ICH Harmonised Guideline - Q13 - Continuous Manufacturing of Drug Substances and Drug Products - Final version

Oct 2, 2026

Uploaded by Asher

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) publishes the Q13 final harmonised guideline on continuous manufacturing of drug substances and drug products. Adopted on 16 November 2022, it reflects consensus after the ICH process and regulatory consultation at Step 4. The guideline defines continuous manufacturing concepts, discusses scientific approaches such as control strategy and continuous process verification, and covers regulatory considerations including batch description, stability, validation, and lifecycle management, with CTD submission expectations and annexes for chemical entities.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages46

Reading Time1 h 56 min

AccessFree to download

PART I: CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS

1. INTRODUCTION

2. CM CONCEPTS

3. SCIENTIFIC APPROACHES

4. REGULATORY CONSIDERATIONS

5. GLOSSARY

6. REFERENCES

PART II: ANNEXES

ANNEX I: CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES (CHEMICAL ENTITIES)

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS Q13 Final version Adopted on 16 November 2022 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of ICH regions Q13 Document History | Code | History | Date | | --- | --- | --- | | Q13 | Endorsement by the Members of the ICH Assembly under Step 2 and release for public consultation. | 27 July 2021 | | Q13 | Adoption by the Regulatory Members of the ICH Assembly under Step 4. | 16 November 2022 | Legal notice: This document is protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided. The document is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document. The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder. ICH HARMONISED GUIDELINE CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS Q13 ICH Consensus Guideline TABLE OF CONTENTS PART I: CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS................................................................................................................................... 1 1. INTRODUCTION ................................................................................................................. 1 1.1. Objective .................................................................................................................................. 1 1.2. Scope........................................................................................................................................ 1 2. CM CONCEPTS.................................................................................................................... 1 2.1. Different Modes of CM ........................................................................................................... 1 2.2. Batch definition........................................................................................................................ 2 3. SCIENTIFIC APPROACHES ............................................................................................. 2 3.1. Control Strategy ....................................................................................................................... 2 3.2. Changes in Production Output ................................................................................................. 6 3.3. Continuous Process Verification ............................................................................................. 7 4. REGULATORY CONSIDERATIONS ............................................................................... 7 4.1. Description of Manufacturing Process and Process Controls.................................................. 8 4.2. Control Strategy ...............................................................................

FAQs

When was the ICH Q13 guideline adopted and what version does this document represent?

The guideline was adopted on 16 November 2022 and this document is the final version.

What topics are covered in Part I of the ICH Q13 guideline?

Part I includes an introduction, CM concepts, scientific approaches (including control strategy and continuous process verification), and regulatory considerations such as process controls, batch description, stability, process validation, pharmaceutical quality system, lifecycle management, and CTD submission of CM-specific information.

What is the scope of Annex I in Part II?

Annex I provides guidance for continuous manufacturing of drug substances focused on chemical entities, including an example system overview and technical considerations related to control strategy and equipment design and integration.

Oct 2, 2026

Uploaded by Asher