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

For a finished product containing more than one API, the information requested for Part  II S should be provided entirely for each API 

Separate DMF/CEP/Part II S must be provided entirely for each API for:

  1. Finished product contains more than one API
  2. API from different manufacturing site
  3. API from different synthesis route

API submission Option:

  • CEP
  • DMF
  • ACTD

References:

Appendix 6 : Guideline On Regulatory Control Of Active Pharmaceutical Ingredients (APIs)

S(i) : Certificate of Suitability (CEP)
  • CEP Number
  • CEP Issue Date
  • CEP Expiry Date
  • CEP Certificate

References:

Appendix 6 : Guideline On Regulatory Control Of Active Pharmaceutical Ingredients (APIs)

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 : API Manufacture(s) Name & Address
S 2.1.1 : Other API Manufacture(s) involved
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 : Stability Data
S 7.1 : Re-test Period Months
S 7.2 : Shelf Life Months
S 7.3 : Stability Data Attachment
S 7.4 : Storage Condition
S 8 : Drug Master File (DMF)
S 8.1 : Letter of Access

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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