Under EU GMP Part I Chapter 1, what is the purpose of a Corrective Action and Preventive Action (CAPA) system?

Choices

1. A. CAPA is only required for product recalls
2. B. CAPA should address the root cause of deviations and implement measures to prevent recurrence (corrective) and to prevent potential issues from occurring (preventive)
3. C. CAPA only applies to manufacturing deviations, not laboratory OOS results
4. D. CAPA is a recommended but not mandatory element of a pharmaceutical quality system