Models have been used in the manufacture of pharmaceutical and biological products for many years, especially for small molecules drug products.

Yet, the benefit of being able to predict a product or process attribute or a manufacturing parameter without having to measure them has been increasingly offset by the regulatory burden of updating those models during their lifecycle. As large molecule teams have started to use models for development, they wanted to avoid a similar situation for future commercial products.

A team of subject matter experts from BioPhorum, different industry groups, PPAR and the IQ consortium came to an agreed industry position through the sponsorship of BioPhorum’s Regulatory Governance team. This is stated in BioPhorum’s Industry Proposal: Regulatory Submission and Lifecycle Management Strategy of Models used in the Manufacture of Pharmaceutical and Biological Product.

The paper has been designed to ensure that health agencies can review and/or inspect and assess models and how they can bring benefits to the characterization of products and processes, but without excessive burden.

A simple position for all

The proposal recommends a simple principle that applies to a small or large molecule team, drug substances and drug products. It demonstrates that not every model requires registration and not every change to a model requires a submission to regulatory agencies for review – these situations are all clearly defined in the paper and illustrated through five case studies.

The recommendation follows the principles of WHO and ICH guidance to drive harmonization of future regulatory requirements and expectations.

The team has already presented the paper at two conferences. Isabelle Lequeux, Facilitator in BioPhorum’s Regulatory Governance team, presented it at the DIA Regulatory Submissions and Information and Document Management Forum, as an example of how industry is collaborating on proposed regulatory and submission simplification. It was also presented at the IFPAC conference as part of the regulatory workshop co-chaired by Thomas O’Connor from the FDA.

The team will also take the opportunity to comment on the development of ICH guidelines so that BioPhorum’s position can be included as part of the Council’s reflections.

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

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Release Date - 14th January 2021

Abstract

A dedicated task force, representing a collaboration between BioPhorum, the International Consortium for Innovation and Quality in Pharmaceutical Development (the IQ Consortium) and the Pharmaceutical Process Analytics Roundtable (PPAR) has come together to make an industry proposal to national regulatory authorities (NRAs) for standardizing the definition of models used in the manufacture and analytical testing of active pharmaceutical ingredients (APIs), drug substances (DS) and drug products (DPs) for small and large molecules (pharmaceuticals and biopharmaceuticals) and to put forward a strategy for regulatory submission and lifecycle management.