What are the quality specifications that drug makers need to follow
1 min read . Updated: 23 Dec 2021, 12:15 AM IST
PremiumThey must test if the drug contains the compound it claims to have, and the right amount of it. Other tests include an inspection of the clarity of the liquid, and a test to ensure that drug impurities are within limits
To ensure that injectable drugs are safe and effective, manufacturers are required to conduct a number of tests before selling them. They must test if the drug contains the compound it claims to have, and the right amount of it. Other tests include an inspection of the clarity of the liquid, and a test to ensure that drug impurities are within limits. Together, these tests are called ‘quality specifications’.
Two of the most important specifications for injectable drugs are that they should be sterile and have limited amounts of bacterial endotoxin. Sterile means that the drug has no live microbes, while endotoxins are toxins released by these microbes.
Endotoxins released by gram-negative bacteria are especially dangerous to humans, because they can cause septic shock and kill patients. This is a particularly worrying problem for injectables because these drugs enter the bloodstream directly, bypassing the gastric system. The gastric system has evolved some mechanisms to fight these contaminants off. But when microbes and toxins enter the bloodstream, where fewer such barriers exist, the contaminants can quickly turn deadly.
For this reason, texts called Pharmacopoeias, which mandate quality standards for all drugs sold in a particular country, must have sterility and bacterial endotoxin tests for all injectables
