IPRP ASMF/DMF QAR template - ver. 2.1 - Administrative Information

Sep 1, 2026

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Template for documenting administrative and quality assessment information for an ASMF/DMF used in the IPRP Quality Working Group for Generics. Includes regulatory disclaimer and foreword, version reference, regional information placeholders, material declarations related to BSE/TSE risk, and an assessor introduction section. Provides structured module guidance for the applicant’s part (AP) with detailed subsections covering nomenclature, structure, manufacturing description and controls, characterization studies, impurities thresholds, drug substance control, analytical procedures and validation, batch analyses, specification justification, reference standards, container closure systems, and stability summaries and protocols.

LanguageEnglish

CategoryForms

FormatDOCX

Pages14

Reading Time5 min

AccessFree to download

Administrative Information

ASMF/DMF Quality Assessment Report

Regional Information (to be amended, as needed)

Declarations

Quality Assessor’s Introduction

Module 3 – Quality

Applicant’s Part (AP) of the ASMF/DMF

Original Assessment

3.2.S.1 General Information

3.2.S.2 Manufacture

3.2.S.3 Characterisation

3.2.S.4 Control of the Drug Substance

3.2.S.5 Reference Standards or Materials

3.2.S.6 Container Closure System

3.2.S.7 Stability

3.2.S.7.2 Post-approval stability protocol and stability commitment

Disclaimer This document reflects the views of subject matter experts participating in the IPRP Quality Working Group for Generics (QWGG) and should not be construed to represent the official views of any given regulatory authority participating in the IPRP. Foreword In order to achieve the QWGG’s objective to promote collaboration and convergence in the area of generic drug regulation, the QWGG has developed a series of reference documents covering a number of technical and procedural aspects of assessment. These documents were developed among participating QWGG members and observers as model documents. These QWGG documents have been made available for use by any interested party. The implementation of these documents by a given QWGG member or observer, either as a whole or in part, is not mandatory. Each QWGG member or observer works within their own specific regulatory setting and some or all aspects of a document may, for a variety of reasons, not be applicable. Equally, a given QWGG member or observer may for practical reasons choose to revise the format or written language of a model document. ASMF/DMF Quality Assessment Report Version 2.0 (dated: 2017-06-07) ADMINISTRATIVE INFORMATION This ASMF/DMF is being assessed in conjunction with an application with the following characteristics: REGIONAL INFORMATION (to be amended, as needed) Declarations: Materials of risk of transmitting BSE/TSE agents: It has been declared that no materials of animal or human origin are used in this manufacturing process. OR It has been declared that of animal origin is used in this manufacturing process. QUALITY ASSESSOR’S INTRODUCTION Summary of available literature references on the active/drug substance: Other introductory information: MODULE 3 – QUALITY APPLICANT’S PART (AP) of the ASMF/DMF ORIGINAL ASSESSMENT (AP) 3.2.S.1 General Information 3.2.S.1.1 Nomenclature 3.2.S.1.2 Structure 3.2.S.1.3 General properties 3.2.S.2 Manufacture 3.2.S.2.1 Manufacturer(s) Name, address (including unit/plot/block), and responsibility of each manufacturing facility(ies) (including manufacturer(s) of the intermediates, if sourced from a third party): 3.2.S.2.2 Description of manufacturing process and process controls Flow diagram of the synthetic process(es) from the Applicant’s part of the ASMF/DMF (if lengthy, include as an appendix): It has been confirmed by the Assessor that the flow diagram of the synthetic process provided in the Applicant’s Part of the ASMF/DMF contains sufficient information for the Applicant of the drug product dossier and is consistent with the information provided in the Restricted Part of the ASMF/DMF. See the assessment included under the Restricted Part of this report for a discussion on the detailed manufacturing process and process controls. 3.2.S.3 Characterisation 3.2.S.3.1 Elucidation of structure and other characteristics Studies performed to elucidate the structure (e.g., IR, UV, NMR, MS, elemental analysis) including a brief summary of results and conclusion: Discussion relating to the characterisation of the drug substance (e.g., potential isomerism and identification of stereochemistry, polymorphism, particle size distribution): 3.2.S.3.2 Impurities Drug-related impurities (e.g., starting materials, by-products, intermediates, chiral impurities, degradation products): Applicable thresholds for drug-related impurities as per ICH Q3A guideline: Process-related impurities (e.g., residual solvents, reagents, elemental impurities): Discussion of potential mutagenic impurities: Note: The justification for the proposed acceptance criteria for the drug-related and process-related impurities (and mutagenic impurities, if applicable) is discussed in 3.2.S.4.5. 3.2.S.4 Control of the Drug Substance 3.2.S.4.1 Specification 3.2.S.4.2 Analytical procedures Discussion of in-house analytical procedures (e.g., analytical conditions, methods of quantification, system suitability tests (SSTs)): 3.2.S.4.3 Valida

FAQs

What is the purpose of this ASMF/DMF Quality Assessment Report template?

It standardizes how administrative information and Module 3 quality assessment content are presented for an ASMF/DMF within the IPRP QWGG framework.

What declarations are included under the regional information section?

The template includes BSE/TSE materials declarations, specifying whether no animal or human origin materials are used or indicating which animal-origin materials are used.

Which Module 3 quality topics are covered in the applicant’s part (AP)?

It covers general information, manufacturing and process controls, characterization, impurities, specification and analytical procedures, validation, batch analyses, justification of specifications, reference standards, container closure systems, and stability.

Sep 1, 2026

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