RT Journal Article
SR Electronic
T1 Revision of Viable Environmental Monitoring in a Development Pilot Plant based on Quality Risk Assessment: A Case Study
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2016.007096
DO 10.5731/pdajpst.2016.007096
A1 Ziegler, Ildikó no
A1 Borbély-Jakab, Judit no
A1 Lilla Sugó, Lilla no
A1 Kovács, Réka J.
YR 2017
UL http://journal.pda.org/content/early/2017/01/14/pdajpst.2016.007096.abstract
AB In this case study, the principles of Quality Risk Management were applied to review sampling points and monitoring frequencies in the Hormonal Tableting unit of a Formulation Development Pilot Plant. In the cleanroom area premises of different functions are located, therefore a general method was established for the risk evaluation based on the Hazard Analysis and Critical Control Points (HACCP) method to evaluate these premises (i.e. production area itself and ancillary clean areas) from the point of view of microbial load and state in order to observe if the existing monitoring program met the emerged advanced monitoring practice.