We provide solutions and support to hospitals and compounding pharmacies wherever they are in their compliance journey. We offer a wide array of services which can help you streamline your way to meeting NAPRA guidelines.
Services
Compliance Consulting
Audit/Assessment
We provide:
- a gap analysis
- detailed plan for achieving compliance
- Facility design assessment and recommendations (excluding engineering)
- Analysis of insourcing vs. outsourcing
Training
Trained clean room pharmacy staff that exhibit consistent and dependable work practices are the single most important factor in ensuring safe sterile compounding.
We can provide:
- Training Materials for Compounding Personnel
- Hands on training as either “Train the Trainer” or one on one training
- Provide strategies to management that will simplify on boarding of technical staff
- Third party evaluation of compounding personnel
Quality Assurance Program
Quality assurance (QA) in pharmacy compounding is central in achieving the highest levels of patient safety. A QA program is an ongoing, evolving set of activities and responsibilities that reduce the risk of patient harm.
We can provide:
- Standard Operating Procedures (SOPs)necessary to implement the framework of quality management system
- An environmental and personnel monitoring program including sampling plan
- Cleaning program for internal and external users
- Audits of Outsourcing Services (Commercial Compounders, Contractors)
Continuing Support
Compliance is an ongoing activity that requires vigilance and process involvement.
We can provide:
- Periodic Compliance Surveillance that involve quarterly assessment
- Preparation for Compliance Audits
- Assistance in implementation of New Technologies (IV Workflow Software, Robotics, TPN Compounders)