“Predefined quality tolerance limits” were introduced to ICH GCP in revision 2 of ICH E6 in 2016. They are mentioned in two paragraphs but with no guidance on how to define or use them. We know from MCC meetings and at the recent MCC Summit, where a working group discussed quality tolerance limits (QTLs) in detail, that many organizations are struggling to implement them. Indeed, over one third of MCC Summit working group participants said they do not currently even use QTLs. We have also had discussions that show many in the industry are confused with the concept and the terminology. For example, a QTL is a threshold level of a measurement parameter but the term is often used to describe the measurement rather than the threshold.
The MCC Centralized Monitoring Community of Practice meeting on 18-Nov-2020 at 10am EST will feature a panel session and open discussion: “Challenges with QTL Implementation”. Following the meeting, MCC will convene a sub-team of industry Subject Matter Experts (SMEs) interested in working collaboratively to catalogue the questions and challenges organizations face with QTL implementation and create a QTL toolkit. MCC experts will lead the group through the process of developing a MCC QTL implementation toolkit that expands our understanding about QTLs, applies “measure the right things at the right time” concepts developed by MCC and assists organizations in implementation. The sub-team will report progress to the Centralized Monitoring Community of Practice on a regular basis. The work will culminate with the publication of an article in an industry journal.
Not a member? Contact Terry Holland, MCC Membership Director, to discuss membership options.