When the FDA conducts an inspection at your manufacturing facility, will you be ready with the right documentation? In the last couple of years, operators of cyclotrons have been cited for serious deviations from the US Pharmacopoeia (USP) compounding standards and official monograph of Positron Emission Tomography (PET) drugs.
Citations can be and are issued for:
- Failing to establish, document, and perform sterilization activities and appropriate QC tests to assure that the finished drug product is sterile
- Not having procedures or having incorrect procedures
- Not having documentation of facility cleaning
- No record of equipment being certified
- No Training records for operators and technicians
- Incoming materials and supplies not subjected to quality control examination prior to storage and use
- Written procedures not reviewed and updated on a regularly scheduled basis to ensure they reflect correct and current practices
- Not making sure that written production records for each batch are properly maintained
- Failing to conduct and document equipment maintenance as necessary to assure that it operates properly
An FDA Inspection requires all of these things from your facility. BioTrax QMS can help by providing you with a streamlined and paperless approach to managing your facility’s inventory, manufacturing, and delivery needs. With BioTrax QMS, you will be able to accomplish these items in a user-friendly, electronic format, eliminating the need for endless paperwork.
For additional information, to set up a presentation or receive a proposal for the BioTrax QMS, please visit our website at www.ec2Software.com or at 800-851-0025, ext 206.