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Current Step 4 Version Dated 4 June 2008.” ICH Harmonised Tripartite Guideline: Pharmaceutical Quality System. 4International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.Current Step 4 Version Dated 9 November 2005.” “ICH Harmonised Tripartite Guideline: Quality Risk Management. 3International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.Q8(R2): Current Step 4 Version Dated August 2009.” “ICH Harmonised Tripartite Guideline: Pharmaceutical Development. 2International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.All comments and recommendations were considered, and some of this critical feedback resulted in substantial revisions in the final version. The draft version received over 600 consolidated comments and recommendations from regulatory authorities, pharmaceutical industry stakeholders, and various trade groups. During the development process, the ICH Q12 Expert Working Group acknowledged that ICH Q12 was a transformational guideline and it may be challenging for some regions to fully implement all ICH Q12 provisions in a timely manner. The original ICH Q12 concept paper was endorsed in September 2014, and the Step 2 draft was issued for public comments in November 2017. Use of ICH Q12 tools such as Established Conditions and Post-approval Change Management Protocols could drastically reduce the postapproval burden by, for example, reducing the volume of submissions to a single simplified submission to each country for all products thus, the ICH Q12 tools can facilitate changes globally while maintaining product quality and patient safety. The products are sold in 176 different countries, and global implementation of this analytical improvement would require 6,364 licenses 6Īnd take 10 or more years. In the example, an industry central testing lab tests a wide range of different products containing 20 different active pharmaceutical ingredients this lab would benefit from being able to run its tests using a single efficient “always on” method. The implementation of ICH Q12 is intended to provide a framework to facilitate the management of postapproval CMC changes in a predictable and expeditious manner, demonstrate how enhanced product knowledge and process understanding improve regulatory flexibility for postapproval changes, and reinforce the importance of an effective change management system through the product life cycle.įigure 1 illustrates the magnitude of the regulatory burden required to implement an innovative CMC change globally prior to ICH Q12.

More complex changes, such as manufacturing improvements and enhancements that could increase product quality assurance, may take longer or might be abandoned if the regulatory burden outweighs perceived benefits. Post-approval Change Management Protocol (PACMP)Ĭurrently, global regulatory approval of even simple postapproval CMC changes could take more than five years.Product Lifecycle Management (PLCM) Document.ICH Q12 defines various tools and approaches to facilitate CMC change management, including in the following sections of the guideline:

#Ispeak 9781259159497 full

ICH Q12, which was over five years in the making, builds on the framework established in ICH Q8, Q9, Q10, and Q11 2, 3, 4, 5Īnd aims to address key remaining technical and regulatory hurdles that prevented the full adoption and realization of flexible science- and risk-based approaches to post-approval chemistry, manufacturing, and controls (CMC) change management during commercial manufacturing. Appendix comparing the Step 2 draft and the final guideline is available as a download. This article focuses on the final version of ICH Q12, including revisions made after the Step 2 draft was published in 2017.