FDA and CAPA

The FDA issued 74 good manufacturing practice (GMP)-related warning letters to device firms last year, 84 percent of which contained citations for Corrective Action Preventive Action (CAPA) system deficiencies.

FDA Focusing:

  1. On CAPA system deficiencies
  2. On right to review all CAPAs even when companies begin them as a result of internal audits

Why CAPA

CAPA management is integral to meet the FDA’s expectations and its GMP regulations. More than just a regulatory requirement, effective CAPA management also is a good business practice that can reduce company liability and warranty claims and increase customer satisfaction.

SOLUTION

Effective CAPA systems reduce regulatory risk by managing and streamlining the quality-reporting process.

Advantage:

  1. Reduces bad inventory
  2. Generates fewer regulatory warnings and recalls, and
  3. Increasing company profits and customer satisfaction

More here>>

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