Each year, millions of medications are custom-made to satisfy the unique requirements of each patient who might not otherwise have access to the proper quantity or concentration of their therapy, or may need an alternate dosage form of a medication.
These compounded drugs are not only unique, but most of them have short beyond use dates (BUDs). These factors paired with changes to United States Pharmacopeia (USP) regulations supporting limiting BUDs even further, make the development of these drugs extremely complex.
In addition to the pressure of getting medications to patients in a safe and timely manner, compounding pharmacies face added layers of QC challenges compared to their traditional counterparts, such as:
• Lengthy sterility and endotoxin testing times leading to extended production cycles, inventory storage issues, and delays in getting drug
products to market within BUD timeframes
• Releasing drug products before results are available from critical QC tests such as sterility and bacterial endotoxin tests leading to
significant risks to patient safety
• Establishing an environmental monitoring (EM) program for the compounding area and implementing a reliable system to track and trend
EM results to demonstrate microbial control of the site
• Lab personnel shortages resulting in increased human error and data integrity issues
During this webinar we’ll address these challenges and provide modern solutions that can elevate your processes and accelerate your compounded drug release to market.
Charles River’s QC microbiology testing portfolio brings you modern products and services that deliver accurate, relevant, and reliable data to allow you to make confident decisions on your product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation.
This post is related to:
USP <795> Non-Sterile Resources, Compliance, Technology
