Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients

Drug substances and excipients must be stored in recommended storage conditions and should comply with their specifications during the retest period for their use in the manufacture of drug products. The ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for H...

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Bibliographic Details
Published in:	Pharmaceuticals (Basel, Switzerland) Vol. 17; no. 7; p. 903
Main Authors:	Charoo, Naseem A, Akanji, Omotayo, Rahman, Ziyaur, Khan, Aqeel A, Badshah, Aqal
Format:	Journal Article
Language:	English
Published:	Switzerland MDPI AG 07-07-2024
Subjects:	critical material attributes critical quality attributes Humidity Oxidation Particle size Pharmaceuticals retest risk assessment shelf life Tensile strength risk assessment critical quality attributes critical material attributes retest shelf life
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Summary:	Drug substances and excipients must be stored in recommended storage conditions and should comply with their specifications during the retest period for their use in the manufacture of drug products. The ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) and WHO (World Health Organization) regulatory guidelines mandate that after the retest period, the drug substances must be retested for compliance with the specification and then used immediately in the manufacture of the finished product. Although these substances can be retested multiple times, an emphasis is placed on immediate use following a retest and compliance with standards. The phrase "used immediately" is ambiguous and is left for interpretation. In this article, we will look at the various processes that must be completed to determine the retest date. In addition, we present a risk-based method for establishing retest dates and the time during which material can be used.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-Review-3 content type line 23
ISSN:	1424-8247 1424-8247
DOI:	10.3390/ph17070903