ResultsWhile of necessity all these case studies are anonymous, recommendations are available on LinkedIn.com at http://www.linkedin.com/in/scottvwsutton. ConsultingProcess Change Results in Reduced Unit Production CostsCompany X presented a process that had been developed in the 1960s that used a highly contaminated material as the initial raw material. This raw material (and its large microbial load) was then pooled and treated with a toxic antimicrobial to reduce the bioburden before processing. The project involved developing a regulatory strategy to allow reduction or removal of the toxic compound from the approved process as disposal costs for the spent material was a significant component of the unit cost. Our Solution: We worked with corporate Regulatory Affairs on the strategy, and then collected the requisite data (this required a year's worth of data by internal expectations). The actual project required management of project tasks, evaluation of the microbiological data - both bioburden and identification, and design/review of laboratory scale models against the manufacturing process. An alternate method was qualified using temperature rather than chemicals to maintain bioburden control which resulted in significant reduction in unit production cost. This process change was approved by the relevant national regulatory agency and is currently implemented. Technicians Trained In Preparation for (Successful) Regulatory AuditCompany X, located in Europe, was concerned about preparation for an regulatory audit. In preparation for this visit they supplied procedures and validation studies which allowed preparation prior to the on-site visit. Our Solution: During the on-site audit there was opportunity to train technicians in audit protocol as well as to identify several areas of potential improvement for the QC microbiology lab, the sanitization and Environmental Monitoring program, and the manufacturing operators. The facility passed its audit. Lab Redesign and Procedure Revision Produces Dependable DataCompany X was building an aseptic manufacturing facility and was having a great deal of trouble with the microbiology laboratory and the testing performed in support of the aseptic EM program. Our Solution: Upon review, there were several procedural issues that required attention in the lab. This developed to the point where the lab was redesigned to provide greater separation of clean and dirty operations and several validation studies that were questionable. After purchase of more appropriate lab equipment in some cases, revision of procedures and retraining in others, persistent "bioburden" issues were resolved and the lab began functioning efficiently, providing dependable data. This allowed identification of several true problems in the aseptic facility which were eventually corrected resulting in the successful qualification of the facility for aseptic production. Training3-Day GMP Training with a Focus on Contamination ControlCompany X brought us in as part of a facility qualification project, but needed training on GMP with a focus on contamination control. Our Solution: In working with Manufacturing/Operations, Regulatory Affairs and Quality Assurance we developed a three-day GMP course that was conducted over a three week period to great success. Successful ½ Day GMP Training Course Turns into Annual Program for Several LabsCompany X was a contract testing laboratory who needed annual GMP training to fulfill GMP requirements. Our Solution: In working with the company we developed a half-day course based on 483 observations and warning letters to underscore the different aspects of the microbiology lab GMP requirements. The course was successful, and the next year it focused on lab audit criteria with the following year focusing on specific considerations in 21 CFR 211 of interest to the microbiology lab. This annual training program is now a popular one for several labs “Intro to Microbiology” Course Developed for Company Working in Pharmaceutical DevelopmentCompany X had no microbiology but needed background in their role as a CRO specializing in clinical studies for pharma development. Our Solution: To this end we developed a three-day course on "Introductory Microbiology for the Pharmaceutical Industry" that was extremely well received. Starting from the basic science, we moved through compendial requirements, manufacturing contamination control and environmental monitoring through investigations and problem solving/risk analysis over the three week period. |
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