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According to 21 CFR 211.186, what specific information must be included in master production and control records?

Knowledge QAGeneral Gmphard

Question

According to 21 CFR 211.186, what specific information must be included in master production and control records?

Choices

A. Only the product name and a list of ingredients
B. The name and strength of the product, a list of components with quantities, complete manufacturing and control instructions, in-process controls, and specifications
C. Product name, lot number, and final testing results only
D. Manufacturing instructions are sufficient; control instructions may be maintained separately without cross-reference

Cross-Model Comparison

Model	Score	Latency	Tokens In	Tokens Out
GPT-5.4	100.0%	2.6s	102	134
GPT-5.4 mini	100.0%	959ms	102	52
GPT-5.4 nano	100.0%	962ms	102	68
Claude Haiku 4.5	100.0%	2.9s	108	269
Claude Sonnet 4.6	100.0%	8.5s	108	357
Llama 4 Scout	100.0%	740ms	106	235
Claude Opus 4.6	100.0%	12.4s	108	391
Llama 4 Maverick	100.0%	17.4s	106	371
Llama 3.3 70B Instruct	100.0%	2.1s	107	194
Mistral Small 2603	100.0%	1.9s	118	301
Qwen3.5-397B-A17B	100.0%	27.7s	112	1,796
DeepSeek-V3.2	100.0%	17.2s	101	182
DeepSeek-R1	100.0%	10.1s	107	323
DeepSeek-R1-Distill-Qwen-32B	100.0%	100.4s	104	646
Mistral Large 3 675B	100.0%	4.4s	106	269
Qwen3.5-35B-A3B	100.0%	6.8s	112	1,199
Gemini 3.1 Pro	100.0%	19.5s	105	1,034
Gemini 3 Flash	100.0%	3.5s	104	389
Gemini 3.1 Flash-Lite	100.0%	2.5s	104	294

Tags

batch_recordsmaster_recordsdocumentation