PT  - JOURNAL ARTICLE
AU  - Krause, Stephan O.
TI  - PCMO L01—Setting Specifications for Biological Investigational Medicinal Products
AID  - 10.5731/pdajpst.2015.01065
DP  - 2015 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 569--589
VI  - 69
IP  - 5
4099  - http://journal.pda.org/content/69/5/569.short
4100  - http://journal.pda.org/content/69/5/569.full
SO  - PDA J Pharm Sci Technol2015 Sep 01; 69
AB  - This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages.LAY ABSTRACT: This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system.