The European Annual Conference of the International Society of Pharmaceutical Engineering (ISPE) attracted over 700 participants to Dublin from 1st to 3rd April 2019. The main topic was “Drive and Leverage Innovation for Pharma”.
One of the hot topics was ICH Q12 Product Life Cycle Management. It was excellently discussed in the Executive Forum and also in Track 3: Quality Risk Management, Process Validation, Continuous Process Verification & GAMP®.
In today’s leading article I have summed up two top-class lectures on the challenges and advantages of ICH Q12. I have also published this text (and much more) in my live coverage of the conference at Linkedin (#gmppublishing).
“ICH Q12 - Set menu or buffet?”, this question asked Graham Cook, Pfizer Pharmaceuticals and EFPIA Q12 Topic Lead, in his excellent presentation “ICH Q12: Making Change Easier“.
The ICH Q12 Guideline Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management reached Step 3 of the ICH process. In November 2017, it was published for consultation. More than 900 comments were received.
Product lifecycle management is a global challenge. Post-approval changes (PAC) take too long to implement. Around the world, the PAC system is totally heterogeneous. The system is globally insufficient.
Graham presented observations about the regulatory frameworks for PAC:
Challenges for industry are the diversity, the time needed and the approval times. Graham saw several opportunities for harmonization:
Objectives and potential benefits of ICH Q12 inter alia include:
Coming back to the question right from the beginning - ICH Q12 - Set menu or buffet?, Graham explained that ICH Q12 is an optional document. It introduces tools and concepts you can adopt, but you don’t have to. You can pick up what fits your products and operations.
1. Established Conditions
Necessary elements that are important for quality (subject to variation) – they differ from supportive information that would not require a regulatory submission.
2. Post-Approval Change Management Protocol (PACMP)
Regulatory tool that provides predictability regarding the information required to support a CMC change. It speeds up process.
Q12 is already serving as an agent for change within agencies to simplify the management of PACs.
Graham recommended to raise awareness and facilitating change within agencies.
Ursula Busse, Novartis, outlined in her lecture that ICH Q12 has the potential to be a transformational guideline for the management of post-approval technical changes.
Why do we need ICH Q12?
Novartis has to handle about 10,000 changes per year. This is costly inter alia due to fees and stability studies. And with the more and more complex products you have the double amount of regulatory relevant changes.
Ursula presented the comprehensive tool box of ICH Q12. Tools should reduce regulatory burden and facilitate assessment and inspections. Tools are inter alia: Established Conditions (ECs), Post-Approval Change Management Protocols (PACMPs), PQS and categories of post-approval CMC changes.
Implementation challenges need to be understood and addressed:
For commenting the draft guideline, different industry associations got together and provided one set of comments.
Some of the industry comments referred to:
One of the big concerns is different understanding by regulators of old and new concepts. There will be a lot of dialogue needed to overcome the risk of divergence.
In non-ICH regions there are at least WHO guidelines on changes to approved products. But the WHO guidelines are not necessarily implemented. Nevertheless, we But we should encourage implementation of WHO guidelines – they are complementary to ICH Q12
Ursula mentioned many different things like dialogue, courage, examples, trust, harmonization, convergence and clarity. She closed her stimulating and motivating presentation with the advice:
2019 ISPE Europe Annual Conference:
Graham Cook, Sr Director Process Knowledge/Quality by Design, Pfizer: ICH Q12: Making Change Easier
Ursula Busse, Head Quality Intelligence, External Engagement, Novartis: ICH Q12: Challenges to Global Implementation – An Industry Perspective
Sabine Paris, PhD
Maas & Peither AG – GMP Publishing