PMA is a division of Microbiology Specialists Inc. that specifically addresses compliance issues for sterile compounding pharmacies as described in USP Chapter <797>.
We offer peace of mind to many pharmacies nation wide, performing an extensive list of laboratory services including: microbial testing, sample collection and even consultative services. We know that keeping a pharmacy compliant can be a stressful and daunting task. Therefore, you can count on PMA when it comes to ordering the right media (keeping up with expiration dates and quality control); knowing the most opportune areas to test (expertise in mixed indoor environments); and also understanding the complex rules and regulations of USP <797>. With over 80+ combined years of experience in microbial and environmental testing, PMA offers a comprehensive solution that many pharmacies routinely utilize. We work to simplify the compliance process and make it easy for you to monitor your environment, so you can concentrate on the most important thing, i.e., your patients’ safty and well being.
PMA can help your pharmacy’s compliance needs. The following is a summarized list of vital services which PMA provides to help keep our clients compliant with USP <797> and/or USP <71>.
- Complete environmental monitoring (air, surface and product), random sterility testing and personal competency compliance
- Complete laboratory analysis of your samples and trending of your laboratory results
- Trending of your data on a secure website to evaluate your samples
- Performance of beyond use dating sterility testing for batches
- Performance of media fill and glove tip testing
- Provide and supervise on-site training and testing for any or all of your pharmacy staff in any of the environmental monitoring requirements for USP <797> (facility specific)
Based on our experience, we understand that each pharmacy is unique; therefore we will develop a system that works best with your pharmacy’s exact requirements. We highly recommend that you include us in the development of protocols for your facility’s engineering and environmental services as they pertain to USP <797>. If you have an industrial hygiene and safety engineer and/or an infection preventionist on staff, we would encourage them to participate in any discussions/decisions regarding your facilities engerering and environmental services. This would help to avoid costly duplication and/or omissions in your goals for compliance with USP <797>. Also, if you are considering a new space or renovation, PMA has experienced personnel to help with the design, workflow and progress towards compliance with USP <797>. This would also include any satilite pharmacy or lab services.
Please contact us for consultation and pricing.