Article | December 3, 2024

Diary Of Compliance: A Year In The Life Of Ensuring FDA CAPA Standards

Source: ProPharma
FDA-Approved-GettyImages-1186545957

Acme Pharma’s journey toward FDA CAPA (Corrective and Preventive Actions) compliance, led by Quality Assurance Manager Allison Audit, illustrates the intricate process of aligning with stringent FDA regulations. Over the year, the company focused on overhauling its CAPA system to ensure robust, compliant operations.

In Q1, Acme conducted an internal audit that identified critical gaps in documentation and corrective processes. Guided by FDA regulations such as 21 CFR Part 211 and ICH Q10, the team developed a comprehensive corrective action plan emphasizing root cause analysis and preventive measures. By Q2, Acme transitioned from planning to full-scale implementation. Training programs and CAPA software were introduced to streamline processes and enhance accountability. Monitoring progress became a central focus, with a CAPA review board established to assess and adjust actions as needed. Q3 saw the refinement of preventive measures and preparation for regulatory audits. Mock inspections ensured readiness, leading to a successful FDA inspection with minimal findings. Technological integration, such as CAPA software optimization, strengthened compliance.

In Q4, a comprehensive audit, assisted by third-party consultants, confirmed Acme’s progress in documentation, corrective actions, and employee engagement. Looking ahead, Acme plans to expand training, enhance technology integration, and strengthen supplier management, ensuring continuous FDA compliance and quality improvement.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Cell & Gene? Subscribe today.

Subscribe to Cell & Gene X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Cell & Gene