USP <797> and <800> Compliance:
USP <797> and <800> have now both been published.
While some facilities do present some daunting challenges where engineering controls are concerned, when properly managed and researched, gaining compliance to these new requirements need not be exceedingly costly or problematic. The ultimate goal of our services is to work with each customer towards this end.
Facility Modification or New Construction
Our approach towards compliance is simple and direct. Each project is begun by conducting an onsite assessment of the pharmacy via meetings with key personnel to determine the types and volumes of compounded product expected to be produced at the facility. Considerations documented at this initial design stage include the future goals of the organization as well as the size, location, and limitations of existing utilities present within the area to be built or upgraded. Placing key pharmacy personnel into the design review process from the first day assures good communication and prevents the end user from being “out of the loop” on their own project. Our project quotes are researched and detailed to eliminate change orders. Change orders routinely increase project cost by 10-20%, and are usually due to unit pricing or a lack of detail during initial reviews.
Validation, Certification and Routine <797> Monitoring
With over thirty years experience in the conduct of culturable industrial microbiological environmental testing and an in-house laboratory both timely and cost effective routine monitoring is assured. Samples are placed into incubation the same day they are collected and shipping expense eliminated. Care is given to ensure that results are useful in managing the contamination control program of the customer, not just becoming a piece of paper filled away because of a standards requirement. When out of specifications results are recovered, a review of historical data is utilized to provide guidance on corrective actions needed to document a return to normal operational conditions.
Procedural Documentation, Training and Consultation
While working towards compliance required by new industry requirements, it is always important to design standard operating procedures which provide the required level of control while being practical to the end user and realistic given the variables present in the operation. We believe that our interdisciplinary experience in the fields of industrial microbiology, contamination control technologies, clean room design and construction, quality assurance and regulatory affairs sets our program above any currently offered. Please feel free to contact us so we can discuss your needs, no matter how small or large.