RT Journal Article
SR Electronic
T1 Points to Consider When Using KPIs/Metrics
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 75
OP 87
DO 10.5731/pdajpst.2020.012401
VO 76
IS 1
A1 Bernhard Hinsch
A1 Sven Alexander Moritz
A1 Ana Esteban Nunez
A1 Timothy E. Orszula
A1 Daniel Taylor
A1 Alexander Nezlin
YR 2022
UL http://journal.pda.org/content/76/1/75.abstract
AB Pharmaceutical quality systems according to ICH Q10 require the identification of processes that need to be measured. Designing and maintaining a metrics system in a way that serves its purpose well requires careful consideration of various aspects in order to meet expectations. The purpose of using key performance indicators/metrics can be defined by main aspects that include: 1) supporting the achievement of objectives by making them measurable, 2) reaching comparability and/or standardization of performance for organizational units, and 3) achieving objectiveness in assessing performance. The first two aspects are closely linked to management responsibilities. Therefore, management needs to be strongly involved with the activities of setting up and maintaining a metrics system. This article provides an overview of the points to be considered when setting up and managing a quality-related metrics system.