ASEAN Guideline on Stability Study of Drug Product

 ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT

Stability testing is integral to developing new pharmaceutical products and active pharmaceutical ingredients, to establish their shelf life or expiry date. It is also equally important along with ongoing routine manufacturing to monitor product quality as a function of time. We provide a complete solution to your requirements of Stability Studies for Shelf-Life Estimation during

Product Development

Product Shelf life evaluation

Packing Material development & change over

For Product Registration in Global Markets

Critical supplier change

This guideline is intended to provide recommendations on the core stability study package required for drug products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the products being evaluated. This guideline can also be used to propose shelf life based on the stability data generated from the study package.

This guideline addresses the information to be submitted during application for marketing authorization/registration and variations of drug products in ASEAN Member States including examples of a protocol of stability study, a report format, reduced design and extrapolation of data, and examples of types, thickness and permeability coefficient which are covered in Annexes.

ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT