title: PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.
abstract: 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.
  
  
  
  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.
authors.affiliation: AstraZeneca Biologics, 633 Research Court, Frederick, MD 21703, USA; 301-398-2108; krauses@medimmune.com.
authors.forename: Stephan O
authors.initials: SO
authors.lastname: Krause
mesh_terms: D019985:Benchmarking; D001688:Biological Products / Q000592:standards*; D001702:Biopharmaceutics / Q000592:standards*; D003257:Consumer Product Safety; D015507:Drugs, Investigational / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D061214:Patient Safety; D011786:Quality Control; D018570:Risk Assessment; D012307:Risk Factors; D013678:Technology, Pharmaceutical / Q000592:standards*; D057188:Workflow
chemical_list: D001688:Biological Products; D015507:Drugs, Investigational