According to EU GMP Annex 1 (2022 revision), when performing Aseptic Process Simulation (media fills) for conventional aseptic filling, what is the maximum acceptable number of contaminated units when filling fewer than 5,000 units?

Knowledge QAEu Annex1hard

Question

Choices

A. Zero contaminated units
B. One contaminated unit with an investigation
C. One contaminated unit should result in a failed media fill; however any contaminated unit requires investigation
D. Up to 0.1% of total units filled

Cross-Model Comparison

Model	Score	Latency	Tokens In	Tokens Out
Gemini 3.1 Flash-Lite	100.0%	1.8s	105	163
GPT-5.4 mini	100.0%	959ms	106	86
DeepSeek-V3.2	100.0%	27.7s	106	280
DeepSeek-R1	100.0%	11.4s	112	368
Mistral Large 3 675B	100.0%	5.1s	110	298
Gemini 3 Flash	100.0%	2.8s	104	252
GPT-5.4	100.0%	1.7s	106	75
Claude Haiku 4.5	100.0%	3.7s	121	323
Claude Sonnet 4.6	100.0%	8.9s	121	356
Claude Opus 4.6	100.0%	12.1s	121	387
Llama 3.3 70B Instruct	100.0%	2.1s	113	154
Llama 4 Maverick	100.0%	4.4s	112	473
DeepSeek-R1-Distill-Qwen-32B	100.0%	30.1s	109	636
Mistral Small 2603	100.0%	1.6s	122	232
GPT-5.4 nano	0.0%	1.0s	106	94
Qwen3.5-35B-A3B	0.0%	74.3s	116	10,326
Qwen3.5-397B-A17B	0.0%	145.1s	116	8,754
Gemini 3.1 Pro	0.0%	23.1s	104	1,361
Llama 4 Scout	0.0%	2.8s	111	223

According to EU GMP Annex 1 (2022 revision), when performing Aseptic Process Simulation (media fills) for conventional aseptic filling, what is the maximum acceptable number of contaminated units when filling fewer than 5,000 units?

Cross-Model Comparison

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