Pharmacy Compliance Services
- Do you need help to become compliant with USP Chapter <795> and <797> regulations?
- Do you need help with becoming PCAB®-accredited?
If you answered “yes” to either of the above questions, then you need the assistance of PCCA’s Pharmacy Compliance Team!
A PCCA Pharmacy Compliance Specialist will conduct an audit of your facility and equipment to determine its compliance with USP <797> and <795>. This assessment is a survey/checklist of systems and documents that should be in use at your facility according to industry regulations. Items on the checklist that are not observed at your facility are considered “gaps” that need to be addressed and corrected in order to ensure your facility, equipment and personnel are compliant with the requirements of <797> and <795>.
During this one- to two-day analysis of your facility, your PCCA Compliance Specialist will review your:
- Documentation system
- Training records
- Process controls
- Environmental monitoring
- Aseptic process and technique
- Finished preparations testing
- Quality assurance program
After this review and observation period, your PCCA Compliance Specialist will spend a half-day generating a final report of conclusions and findings. This report will demonstrate your company’s strengths, as well as areas that require improvement. The observations can be transferred into a task list of items that need to be implemented. At this point, it’s up to you as to how to proceed next! You can choose to make the corrections noted in the report yourself, or you can enlist PCCA’s Implementation Services to perform all of the report recommendations.
Your PCCA Specialist will spend time at your facility, working with you to improve the quality of your facility and processes to ensure your compliance with USP <797> and <795>. Your Specialist will work with you to achieve your compliance goals in a cost-effective and timely manner.
PCCA assistance includes:
- Complete development of your customized Standard Operating Procedure Manual
- Complete set-up of your environmental monitoring process
- Training of your staff regarding proper gowning and gloving techniques