As a Pharmaceutical company, you are required to investigate the cause of quality failures or production problems. Surprisingly though, “Failure to thoroughly investigate…” is a common finding from regulatory inspections in the PIC/S, TGA and FDA GMP environment.
To conduct effective failure investigations and perform root cause analysis you must ensure that you have a structured investigation process driven by your corrective and preventive action (CAPA) system.
“CAPA is a well-known cGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence.”
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, 2006
Despite CAPA references in the PIC/S Guide to GMP and FDA 21 CFR Part 211 and a dedicated section in the ICH Q10 (Pharmaceutical Quality System) guideline, CAPA continues to plague pharmaceutical companies.
To extract the most out of your CAPA system, you must:
- Understand the language of investigation, problem solving and CAPA
- Identify regulatory requirements and expectations related to failure investigation, root cause analysis (RCA) and CAPA
- Know when to use risk assessment
- Outline the steps in a common failure investigation and root cause analysis process
- Understand when and where to apply problem solving methods and tools
- Document failure investigation and root cause analysis process activities
- List the essential features of effective CAPA systems
- Ensure your CAPA process is efficient and effective
Contact us for advice on how to get more value from your CAPA system and address concerns with quality or production of your pharmaceuticals. We can help you eliminate causes of non-conformities and prevent their occurrence or recurrence. You may also be interested in our CAPA training course.
