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

Knowledge QAGeneral Gmpmedium

Question

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

Choices

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

Cross-Model Comparison

Model	Score	Latency	Tokens In	Tokens Out
GPT-5.4	100.0%	2.9s	110	164
GPT-5.4 mini	100.0%	1.1s	110	93
GPT-5.4 nano	100.0%	960ms	110	85
Claude Haiku 4.5	100.0%	3.4s	126	291
Claude Sonnet 4.6	100.0%	8.3s	126	332
Llama 4 Scout	100.0%	4.6s	115	354
Claude Opus 4.6	100.0%	9.1s	126	405
Llama 4 Maverick	100.0%	3.6s	184	403
Llama 3.3 70B Instruct	100.0%	5.0s	140	224
Mistral Small 2603	100.0%	1.5s	121	210
Qwen3.5-397B-A17B	100.0%	26.4s	117	1,347
DeepSeek-V3.2	100.0%	6.8s	109	331
DeepSeek-R1	100.0%	20.1s	115	766
DeepSeek-R1-Distill-Qwen-32B	100.0%	102.8s	108	501
Mistral Large 3 675B	100.0%	4.6s	109	298
Qwen3.5-35B-A3B	100.0%	5.9s	117	966
Gemini 3.1 Pro	100.0%	13.1s	105	797
Gemini 3 Flash	100.0%	3.3s	105	253
Gemini 3.1 Flash-Lite	100.0%	1.8s	105	219

Tags

capaquality_systemroot_cause