IPEC e-newsletter - Excipients Insight January 2018 - 20-01-18


Inside this issue


Revised ICH Q12 draft reaches step 2b

In December, the International Council for Harmonisation (ICH) began a 12-month public consultation on its draft Q12 guideline, which aims to provide a framework for pharmaceutical lifecycle management for manufacturing changes to already approved drugs.

The draft guideline – which is at step2b in the ICH process – “provides … a framework to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle,” according to the document.

ICH Q12 is intended to complement ICH’s quality guidelines (Q8 to Q11) and according to the organization will enhance the management of post-approval changes, and transparency between industry and regulatory authorities.

The document points put that in certain ICH regions, the current version of the ICH Q12 guideline is “not fully compatible with the established legal framework with regard to the use of explicit Established Conditions ('EC') referred to in Chapter 3 and with the Product Lifecycle Management ('PLCM') referred to in Chapter 5 as outlined in this guideline.”

The EMA said the draft "strives to promote, for regulators (assessors and inspectors), an improved understanding of the applicants’ pharmaceutical quality systems (PQSs) for management of post-approval CMC changes." It is accompanied by three annexes that provide examples of ECs, PLCMs and post-approval CMC changes.




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