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# FDA Self-Audit Sees Continuous Manufacturing Advantages
- URL: https://www.fdaweb.com/fda-self-audit-sees-continuous-manufacturing-advantages/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152236

A CDER Office of Pharmaceutical Quality (OPQ) self-audit comparing approved drug regulatory submissions that employ continuous manufacturing versus traditional batch processes has identified regulatory and patient advantages to continuous manufacturing. In a CDER [podcast](https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-self-audit-continuous-manufacturing-drug-products?utm%5Fmedium=email&utm%5Fsource=govdelivery), OPQ deputy director **Mahesh Ramanadham** says the audit found that applications that used continuous manufacturing were approved in a shorter time than the comparator batch applications. They were approved ahead of the PDUFA goal date on average nine months faster than the traditional applications, he says. And they made it to market 12 months faster on average after regulatory submission and three months faster after approval.

Ramanadham says all continuous manufacturing applicants in the audit engaged with CDER’s Emerging Technology Program and that may have helped support their first-cycle approvals.

After listing other advantages the audit found, Ramanadham says FDA encourages the use of continuous manufacturing for the development and manufacturing of drug substances and finished drugs.

“Overall, the findings of this self-audit do not indicate higher regulatory risks to submissions or outcomes for continuous manufacturing applications when compared to batch applications,” he concludes. “In fact, there are potential regulatory advantages for applications using continuous manufacturing such as manufacturing process scale-up flexibility, improved manufacturing agility, you name it. In addition, we saw a clear economic advantage for sponsors and manufacturers translated through the time to approval, time to market, and early revenue benefit. The implementation of continuous manufacturing is also advantageous for patients, not only because of early access to medicines, but also due to the potential to reduce or mitigate drug shortages and increase product availability.