Two International Council on Harmonization (ICH) guidelines covering stability testing and specification setting are undergoing long-overdue revisions and are expected to be “substantially” revised said an industry official at DIA Europe 2023.
Updates on the ICH Q1A-Q1F suite of guidelines on stability testing and the Q6A and Q6B guidelines on setting specifications were prompted by members of the ICH Quality Discussion Group (QDG), which identified stability and specification topics as the “highest priorities” for a majority of their members in November 2020, said Andrew Lennard, who works in CMC regulatory affairs for Amgen.
ICH announced at a virtual meeting in June 2021 that these guidelines would be revised
Lennard said both sets of guidelines go back to the late 1990s and are “falling behind” in terms of incorporating including new technologies and the newer science and risk-based approaches such as quality by design and risk management. He added that the revisions are expected to be “substantial.”
Disparate stability guidelines testing to be combined
Lennard said the stability guideline update will combine five existing stability guidelines, from Q1A though Q1F, into one core guideline that will focus on core stability practice. It is expected that appendixes or annexes to address specific topics will be attached to the core guideline. Training materials also will be included in the guidance.
The update also may include a new section on stability considerations for advanced therapies. ICH released a concept paper as well as a business plan announcing the updates in November 2022.
Lennard expects the guideline will be released for public comment in the fourth quarter of 2024 and a final guideline will be signed off as a Step 4 document in the fourth quarter of 2025.
Harmonization on setting specifications
Christiana Campa, technical R&D advisor and senior fellow at GSK, said the proposed changes to ICH Q6A and ICH Q6B will incorporate the newer science and risk-based approaches that are included in the ICH Q8 through ICH Q12 suite of guidelines.
Similar to the stability guideline, the revision will consolidate the two separate guidelines, one on setting specifications for new drug substances in ICH Q6A and ICH Q6B on setting specifications for biotechnology derived substances, into one guideline.
The revision will signify a shift where specification controls will no longer be the key to ensuring product quality. Instead, specifications will be viewed as part of a holistic control strategy. There will also be a shift from where specifications were set on batch experience to more of a science- and risk-based approach where there is emphasis on clinical relevance, platform knowledge and prior knowledge.
Mats Welin, a senior expert for vaccines and monoclonal antibodies for the Swedish Medical Products Agency, told an industry webinar in December 2021 that the current practice of setting specifications based on a limited number of batches is contrary to the concept of setting specifications tailored to patients and that the ICH Q6B guideline is outdated and needs to be revised, (RELATED: EU official says ICH Q6B is outdated and needs revision, Regulatory Focus, 1 December 2021)
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