By Andrea Kühn-Hebecker

Published in: GMP Journal, issue N° 34, page 4 (2022)

Published on: April 28, 2022

Introduction: Stability is defined as the extent to which a product retains, within specified limits, the same properties and characteristics that it possessed at the time of its manufacture and release throughout its period of storage and use (i.e., its shelf-life). All specification limits thus apply during stability studies and during the whole shelf life of the drug product until the end of the labeled expiry date (APIs: re-test period / retest date). Every pharmaceutical product on the market shall be so constituted that, if stored as directed, it will meet all applicable pharmacopoeial requirements and manufacturer's specifications until its expiration date. But which parameters need to be tested for medical cannabis during stability studies? And which requirements apply? Useful information in relation to these questions is provided in the following sections.

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