Introduction:
Pharmaceutical products shelf-life estimation by assessing through systematic stability study is regulatory requirement, during this review current regulatory requirements elaborated.
The main aim of this study is to produce indication about how the drug substance and drug product quality is changes with time by exposed to different climate conditions like temperature, humidity and photolytic condition. Stability study helps to established retest period for the drug substance and validity of drug product and proposed storage conditions and proves that it meets it’s set specifications.
What is Stability?
Stability defines as, “The formulated products remains stable during it’s period within it’s physical, chemical, microbiological, pharmacological and medicinal specification in its designated packaging state”. Stability study is vital requirement to prove the safety and efficacy of pharmaceutical drug substances and drug products.
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