SHELF LIFE EXTENSION PROGRAM: REVALIDATING THE EXPIRY DATE

2016-12-16 2016-12-21 2016-12-25 9/29/2024 5:17:27 AM Journal of Applied Pharmacy 8 2016 Editorial 69 70 2016 JAppPharm-8-69 http://dx.doi.org/10.21065/19204159.8.69 English Kamla Pathak Shelf life, Extension program, Revalidation. From a Pharmacist’s viewpoint expiry date is the time required for the drug content of a formulation to reduce to 90% of its labelled amount. Generally speaking, expiry date can be viewed as a guarantee from the manufacturer that drug formulation will maintain its potency within the specified period, in the storage condition recommended by them. The guarantee is conditional in as much as a drug formulation will maintain its potency within the period (Expiry date) if there has been no deviation from the recommended storage condition. The manufacturer’s guaranteed life period of the products are disclosed to the consumers by printing the expiry date on the label1