FAQ
All
No. Class Title
  21   Drug Substance  

When submitting a DMF application, is it acceptable to submit only a batch manufacturing record and not performing the process validations using three industrial batches?

 
  22   Drug Substance  

What is the definition of an API mix? What information must be provided while submitting a DMF for API mix?

 
  23   Drug Substance  

If a potential genotoxic impurity is formed or introduced prior to the final step of the API manufacturing process, under what conditions can one waive routine control of the potential genotoxic impurity in the drug substance specification?

 
  24   Drug Substance  

If a new drug substance is not yet listed in any pharmacopoeial monograph, how does one establish the acceptance criterion for total (organic) impurities in the drug substance specification?

 
  25   Drug Substance  

Should the information of reference standards for all impurities listed in the specification of drug substance be provided in section 3.2.S.5 Reference Standards or Materials?

 
  26   Drug Substance  

What information should be provided when there are multiple sources for a starting material?

 
  27   Drug Substance  

What information on impurities in the drug substance should be included in CTD Section 3.2.S.3.2 when submitting a DMF/API application?

 
  28   Drug Substance  

For starting materials that are not commercially available, what information should be provided on the production of starting materials?

 
  29   Drug Substance  

According to section 3.2.S.2.2 in the DMF Technical Document Checklist annexed to the public promulgation no. DOH 1021401257, information such as "microorganism characterization" and "seed-lot system" should be provided if a drug substance is derived from fermentation process. What specific information should be provided for "microorganism characterization" and "seed-lot system"?

 
  30   Drug Substance  

If metal catalysts are used in the manufacturing process of the drug substance, what data should be provided in order to waive routine control of such metal (elemental) impurities?

 
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