Central Admixture Pharmacy Services Inc. (CAPS) Quality Assurance program is designed to ensure Compounded Sterile Preparations(CSP) of the highest quality. Our goal is to provide the most comprehensive and continuous quality assurance program in the industry.
CAPS employs a Quality Assurance (QA) team of chemists, microbiologists, and on-site Quality Assurance personnel.
The CAPS Quality Assurance program provides a framework for integrating measurement, audit, evaluation and improvement systems. These systems are governed by a strict set of standard operating procedures (SOPs) that are supported by didactic learning modules and skill based training.
All CAPS pharmacies admix in a laminar flow, ISO Class 5 zone, within an ISO Class 7 buffer zone. Air testing for particulate and bioburden are performed weekly. Employee fingertip testing is performed weekly. Media fill validation of compounding processes are performed semi-annually. Cleandown and line clearance is performed between every drug, every day. CAPS uses both membrane filtration and rapid sterility testing technology as an end product test per USP<71>. Quality Assurance reports are provided to our customers on a quarterly basis.
CAPS’ policy is to use FDA approved, commercially available, sterile drugs for admixing. In cases where FDA approved sterile drug ingredients are not available, vendor qualification, including regulatory compliance audits, are completed for any Active Pharmaceutical Ingredients (API) used in non-sterile to sterile compounding. All lots of API provided by qualified vendors are tested for chemical identification, impurities, heavy metals, and endotoxin per current USP/NF standards prior to release for use in any CAPS facility.
CAPS high-risk non-sterile to sterile compounding process is validated every six months through a media-fill validation in accordance with USP <797> and FDA Guidance. Each CAPS employee who participates in non-sterile 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 in which they are passed through a 0.2μm pharmaceutical grade sterilizing filter into the final sterile container within an ISO Class 5 Laminar Airflow Work Station (LAFW).
All sterile solutions that are compounded from non-sterile 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. These sterile filtered solutions are quarantined until quality assurance testing, including sterility testing, is complete as required by CAPS Standard Operating Procedures and USP <797>.
Each batch is reviewed by a Registered Pharmacist and the on-site independent Quality Assurance personnel. No lot may be released for use unless all tests performed return results within specifications and the on-site independent Quality Assurance personnel has authorized the batch for release.