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 

Section A: Quality Overall Summary

The Quality Overall Summary (QOS) is a summary that follows the scope and the outline of the Body of Data in Module 3. The QOS should not include information, data or justification that was not already included in Module 3 or in other parts of the CTD. The QOS should include sufficient information from each section to provide the Quality reviewer with an overview of Module 3. The QOS should also emphasize critical key parameters of the product and provide, for instance, justification in cases where guidelines were not followed. The QOS should include a discussion of key issues that integrates information from sections in the Quality Module and supporting information from other Modules (e.g. qualification of impurities via toxicological studies discussed under the CTD-S module), including cross-referencing to volume and page number in other Modules. This QOS normally should not exceed 40 pages of text, excluding tables and figures.

 

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 2.2 : 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

National Pharmaceutical Regulatory Agency (NPRA)
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