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\nICH HARMONISED GUIDELINE  \nCONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS  \nQ13  \nFinal version  \nAdopted on 16 November 2022  \nThis 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  \nQ13  \nDocument History  \n\n| Code | History | Date |\n| --- | --- | --- |\n| Q13 | Endorsement by the Members of the ICH Assembly under Step 2 and release for public consultation. | 27 July 2021 |\n| Q13 | Adoption by the Regulatory Members of the ICH Assembly under Step 4. | 16 November 2022 |\n\nLegal 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.  \nThe 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.  \nThe 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.  \nICH HARMONISED GUIDELINE  \nCONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND  \nDRUG PRODUCTS  \nQ13  \nICH Consensus Guideline  \nTABLE OF CONTENTS  \nPART I: CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS................................................................................................................................... 1  \n1. INTRODUCTION ................................................................................................................. 1  \n1.1. Objective .................................................................................................................................. 1  \n1.2. Scope........................................................................................................................................ 1  \n2. CM CONCEPTS.................................................................................................................... 1  \n2.1. Different Modes of CM ........................................................................................................... 1  \n2.2. Batch definition........................................................................................................................ 2  \n3. SCIENTIFIC APPROACHES ............................................................................................. 2  \n3.1. Control Strategy ....................................................................................................................... 2  \n3.2. Changes in Production Output ................................................................................................. 6  \n3.3. Continuous Process Verification ............................................................................................. 7  \n4. REGULATORY CONSIDERATIONS ............................................................................... 7  \n4.1. Description of Manufacturing Process and Process Controls.................................................. 8  \n4.2. Control Strategy ...............................................................................","cbCaigKt4ndtfcN6","https://ap.wps.com/l/cbCaigKt4ndtfcN6","pdf",1089790,46,"English","# PART I: CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS\n## 1. INTRODUCTION\n## 2. CM CONCEPTS\n## 3. SCIENTIFIC APPROACHES\n## 4. REGULATORY CONSIDERATIONS\n## 5. GLOSSARY\n## 6. REFERENCES\n# PART II: ANNEXES\n## ANNEX I: CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES (CHEMICAL ENTITIES)","[{\"question\":\"When was the ICH Q13 guideline adopted and what version does this document represent?\",\"answer\":\"The guideline was adopted on 16 November 2022 and this document is the final version.\"},{\"question\":\"What topics are covered in Part I of the ICH Q13 guideline?\",\"answer\":\"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.\"},{\"question\":\"What is the scope of Annex I in Part II?\",\"answer\":\"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.\"}]","ICH Harmonised Guideline - Q13 - Continuous Manufacturing of Drug Substances and Drug Products - Final version | PDF",1790931434,116]