Ensure your health-system’s compounded drug products and facilities consistently meet quality standards.
Company Background
ARL Bio Pharma is a contract laboratory that provides analytical and microbiological testing for health-system pharmacies. Since 1998, ARL has supported the industry-wide commitment to deliver high-quality drug products by providing guidance and test services for all phases of the product lifecycle following USP and FDA guidelines. ARL is ISO 17025:2017 accredited, FDA-registered and audited, and DEA licensed for Schedules I through V.
Service Overview
USP standards are critical for health-system pharmacies to produce safe and effective compounded medications. Incorporating these standards into compounding practices promotes patient safety and quality preparations, while minimizing the risk of hazardous exposure.
ARL offers comprehensive testing services for health-systems to quickly and easily meet industry standards.
- Analytical Testing: qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.
- Microbiology Testing: offers the highest quality in USP-required microbiology testing for non-sterile and sterile preparations.
- Personnel and Environmental Monitoring: evaluates plates and media fills for incubation and observation.
- USP 800 Surface Wipe Sampling: measures the level of hazardous drug surface residue to ensure workplace safety.
Beyond Use Dating and Stability Studies
Health-system pharmacies may want to extend a beyond use date (BUD) on a drug product to increase compounding efficiencies and reduce drug waste. USP 795 and 797 require the BUD assignment to be supported by a stability-indicating analytical method.
ARL’s stability indicating methods meet the requirements set by USP and FDA. To ensure that a product retains its quality characteristics throughout its BUD, it is important to also evaluate the physical, chemical, and microbiological properties. ARL has extensive experience in stability studies, and will guide health-systems through the entire process from understanding goals and helping design the study, to providing results and interpreting the data.
Ordering Information
Request A Quote: info@arlok.com
ARL Bio Pharma Client Portal: portal.arlok.com
ARL’s client portal allows users to submit samples online, receive test results in real-time, and analyze test data trends.
ARL Bio Pharma provides analytical and microbiological testing for the pharmaceutical industry. ARL has been serving the clinical and pharmaceutical markets since 1998.
