title: A practical discussion of risk management for manufacturing of pharmaceutical products.
abstract: Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management is an acceptable and effective way to minimize patient risk and determine the appropriate level of controls in manufacturing. While understanding the elements of QRM is important, knowing how to apply them in the manufacturing environment is essential for effective process performance and control. This article will preview application of QRM in pharmaceutical and biopharmaceutical manufacturing to illustrate how QRM can help the reader achieve that objective. There are several areas of risk that a drug company may encounter in pharmaceutical manufacturing, specifically addressing oral solid and liquid formulations. QRM tools can be used effectively to identify the risks and develop strategy to minimize or control them. Risks are associated throughout the biopharmaceutical manufacturing process-from raw material supply through manufacturing and filling operations to final distribution via a controlled cold chain process. Assessing relevant attributes and risks for biotechnology-derived products is more complicated and challenging for complex pharmaceuticals. This paper discusses key risk factors in biopharmaceutical manufacturing.
  Successful development and commercialization of pharmaceutical products is all about managing risks. If a company was to take zero risk, most likely the path to commercialization would not be commercially viable. On the other hand, if the risk taken was too much, the product is likely to have a suboptimal safety and efficacy profile and thus is unlikely to be a successful product. This article addresses the topic of quality risk management with the key objective of minimizing patient risk while creating an optimal process and product. Various tools are presented to aid implementation of these concepts.
authors.affiliation: Genentech, South San Francisco, CA, USA; amollah@gene.com.
authors.forename: A Hamid
authors.initials: AH
authors.lastname: Mollah
authors.affiliation: ValSource, Jupiter, FL, USA;
authors.forename: Harold S
authors.initials: HS
authors.lastname: Baseman
authors.affiliation: ConcordiaValSource, Wayland, MA, USA; and.
authors.forename: Mike
authors.initials: M
authors.lastname: Long
authors.affiliation: Department of Chemical Engineering, Indian Institute of Technology, Delhi, India.
authors.forename: Anurag S
authors.initials: AS
authors.lastname: Rathore
mesh_terms: D001702:Biopharmaceutics / Q000592:standards*; D003132:Commerce / Q000592:standards*; D003257:Consumer Product Safety; D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry / Q000592:standards*; D004349:Drug Packaging / Q000592:standards; D005079:Excipients / Q000592:standards; D006801:Humans; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D018570:Risk Assessment; D012307:Risk Factors; D013678:Technology, Pharmaceutical / Q000592:standards*
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations