PT  - JOURNAL ARTICLE
AU  - Ziegler, Ildikó no
AU  - Borbély-Jakab, Judit no
AU  - Lilla Sugó, Lilla no
AU  - Kovács, Réka J.
TI  - Revision of Viable Environmental Monitoring in a Development Pilot Plant based on Quality Risk Assessment: A Case Study
AID  - 10.5731/pdajpst.2016.007096
DP  - 2017 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2016.007096
4099  - http://journal.pda.org/content/early/2017/01/14/pdajpst.2016.007096.short
4100  - http://journal.pda.org/content/early/2017/01/14/pdajpst.2016.007096.full
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.