Module 3 - Strategic case studies in practice

ICH Q12 Guideline

ICH HARMONISED GUIDELINE

TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT Q12

ICH Consensus Guideline TABLE OF CONTENTS

1 INTRODUCTION............................................................................................................ 6 1.1 Objectives ............................................................................................................ 6 1.2 Scope ................................................................................................................... 7 1.3 ICH Q12 Regulatory Tools and Enablers............................................................ 7 2 CATEGORISATION OF POST-APPROVAL CMC CHANGES .................................. 9 3 ESTABLISHED CONDITIONS (ECS) ......................................................................... 10 3.1 Introduction ....................................................................................................... 10 3.2 ECs in the Regulatory Submission .................................................................... 10 3.2.1 ECs Definition .................................................................................. 10 3.2.2 ECs in a Regulatory Dossier............................................................. 10 3.2.3 Identification of ECs......................................................................... 11 3.2.3.1 Identification of ECs for the Manufacturing Processes 11 3.2.3.2 Identification of ECs for Analytical Procedures ........... 13 3.2.4 Revision of ECs ................................................................................ 14 3.3 Roles and Responsibilities................................................................................. 14 4 POST-APPROVAL CHANGE MANAGEMENT PROTOCOL (PACMP) ................. 15 4.1 Definition of a PACMP ..................................................................................... 15 4.2 Application of a PACMP................................................................................... 15 4.3 Elements of a PACMP....................................................................................... 16 4.4 Modification to an Approved PACMP.............................................................. 17 4.5 Types of PACMPs............................................................................................. 17 5 PRODUCT LIFECYCLE MANAGEMENT (PLCM) DOCUMENT ........................... 18 5.1 PLCM Document: Scope.................................................................................. 18 5.2 Submitting the PLCM Document ...................................................................... 18 5.3 Maintenance of the PLCM Document............................................................... 18 5.4 Format and Location of PLCM Document........................................................ 18 6 PHARMACEUTICAL QUALITY SYSTEM (PQS) AND CHANGE MANAGEMENT ........................................................................................................... 19 6.1 PQS General Considerations ............................................................................. 19 6.2 Change Management Across the Supply Chain and Product Lifecycle ............ 20 7 RELATIONSHIP BETWEEN REGULATORY ASSESSMENT AND INSPECTION20 8 STRUCTURED APPROACHES FOR FREQUENT CMC POST-APPROVAL CHANGES ..................................................................................................................... 21

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