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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

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

Cross-Model Comparison

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Tags

batch_recordsmaster_recordsdocumentation