Case Studies

Pharma CAPA

Pharma CAPA

Sector Pharmaceutical

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 organisation. This paved the way for superior performance in regulatory audits and compliance to higher regulatory standards.

Situation – The Objectives for Pursuing CAPA

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.

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.

Sustenance Audits:
They also want 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 – deep dive

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:

Basic CAPA Tool:

  • CAPA fundamentals
  • Root-cause analysis
  • Sampling & data analysis
  • 7 QC Tools
  • Solution development

Level 2: Foundation Tools:

  • To check the stability of the process
  • To check if the process performance is normal
  • To establish control in process and monitor them using control charts
  • To establish control limits and define standard operating procedures
  • To perform risk assessment for the process
  • To solve problems using statistical approach

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

Results – deep dive

  • 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 organisation’s image thus leading to rapid growth in revenues.