About & Quality
Our Laboratory and Quality
How Cambria approaches nonsterile compounding: who is responsible, what gets checked, and the standards the program is built around.
Pharmacist oversight
A designated pharmacist leads the compounding program, its procedures and staff training. Every preparation will be checked by a pharmacist before it is released.
Prescription-specific formulation review
Each prescription will be reviewed for patient-specific need, ingredient compatibility, dose, base selection and a supportable beyond-use date.
Ingredient sourcing
Active ingredients and bases will be bought from established compounding suppliers that provide certificates of analysis and documentation.
Documentation
Master formulation records and compounding records will document what was made, from what, by whom and how it was checked.
Quality assurance
The quality system being set up includes written procedures, staff competency assessments, equipment maintenance, cleaning logs and a complaint and adverse event process.
Applicable standards
The program is designed with reference to USP General Chapter <795> for nonsterile compounding, USP <800> where hazardous drugs are handled, and Pennsylvania regulations.
The laboratory
A dedicated nonsterile compounding room, in development.
Being set up inside the pharmacy, separate from dispensing. Equipment details and photographs will be added when the build-out is complete.
Questions
Ask about our process.
Prescribers and veterinarians are welcome to ask about formulation review, sourcing and documentation. To report a quality concern, use Report a Problem.