GMP level release testing

What is Test Hold and Release℠  (THR®) and why is it important?

THR is CAPS' quality assurance program implementing release testing GMP level standards created by the Drug Quality and Security Act (DQSA) for 503B facilities engaged in anticipatory compounding. CAPS embraced these quality controls by developing its own Test, Hold, and Release program to assure that every compounded drug batch from our 503B Outsourcing Facilities meets strict specifications for sterility, endotoxin, and potency release testing. In addition, we perform environment and person testing for every batch. We also offer a Certificate of Release (COR) for each batch.

Our existing high quality standards are further strengthened with THR implementation.  When it comes to patient safety and your reputation, CAPS believes that THR for every batch, every day is the only way to assure the level of quality you require.

 

Does  the FDA require batch level sterility and endotoxin testing in their draft guidance for 503B compounding facilities?

Yes, the FDA requires sterility and endotoxin testing of each batch in 503B facilities.

CAPS is proud to incorporate the strictest of FDA guidelines in our 503B Outsourcing Facilities and will release products only after extensive testing of every batch of CSP's for sterility, potency (based on product need), particulate, and endotoxin testing. It is CAPS' intention to meet the most stringent quality standards and to provide the greatest confidence to our customers. Strict quality control has been the foundation of CAPS for over 25 years and will continue to be so.

Batch level sterility and endotoxin testing are required in FDA's draft guidance for 503B outsourcing facilities. In addition, FDA has issued warning letters for 503B outsourcing facilities who are not meeting these standards.