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

GMP KnowledgeGeneral Gmpmedium
Question

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

Cross-Model Comparison

ModelScoreLatencyTokens InTokens Out
GPT-5.4100.0%2.9s110164
GPT-5.4 mini100.0%1.1s11093
GPT-5.4 nano100.0%960ms11085
Claude Haiku 4.5100.0%3.4s126291
Claude Sonnet 4.6100.0%8.3s126332
Llama 4 Scout100.0%4.6s115354
Claude Opus 4.6100.0%9.1s126405
Llama 4 Maverick100.0%3.6s184403
Llama 3.3 70B Instruct100.0%5.0s140224
Mistral Small 2603100.0%1.5s121210
Qwen3.5-397B-A17B100.0%26.4s1171,347
DeepSeek-V3.2100.0%6.8s109331
DeepSeek-R1100.0%20.1s115766
DeepSeek-R1-Distill-Qwen-32B100.0%102.8s108501
Mistral Large 3 675B100.0%4.6s109298
Qwen3.5-35B-A3B100.0%5.9s117966
Gemini 3.1 Pro100.0%13.1s105797
DeepSeek V4 Pro100.0%13.1s109255
Gemini 3 Flash100.0%3.3s105253
Gemini 3.1 Flash-Lite100.0%1.8s105219
Qwen3.6 27B100.0%49.4s117951
Qwen3.6 35B A3B100.0%7.4s1171,400
DeepSeek-V3.2100.0%11.2s109307
DeepSeek V4 Flash100.0%8.2s109281
Gemma 4 26B A4B IT100.0%1.8s118246
Gemma 4 31B IT100.0%9.8s118240
MiniMax M2.7100.0%2.7s141184

Tags

capaquality_systemroot_cause