The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human usage was founded in 1990 as a means to standardize the introduction of new drug substances into the global industry. The council wrote and maintains guidelines for how new pharmaceutical products must be tested for quality and stability before they may be eligible for worldwide distribution. The guidelines shield consumers and permit new therapeutic drugs to reach patients across international borders more quickly. The ICH has written guidelines for its stability testing of new drug substances and products. There is a general document called Q1AR2 that summarizes the specifics of every stability test a new drug substance must undergo before being enrolled. These tests examine the way the medication dissipates in high temperature or high humidity with time. It outlines methods for defining the mechanism of degradation to the new drug, and the best way to test suggested protective packaging for efficacy. A supplementary document Q1B contains additional details especially about photostability testing.
The First aim of the Stability Testing is to do a stress test to be able to define the degradation products of the new drug substance and to comprehend and clearly record the pathways of decomposition. The intention of the stress test would be to fully understand the dangers involved with the medication. It can be a wonder drug from the lab, but if it is not stored, transported, and utilized correctly then it may decompose into a totally different molecule with possibly devastating side effects.The Medications are evaluated by proper compound, biological, and microbiological methods. Any changes in colour, consistency, stage, pH, dissolution time, dose effectiveness, or any other specification is noted from the first stress test.
Packaging is then designed to mitigate these modifications and the packed drug is tested again in the packing and suggested storage conditions room temperature, refrigerator, freezer, and relative humidity. If the drug passes its specifications with the packaging then it moves on the longer-term storage stage of the stability test. The long term storage test is a minimum of 12 weeks. The medication must match the first tests to within 5 percent so as to be enrolled for international sale. All of equilibrium test information must accompany the medication to the marketplace.