CAPS Consulting

CAPS Consulting ℠  is a team of pharmacy experts in sterile compounding providing a suite of services for pharmacy cleanrooms.  At CAPS, we perform USP <797>, USP <800>, and 503B outsourcing compliance tests each and every day, year-round, at compounding facilities across the United States. Our consulting team is ready to share this expertise with you.

Ways We Can Help You

Readycheck℠ 797

is an independent, on-site, readiness assessment of your pharmacy’s readiness for USP<797>. Using 200 criteria divided into eight modules, our on-site consultants will observe your process, review your documentation, and inspect your cleanroom. Before we leave, we present our findings in a round-table discussion with key members of your staff and follow up with a robust risk-assessment report that includes a recommended corrective action plan.

Readycheck℠ 800

is an independent, on-site, readiness assessment of your pharmacy’s readiness for USP<800> and a customized plan to help you get there. USP <800> becomes official on December 1, 2019 but more importantly, it is essential for the safety of your employees. Whether you are at the beginning, middle, or completion of your <800> implementation, we can customize Readycheck to help you.

CAPS Consulting also has services to help you implement your own:

  • USP<797> core competency training program for cleanroom personnel
  • Cleanroom environmental monitoring program
  • Cleanroom certification assurance program
  • Cleanroom upgrade project

Let Our Team Help Your Team

We have over 25 years of active pharmacy and clean room experience with expertise in USP <797>, USP <800>, the Drug Quality and Security Act (DQSA), and more. 

 

CAPS Senior Consultant, Eric Bauer RPh, an expert in the compounding field, leads a team of pharmacy experts that can help you reach compliance standards. He has been intimately involved with pharmacy compounding since 1990, and has served CAPS as an IV compounding pharmacist, a Quality Assurance Regional Manager, and a Pharmacy Director.

Eric can work with you and your team to implement an improvement plan that begins with one of our structured Readycheck services designed to lead your pharmacy cleanroom in the right direction.

To support your project, Eric and his team have access to experts in Microbiology, Cleanroom Design, Regulatory Compliance, Process and Equipment Validation, Facility Engineering, Chemistry, and Training throughout the CAPS organization. 

 With real-time experience in operating pharmacy cleanrooms, plus knowledge and confidence acquired from our long history and from our work across the nation, CAPS is your trusted source for sterile compounding expertise.

Please contact Eric Bauer at Eric.Bauer@CAPSpharmacy.com with any questions or inquiries.