Industry proposal: Regulatory submission and lifecycle management strategy of models used in the manufacture of pharmaceutical and biological products

In this paper, industry presents a harmonized proposal for the registration of models used in the manufacture of pharmaceutical and biopharmaceutical products. The proposal states that a strategy for regulatory submission and lifecycle management of models will depend on the impact of the model on the product control strategy and the impact of the model changes on product quality and/or the ECs (as defined in ICH Q12). Low- and medium-impact models are not registered with the NRAs but are fully managed through the license holder’s PQS.

High-impact models are registered and changes are reported based on the impact of the change on product quality and/or the ECs. The different regulatory strategies described in the Annexes of ICH Q12 are proposed to be used for reporting of the changes to the NRAs (not reported, notification low, notification moderate or pre-approval). Industry’s proposal for the initial registration and regulatory lifecycle management of models used in the manufacture of biological and pharmaceutical products is summarized in Figure 3.

The proposal is intended to maintain quality of the documentation and lifecycle management of manufacturing models, and robust product quality for patients, without excessive regulatory burden for either the NRAs or industry. The BioPhorum/IQ Consortium/PPAR collaboration is looking forward to working with the International Committee for Harmonization (ICH) and the NRAs to discuss and finalize this proposal for the harmonization of regulatory submission and lifecycle management of models in the pharmaceutical and biopharmaceutical industry.

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  • DOI https://doi.org/10.46220/2020REG002
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Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

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Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

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BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

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The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

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AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

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