FAQ
All
No. Class Title
  1   Abbreviated New Drug Application (ANDA)  

What requirements for contract analysis entity of drug products shall be met?

 
  2   Abbreviated New Drug Application (ANDA)  

Is there any clear description of domestic regulation regarding that the scale of process validation should be commercial scale, and it cannot be replaced by pilot scale?

 
  3   Abbreviated New Drug Application (ANDA)  

How the linearity and range for the validation of impurity test procedures in a drug product are determined?

 
  4   Abbreviated New Drug Application (ANDA)  

Some reduced tests analyzed periodically have been recorded in the specification of the drug substance issued from the manufacturer of the drug product. Based on the submitted document, is it acceptable that the certificate of analysis of the batch of the drug substance used for the manufacturing of representative product batch includes the reduced tests without full tests?

 
  5   Abbreviated New Drug Application (ANDA)  

If a copy of CEP provided by the manufacturer of the drug substance is submitted, can residual solvent testing be waived in the specification of the drug substance issued by the manufacturer of the drug product?

 
  6   Abbreviated New Drug Application (ANDA)  

There are several container closure sizes/fills for one drug product. Can we produce one commercial scale batch of bulk product and then fill or package the bulk product in different sizes of the same container closure system?

 
  7   Abbreviated New Drug Application (ANDA)  

Is splitting of tablets testing considered an essential part of release and shelf-life specification for scored tablets with one or more breaklines?

 
  8   Abbreviated New Drug Application (ANDA)  

Is endotoxin testing considered an essential part of shelf-life specification to confirm parenteral products to be pyrogen-free?

 
  9   Abbreviated New Drug Application (ANDA)  

How to perform the repeatability of analytical method validation?

 
  10   Abbreviated New Drug Application (ANDA)  

One identification test method of current drug product specification is to compare the retention time in the assay by HPLC. Can the retention time of HPLC in other test items be added as another identification test method?

 
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