  Because each combination vaccine is unique, existing guidelines often fail to provide sufficient information to overcome the inevitable problems encountered when developing and implementing potency tests. STANDARDISATION OF VACCINES AND SERA


PHARMD GURU Page 4 SAFETY TESTING: Standardization includes rigorous safety testing to evaluate the potential adverse effects of vaccines and sera. This includes testing for contaminants, such as microbial pathogens, toxins, or residual chemicals, as well as assessing potential allergic reactions or other adverse events associated with the products. REGULATORY COMPLIANCE: Standardization of vaccines and sera must comply with regulatory requirements established by national regulatory agencies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Regulatory authorities set standards for vaccine manufacturing, testing, labeling, and distribution to ensure product quality, safety, and efficacy. Overall, standardization of vaccines and sera is essential to ensure their quality, safety, and effectiveness in preventing infectious diseases and providing immune protection to individuals and populations. It involves a combination of scientific testing, regulatory oversight, and adherence to established standards and guidelines.