The expiry date printed on your medicines isn’t arbitrary—it’s carefully determined through rigorous stability studies to ensure the drug remains safe and effective throughout its shelf life. Here’s a breakdown of how it’s done: ---Step 1: Stability Studies Pharmaceutical companies test drugs under controlled conditions to monitor:Potency: The active ingredient should remain within 90–110% of … Continue reading How Expiry dates are determined for Medicines
Tag: health
How to respond to 483 observation & Warning Letters?
As a recipient of a response warning letter, it is important to follow the basic steps outlined below to ensure a timely and effective response. 1) Acknowledge receipt of the letter through certified mail, informing the FDA that we intend to respond within 15 business days. This initial correspondence should be brief, simply and serve … Continue reading How to respond to 483 observation & Warning Letters?
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