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In over 75% of cases there has been some observation or suggestion that has been taken on board by the facility at the end of a CCA. The average CCA takes approximately 2 hours to complete – a small commitment with potentially significant results. Typical results include the identification of cost saving opportunities, solution to identified problems, recommendations for improved cleaning and disinfecting SOP and training suggestions.
Conducted by our Technical Services Group of experts, there is no “one size fits all” approach to a Contamination Control Assessment as every end user and facility is different. The CCA can be tailored to the unique needs of the assessment site. Each CCA follows the same format of Plan, Observe and Report.
Together we will plan to determine the specific cleaning and disinfection protocols, procedures and tools that we are going to evaluate in your facility. The team will then observe and speak with personnel in operations, QA, production, engineering etc. to identify potential process or procedural improvements.
At the end of the process you will receive a written report which will include a summary of our observations and specific recommendations for improvement, where necessary, including suggestions for the use of specific tools or equipment.
By observing operations and cleanroom behaviours, Contec provides recommendations as to product suitability, contamination control protocols, best practices, and cost-saving opportunities. CCAs are a value-added service, consultative in nature and provided at no cost to the end user/customer.
Remote assessment with stationary or touring video observation with one of more TSG experts.
A complete and thorough onsite assessment with one TSG expert.
The new GMP regulations coming out of the European Union will have a big impact on pharmaceutical manufacturers. How will it affect cleaning and disinfection protocols?
