Stability testing assesses how the quality of a drug substance or Drug product, and it is packaging, varies with time under the influence of environmental factors, such as temperature, light and humidity. The method determines whether any physical, chemical or microbiological changes influence the efficacy and integrity of the end product. This guarantees that a pharmaceutical product is safe and effective, irrespective of where on earth it will be supplied. Stability testing determines that the shelf life and recommended storage requirements of a finished pharmaceutical product and the retest periods for a drug substance.
What Role Does the FDA Play?
The FDA provides recommended guidelines in Accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH, which summarizes the frequency and kinds of conditions which ought to be carried out on any medication entity wanting to apply for FDA approval.A key recommendation is to Perform Stability Testing of the drug substance, which may help identify the possible degradation products, which may then help establish the degradation pathways and the inherent stability of the molecule and also confirm the stability-indicating ability of the analytical procedures used.PCI Synthesis conducts stability study programs based on ICH guidelines Q1A R2 under cGMP for both drug Substance and Drug Product.
How is Stability Testing Conducted?
The most suitable approach to collecting data to determine product Stability and the stability of its packing is to run real-time stability studies. However, since this strategy is time-dependent, forced degradation studies have been conducted to ascertain product stability with time. These studies not only provide vital details regarding the item, but they also determine if the analytical method is a stability-indicating one.Drug Substance and Drug Products are typically studied under at Least two different storage requirements: long-term ambient storage and accelerated conditions. Each stability program is conducted according to an approved protocol, and testing involves the product’s chemical and physical characteristics which might be susceptible to change during its storage, possibly impacting its potency, quality, purity, and finally, security.