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annex1-002

GMP KnowledgeEu Annex1medium
Question

Under the revised EU GMP Annex 1, what is the recommended maximum time limit for holding filtered bulk solution before filling in an aseptic process, unless otherwise justified?

Choices

  1. A. No specific time limit is mentioned
  2. B. The holding time should be minimised and a time limit established during process validation
  3. C. 48 hours at controlled room temperature
  4. D. 24 hours under refrigerated conditions only

Cross-Model Comparison

ModelScoreLatencyTokens InTokens Out
Qwen3.8-FlashN/AN/A--
GLM-5.3N/AN/A--
MiniMax M3N/AN/A--
Hy4 PreviewN/AN/A--
Muse Glimmer 30BN/AN/A--
Qwen3.8 Max (2.4T-A95B)N/AN/A--
DeepSeek-R1-Distill-Qwen-32B100.0%24.8s88510
Llama 4 Scout100.0%4.8s92383
Llama 4 Maverick100.0%14.1s92327
Mistral Small 2603100.0%1.2s100172
DeepSeek-V3.2100.0%5.6s87134
Qwen3.5-397B-A17B100.0%39.2s962,153
DeepSeek-R1100.0%10.2s93334
Mistral Large 3 675B100.0%4.8s88278
Qwen3.5-35B-A3B100.0%54.9s967,284
Gemini 3.1 Pro100.0%9.7s83990
Gemini 3 Flash100.0%3.0s83274
Gemini 3.1 Flash-Lite100.0%1.9s83145
Qwen3.6 27B100.0%24.1s961,577
Qwen3.6 35B A3B100.0%6.9s961,308
DeepSeek V4 Pro100.0%10.3s87399
DeepSeek-V3.2100.0%7.3s93160
Gemma 4 26B A4B IT100.0%3.8s96272
Gemma 4 31B IT100.0%6.0s96266
MiniMax M2.7100.0%8.5s119483
GLM-5.2100.0%14.7s94478
Llama 4 Maverick100.0%17.5s150372
Claude Opus 4.8100.0%4.4s137275
Llama 4 Scout100.0%8.8s150344
Llama 3.3 70B Instruct100.0%6.8s153136
Mistral Small 2603100.0%2.4s163298
Mistral Large 3 675B100.0%3.5s151263
Qwen3.5-35B-A3B100.0%13.9s1583,339
Qwen3.6 27B100.0%153.6s1585,738
Qwen3.6 35B A3B100.0%16.2s1581,805
Qwen3.5-397B-A17B100.0%28.4s1582,692
DeepSeek V4 Pro100.0%22.7s14750
DeepSeek-V3.2100.0%3.8s14775
DeepSeek V4 Flash100.0%13.1s14766
DeepSeek-R1100.0%72.0s1461,191
Gemma 4 26B A4B IT100.0%7.6s158308
Gemma 4 31B IT100.0%14.3s158168
MiniMax M2.7100.0%10.0s182647
GLM-5.2100.0%172.7s1546,822
Qwen3.8 27B100.0%11.8s2681,571
Muse Glimmer 30B100.0%17.4s1971,076
Kimi K3100.0%380.5s2279,573
GPT-5.4100.0%1.6s8686
GLM-5.3-Flash100.0%300.7s15410,683
GPT-5.4 mini100.0%939ms8673
GPT-5.4 nano100.0%673ms8634
Claude Haiku 4.5100.0%3.8s96320
Claude Sonnet 4.6100.0%9.8s96349
Claude Opus 4.6100.0%12.7s96437
Claude Haiku 4.5100.0%3.8s160304
GPT-5.6 Sol100.0%3.3s144124
GPT-5.6 Terra100.0%4.2s144151
GPT-5.6 Luna100.0%3.0s144175
Hy4 Preview100.0%125.4s16410,050
MiniMax M3100.0%13.0s317830
GLM-5.3100.0%33.2s1541,328
Claude Opus 5100.0%6.5s225299
Claude Sonnet 5100.0%1.0s2259
DeepSeek V4 Flash0.0%39.6s874,000
Qwen3.8-Flash0.0%156.2s20912,992
Llama 3.3 70B Instruct0.0%119.2s944,000
Qwen3.8 Max (2.4T-A95B)0.0%161.0s2096,925

Tags

aseptic_processingholding_timeprocess_validation