Update on E.13 Field for Approved Product

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Quest 3 + (E.13 Submission for Data Cleaning)

 

  • For the purpose of data cleaning and E.13 update on approved product
  • Applicant should submit the documents by separating the documents based on test category
  • To ensure documents are clearly separated based on method and for future use, IF applicant wishes to conduct variation on any of the test  method individually

 

Example of attachment on Diclofenac Sodium 50mg Tablet as follows; 
 

Test Category

Method

Description

Others

Compendial

Assay test of Diclofenac

Sodium by HPLC method

Others

Non-Compendial (In-  House)

Related Substance test of  Diclofenac Sodium by UPLC  method

Others

Non-Compendial (In-  House)

Dissolution Test of Diclofenac  Sodium by HPLC method

Others

Compendial

Microbial Contamination Test  (Membrane Filtration Method)

 

*All documents related to the test can be attached under a single Document under each test category if the document is too large applicant can split document to Document 2, 3 and so on.

 

 

 

 Summary of Method Validation is compulsory field. Therefore, please submit the summary of test method.

  • The summary must contain result of the parameter in comparison to the acceptance criteria.
  • Protocol Validation, Other Documents is not mandatory.

National Pharmaceutical Regulatory Agency (NPRA)
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  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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