title: Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study.
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 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 whether the existing monitoring program met the emerged advanced monitoring practice.LAY ABSTRACT:In pharmaceutical production, cleanrooms are needed for the manufacturing of final dosage forms of drugs-intended for human or veterinary use-in order to protect the patient's weakened body from further infections. Cleanrooms are premises with a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size or number of microorganisms (i.e. microbial count) per surface area. To ensure a low microbial count over time, microorganisms are detected and counted by environmental monitoring methods regularly. It is reasonable to find the easily infected places by risk analysis to make sure the obtained results really represent the state of the whole room. This paper presents a risk analysis method for the optimization of environmental monitoring and verification of the suitability of the method.
authors.affiliation: Validation Department, Dorog Site, Gedeon Richter Plc, Dorog, Hungary; mohazihu@yahoo.com.
authors.forename: Ildikó
authors.initials: I
authors.lastname: Ziegler
authors.affiliation: Microbiological and Hygiene Laboratory, Gedeon Richter Plc, Budapest, Hungary.
authors.forename: Judit
authors.initials: J
authors.lastname: Borbély-Jakab
authors.affiliation: On leave from Quality Assurance Department, Gedeon Richter Plc, Budapest, Hungary; and.
authors.forename: Lilla
authors.initials: L
authors.lastname: Sugó
authors.affiliation: Microbiological and Hygienic Laboratory, Gedeon Richter Plc, Dorog, Hungary.
authors.forename: Réka J
authors.initials: RJ
authors.lastname: Kovács
mesh_terms: D003666:Decontamination; D004340:Drug Contamination / Q000517:prevention & control*; D004780:Environment, Controlled; D004784:Environmental Monitoring / Q000379:methods* / Q000592:standards; D004866:Equipment Contamination / Q000517:prevention & control; D005160:Facility Design and Construction; D006813:Humidity; D008828:Microbiological Techniques / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D018570:Risk Assessment; D012307:Risk Factors; D012308:Risk Management; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D013696:Temperature; D013997:Time Factors
chemical_list: D004364:Pharmaceutical Preparations