Interpreting Regulations and Meeting FDA Requirements at CPHI North America

At CPHI North America in May 2024, Pharmaceutical Technology® sat down with Purna Thakker, founder and CEO of ADPT Solution, to discuss common issues that companies face when following FDA regulations. Thakker went over the rising trends in FDA 483s during the past few years, how to interpret older regulatory documents with modern terminology, and how companies can reduce the potential for non-conformance.

When asked how companies can reduce the potential for non-conformance, Thakker said, “There are CAPA [corrective and preventive action] procedures written by every company. And FDA does recommend in their guidance documents [from 2006] about CAPA [that] they do expect companies to do preventive action. However, there are no regulations written about preventive action. So, the non-conformities written in [Code of Federal Regulations] 820.100 for CAPA is very different than CGMP [Current Good Manufacturing Practice] 211.192. The thorough investigation is written very specific to CGMP, and that is [ missing in] CAPA procedure.”

“If [your] company and FDA recommended that you need to have a CAPA procedure, when you investigate then you need to read 192 and put all components that [are] required for investigation into your procedure,” Thakker continued. “That will help reduce the nonconformities or CAPA or thorough investigation issues [related to] 192. There are 483s written and warning letters are also given.”

“If I want to give a message to everybody: it’s a hard road, but read the regulation,” Thakker said. “You need to read [the] regulation yourself, interpret it, and implement [it]. Because your organization is not the same as other organizations. So, taking anything from a different organization, you might bring some issues from the other organization with it. So, you need to read, understand, and interpret the regulation in your company.”