August 19, 2021: Pharmaceutical Interview Questions and Answers
#FrequencyOfMediaFill #FactorsToConsiderinMediaFill #DurationOfMediaFillRun #SizeOfMediaFillRun
1. What should be frequency of periodic media fill?
Semi-annual qualification should be conducted for each processing line to evaluate the state of control of the aseptic process.
2. What permutation and combination factors should be covered during the media fill?
Activities and interventions representative of each shift, and shift changeover, should be incorporated into the design of the semi-annual qualification program. E.g. Production shift should address its unique time-related and operational features.
3. What is the requirement of participation of personnel during media fill? What operations need to be done by participants?
All personnel who are authorized to enter the aseptic processing room during manufacturing, including technicians and maintenance personnel, should participate in a media fill at least once a year. Participation should be consistent with the nature of each operator’s duties during routine production.
4. What should be duration of media fill runs?
The duration of aseptic processing operations is a major consideration in media fill design. Although the most accurate simulation model would be the full batch size and duration because it most closely simulates the actual production operations, other appropriate models can be justified. The duration of the media fill run should be determined by the time it takes to incorporate manipulations and interventions, as well as appropriate consideration of the duration of the actual aseptic processing operation. Interventions that commonly occur should be routinely simulated, while those occurring rarely can be simulated periodically.
5. What should be size of media fill runs?
The simulation run sizes should be adequate to mimic commercial production conditions and accurately assess the potential for commercial batch contamination.
The number of units filled during the process simulation should be based on contamination risk for a given process and sufficient to accurately simulate activities that are representative of the manufacturing process. A generally acceptable starting point for run size is in the range of 5,000 to 10,000 units. For operations with production sizes under 5,000, the number of media filled units should at least equal the maximum batch size made on the processing line
Reference: FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice – September 2004
