Test Hold and Release (THR) is the new GMP level standard created by the Drug Quality and Security Act (DQSA) for 503B facilities engaged in anticipatory compounding (compounding product batches without a prescription).
THR is a quality assurance program we embrace for every batch assuring you that every compounded drug batch from CAPS® will meet specifications for sterility, endotoxin and potency tests prior to release.
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Does the FDA require batch level sterility and endotoxin testing in their draft guidance for 503B compounding facilities?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 20 years and will continue to be so.
Batch level sterility and endotoxin testing are required in FDA's draft guidance for 503B (http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-0779-0002) outsourcing facilities. In addition, FDA has issued warning letters for 503B outsourcing facilities who are not meeting these standards.