Part II - Section S : Active Pharmaceutical Ingredient (API) Information Submission

Please read Drug Registration Guidance Document (DRGD), Appendix 6: Guideline on Regulatory Control of Active Pharmaceutical Ingredients (APIs) and Guidance Notes before submitting information for Part II Section S.

Separate Part II Section S information (in the same product registration application) should be submitted when:
i.   A finished product contains more than one API
ii.  An API is manufactured from more than one manufacturing site
iii. An API is manufactured using more than one synthesis route
1) How to enter Part II S from QUEST

Please click  "Details" button to open Section S for each API.

Screenshot_1_Details

2) Has This API Been Approved by NPRA
3) Adding API Manufacturer
4) Continue to upload Part II S information
S(i) : Certificate of Suitability (CEP)
S(ii) : Written Statement
Section A: Quality Overall Summary
Section B: Table of Contents
Section C: Body of Data
S 1.1 : Nomenclature
S 1.2 : Proposed Structure
S 1.3 : General Properties
S 2.1.1 : Other API Manufacture(s) involved
S 2.1 : API Manufacture(s) Name & Address
S 2.1.2 : Synthesis Route
S 2.2 : Manufacturing Process and Process Control
S 2.2.1 : Manufacturing Process Flowchart
S 2.3 : Control of Materials
S 2.4 : Controls of Critical Steps & Intermediates
S 2.5 : Process Validation and/or Evaluation
S 2.6 : Manufacturing Process Development
S 3.1 : Elucidation of Structure and Other Characterisation
S 3.2 : Impurities
S 4.1 : Specification of Active ingredient
S 4.2 : Analytical Procedure
S 4.3 : Validation of Analytical Procedure
S 4.4 : Batch Analysis
S 4.4.1 : Certificate of Analysis (COA) of API
S 4.5 : Justification of Specification
S 5 : Reference Standards of Materials
S 6 : Container Closure System
S 7.1 : Re-test Period
S 7.2 : Storage Condition
S 7.3 : Stability Data Attachment
S 8 : Drug Master File (DMF)
S 8.1 : Letter of Access
S 9 : Certificate of Good Manufacturing Practice (GMP) for API Manufacturer
S 10 : Other Supporting Document

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Friday 18 October 2019, 10:30:39.
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