Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, launched a compliance audit strategy to prepared for upcoming FDA inspections.

To protect public safety, the U.S. Food and Drug Administration (FDA) routines audits and assesses companies that manufacture and package drugs. Qualitest wanted to better understand the unique conditions that violate FDA regulations. The leadership team was not in fear of receiving a FDA warning letter. However, being proactive to stay in compliance was the root focus of the strategy.

 

Solution

Qualitest engaged Regulatory Compliance Associates^® Inc. (RCA) to prepare the company in advance of an FDA Audit. RCA reviewed over 170 investigations relating to Qualitest operations to suggest improvements and identify areas of risk.

RCA conducted a mock audit to both ensure the compliance of the client and to maintain their readiness for the actual FDA inspection. RCA’s experienced team of ASQ-CQA and RABQSA certified auditors was available to perform a range of internal audit services, including:

• Supplier
• API
• Contact Manufactures (CMO)
• Internal
• Quality Systems
• Baseline
• Verification
• Clinical (CRO) and Clinical Manufacturing
• Data Integrity
• 503A & 503B
• Combination Products

By working efficiently and by tapping into scheduled downtime, RCA was able to complete the project in three months.

 

Result

Qualitest implemented the recommended changes, including company-wide training, and received no observations during the next FDA inspection.

 

About RCA

Regulatory Compliance Associates^® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

• Founded in 2000
• Headquartered in Wisconsin (USA)
  • Regional offices in Florida, Colorado and Europe
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

To begin the RCA^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.