Regulatory

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BioPhorum’s expert feedback on the FDA’s ICH Q12 guideline

The globalization of the supply chain and market for medicinal products are complex areas. They have resulted in a growing number of different procedures, rules and country by country regulations that must be followed whenever post-approval changes to chemistry, manufacturing and controls (CMC) are proposed for various reasons. These regulations can stifle innovation and process improvements that ultimately benefit the patients. ICH...

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A simplified way to register complex and innovative raw materials in Europe

The regulatory environment for registering innovative and complex raw materials differs by region and country. All national health agencies need to ensure that products proposed for their markets are safe, effective and of appropriate quality, so they need sufficient information to make that assessment. Most national health agencies have a knowledge platform where raw material suppliers can provide information on non-compendial materials –...

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An industry response to the Danish Medicines Agency’s questions on augmented intelligence and machine learning

The Danish Medicines Agency (DKMA) is working to define criteria for the application of artificial intelligence (AI) and machine learning (ML) across GxP-regulated areas.   To understand industry’s position, it has been gathering information using questions posed as though asked by an inspector assessing the quality of an AI/ML algorithm to control and evaluate product quality.  To form an industry response, BioPhorum gathered a...

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Supplier change notifications – bringing color to a grey area

Regulators require the biopharmaceutical industry to manage changes to raw materials in a compliant way – including those initiated by suppliers. A significant challenge is how to manage the large volume of supplier change notifications (SCNs) while ensuring a compliant and uninterrupted supply of materials for production. Companies often need to manage hundreds of raw material SCNs per year, potentially covering hundreds of materials from a...

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BioPhorum launch new sustainability phorum

BioPhorum members have given us a clear message; to be an industry that supports sustainability is extremely important to them. With no other single organization providing ‘one voice’ for the industry, discussions have been gathering pace to launch a dedicated sustainability phorum. This will become the prime vehicle to translate high-level corporate statements and commitments into practical, on-the-ground, scalable and transferable solutions....

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Raw Materials: Supplier change notifications: change areas and requirements

This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients. By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.

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How to simplify the registration and regulatory lifecycle management of models

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,...

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

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.

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A new framework for greater alignment for the Russian Pharmacopeia

Russian authorities are making progress in aligning with international pharmaceutical guidelines but, like many other countries, are on a journey towards using these to improve the manufacture of biologics for their home market. Yet, some challenges remain. The Russian Pharmacopeia is a comprehensive reference document that oversees the quality of its pharmaceutical products. However, compared to other countries’ publications, Russian...

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How industry is meeting FDA expectations on the impact of COVID-19

In June 2020, the US FDA published Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing. It provides guidance for industry on the impact of the COVID-19 pandemic and on its expectations around good manufacturing practices (GMP). A cross-industry BioPhorum team – consisting of 130+ subject-matter experts across 43 member organizations – has now prepared a...

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