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

1 For a drug product containing more than one drug substance, the information requested for part “S” should be provided in its entirety for each drug substance

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

Reference National Pharmacy Regulatory Agency (formally known as National Pharmaceutical Control Bureau):

Drug Registration Guidance Document (DRGD) – 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


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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