A new Quality guideline, ICH Q14 (Analytical Procedure Development) is being proposed in order to facilitate more efficient, sound scientific, and risk-based approval as well as post-approval change management of analytical procedures, and to improve regulatory communication between industry and regulators. ICH Q2(R1) Guideline on Validation of Analytical Procedures is also being revised. Together, these two guidelines will provide harmonized and streamlined concepts for a diverse variety of analytical procedures, including examples. Currently, there is one Expert Working Group (EWG) at ICH that covers both guidelines, and they are expected to be out for public commenting in the first quarter of 2022, having reached step 2b of the ICH harmonization process. The use of an enhanced approach for analytical procedure development using concepts such as the Analytical Target Profile (ATP), the method operable design region (MODR), proven acceptable ranges (PAR), and the application of prior knowledge and risk management principles will be described. Regulatory recommendations for reporting analytical procedure development activities in submissions will be discussed, along with opportunities to present a scientific basis for post-approval Analytical Procedure changes including the use of ICH Q12 tools such as established conditions (ECs). This talk will enable the audience to understand the technical aspects and concepts needed for regulation of modern analytical method development and validation efforts; to understand the background and challenges from industry and global regulatory perspectives and at various stages of the product lifecycle, and to understand the benefits of the harmonization process. Reference: https://database.ich.org/sites/default/files/Q2R2-Q14_EWG_Concept_Paper.pdf Other talks in a potential session could include regulators from the various ICH member countries (e.g. FDA, EMA, PMDA). The proposed presenter is a member of the ICH Q2(R2)/Q14 Expert Working Group, representing PhRMA.
It's to be aligned with the USP < 1220> Analytical lifecycle symposium.
Understand the new concepts from an ICH perspective for analytical procedure development, validation, and lifecycle management, including knowledge management, change management, established conditions, and submission requirements as applied to modern analytical techniques including regulatory requirements and expectations.
A symposium of 2 talks from subject matter experts from ICH and USP and a panel discussion. Additional experts from FDA, EMA, PMDA can be invited. 1. Introduction of topics by moderator (5 mins) 2. ICH Expert (30 min) 3. USP expert (30min) 4. Panel discussion (45 mins)*
The target audience is pharmaceutical scientists, regulatory scientists, quality and CMC professionals. The learnings from this session would be relevant to all products intended to be commercialized in the US.
Learning Objectives:
• Upon completion, participant will be able to understand the current regulatory expectations
• Upon completion, participant will be able to understand the challenges of managing analytical changes throughout the product lifecycle.
• Establish analytical controls to support the analytical target profiles established upon submission.
