Quality Assurance Program
Patient Safety—Our Top Priority
The CAPS Quality Assurance (QA) Program helps ensure our compounded sterile preparations (CSPs) are of the highest quality. Our goal is to enforce the most comprehensive QA program in the pharmaceutical industry. To help meet that goal, CAPS employs a QA team of chemists, microbiologists, and on-site quality personnel.
Our QA Program provides a framework for integrating measurements, performing audits and evaluations, and improving systems. The systems are governed by a strict set of standard operating procedures that are supported by learning modules and skill-based training.
All 503A CAPS pharmacies admix in a laminar flow, ISO Class 5 zone, within an ISO Class 7 buffer zone. Clean down and line clearance are performed every day between every drug. Particulate and bioburden air tests, along with employee fingertip tests, are performed on a weekly basis. Media-fill validation of compounding processes is performed semi-annually. Our customers receive QA reports on a quarterly basis.
Highlights of the CAPS QA Program:
- Sterility tests featuring the BacT/ALERT® microbial detection system
- Comprehensive environmental monitoring
- Media-fill validation
- Barcode automation
- Beyond-use-dating (BUD) based on real-time data using stability indicating methods, container closure integrity (CCI) tests, and daily process sterility tests
- Advanced personnel training and education
CAPS only uses FDA-approved, commercially available, sterile drugs for compounding when available. If FDA-approved sterile drug ingredients are not available or do not otherwise exist (e.g. due to FDA recognized drug shortage), vendor qualification—including regulatory compliance audits—are completed for any Active Pharmaceutical Ingredients (API) used in nonsterile to sterile compounding. All lots of API are tested for chemical identification, impurities, heavy metals, and endotoxins per current USP/NF standards prior to use in any CAPS facility.
Our high-risk, nonsterile to sterile compounding process is validated every six months through a media-fill validation in accordance with USP <797> and FDA Guidance. Every CAPS employee who participates in nonsterile to sterile compounding must complete a bi-annual media-fill validation. Once the solutions are prepared from the raw materials, they are sterilized using a cold filtration process. This process passes the solutions through a 0.2µm pharmaceutical grade sterilizing filter into the final sterile container within an ISO Class 5 Laminar Airflow Work Station.
All sterile solutions compounded from nonsterile components undergo validation testing before a CAPS facility may use the solution. All sterility and chemical testing procedures are validated and performed according to current USP/NF standards. The sterile filtered solutions are quarantined until QA testing—including sterility testing—is complete in accordance with CAPS standard operating procedures and USP <797>.
Every batch is reviewed by a registered pharmacist and the on-site, independent QA personnel. No lot is released for use unless all tests return results within specifications and the on-site QA personnel has authorized the batch for release.
QA Tests Performed for Each Batch of Sterile Solution Compounded from Nonsterile Ingredients:
- Mixing vessel/liner integrity tests
- Filter integrity tests (Bubble Point Test)
- Yield verification, label ID verification, and visual appearance tests
- LAL (Endotoxin tests per USP/NF)
- Sterility tests using the Rapid Sterility Method BacT/ALERT® System
- Particulate matter test per current USP/NF HIAC