CASE STUDY - EFFECTIVE INVESTIGATION (CAPA)

OVERVIEW

Situation:

ABC Pharma aims to foster a systematic root cause analysis and corrective / preventive action culture within the organization at all levels and across all functions.

Actions Taken:

A core team was formed that was trained on CAPA fundamentals, live projects were taken up to demonstrate the power of CAPA systems.

Results:

CAPA culture was embedded in the organization. This paved the way for superior performance in regulatory audits and compliance to higher regulatory standards.

THE OBJECTIVES FOR PURSUING CAPA

1.Systematic Method of Analysis:

ABC aimed to foster a systematic root cause analysis and corrective/preventive action culture within the organization at all levels and across all functions.

2.Compliance to regulatory requirements:

ABC aimed to implement a system of sustained compliance to regulatory requirements rather than a quick fix approach to dealing with non - conformities.

3.Sustenance Audits:

ABC also wanted SSA to support in ensuring ongoing commitment to this initiative by scheduling periodic reviews and audits at various manufacturing sites.

ACTIONS TAKEN - APPROACH ROADMAP

ACTIONS TAKEN

• A core team was formed that would learn the CAPA fundamentals and apply the knowledge in the ensuing months
• The training was split into two modules:

CAPA projects were undertaken to apply the learning in a “real - world” setting.

RESULTS

• In all, over 100 people from various sites across India were trained and certified as certified CAPA investigators.
• Several CAPA investigation projects were undertaken and successfully closed.
• CAPA investigation procedures were documented as SOPs and ratified by regulatory agencies.
• Superior CAPA compliance and resultant recognition from regulatory agencies helped boosted the organization's image thus leading to rapid growth in Revenues.

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