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According to ICH Q7, at what point in the manufacturing process should GMP be applied to the production of an API?

Knowledge QAIch Q7easy

Question

According to ICH Q7, at what point in the manufacturing process should GMP be applied to the production of an API?

Choices

A. GMP applies only to the final isolation and purification steps
B. GMP applies from the step where the API starting material is introduced into the process
C. GMP applies from the synthesis of the first intermediate
D. GMP only applies during packaging and labelling

Cross-Model Comparison

Model	Score	Latency	Tokens In	Tokens Out
GPT-5.4	100.0%	2.0s	85	65
GPT-5.4 mini	100.0%	1.3s	85	49
GPT-5.4 nano	100.0%	867ms	85	58
Claude Haiku 4.5	100.0%	3.5s	93	296
Claude Sonnet 4.6	100.0%	8.3s	93	356
Claude Opus 4.6	100.0%	8.8s	93	346
Llama 4 Scout	100.0%	6.0s	93	407
Llama 4 Maverick	100.0%	16.4s	93	414
Llama 3.3 70B Instruct	100.0%	4.5s	119	150
Qwen3.5-397B-A17B	100.0%	18.6s	95	1,084
Mistral Small 2603	100.0%	1.3s	98	184
DeepSeek-V3.2	100.0%	10.2s	87	128
DeepSeek-R1	100.0%	9.1s	93	291
DeepSeek-R1-Distill-Qwen-32B	100.0%	20.6s	87	526
Mistral Large 3 675B	100.0%	4.2s	86	250
Qwen3.5-35B-A3B	100.0%	15.1s	95	2,867
Gemini 3.1 Pro	100.0%	14.0s	78	802
Gemini 3 Flash	100.0%	2.3s	78	205
Gemini 3.1 Flash-Lite	100.0%	2.2s	78	159

Tags

starting_materialsgmp_application_point