1.

What Are The Types Of Dmf’s?

Answer»
  • TYPE I: Manufacturing Site, FACILITIES, Operating Procedures, and Personnel (No longer accepted by FDA)
  • Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III: Packaging Material
  • Type IV : EXCIPIENT, Colorant, FLAVOR, Essence, or Material Used in Their Preparation
  • Type V: FDA Accepted Reference Information (FDA discourages its use)



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