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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RI Regulatory submission and lifecycle management January 2021.pdf
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  • Create Date 14th January 2021
  • DOI https://doi.org/10.46220/2020REG002
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