Abstract
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.
- Received July 19, 2016.
- Accepted January 10, 2017.
- Copyright © 2017, Parenteral Drug Association
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