Regulatory

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Secondary Packaging: Electronic product information

Secondary Packaging: Electronic product information

BioPhorum has created a structure and approach to respond to the challenge of developing ePI solutions that add value to patients and healthcare providers alike highlighting the benefits and challenges of the broad range of factors surrounding the design and implementation of ePI, supporting the objective of finding a solution that can be implemented globally . The packaging perspective on ePI is simple: agree on an ePI format, and packaging functions can agree on how to apply it to product packaging. This paper looks at the opportunities and challenges and recommends the adoption and use of GS1 standards and recommendations both to meet supply chain and point of care needs and as a way to harmonize implementation of regulatory requirements.

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Peer to peer practical guidance on remote inspections and audits

Peer to peer practical guidance on remote inspections and audits

Drawing on their real-world experiences, a group of experts drawn from 28 BioPhorum member companies has provided guidance on the detailed working methods that support a successful remote inspection or audit; for example, how to manage information flows between the inspectors and the site subject matter experts’ team. With the impact of Covid-19 likely to be seen for the foreseeable future, virtual inspections may be required for some time. This guidance will help all stakeholders prepare and to avoid the potential problems of remote inspections and audits.

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

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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Covid-19: Reference for COVID-19 viral control strategy in the biological manufacturing industry – industry position on the FDA guidance

Covid-19: Reference for COVID-19 viral control strategy in the biological manufacturing industry – industry position on the FDA guidance

This paper provides an in-depth exploration of the characteristics of SARS-CoV-2 (the virus) and COVID-19 (the disease). It also discusses how likely these may impact current control strategies that maintain product quality, safety and efficacy in the biopharmaceutical industry. It covers the areas that need to be assessed by biomanufacturers regarding SARS-CoV-2 risks for their patients, employees and products. Mitigation actions for the risks and associated benefits are also proposed. Just as importantly, it also discusses the areas that do not need to be evaluated – as current control strategies for endogenous and exogenous viruses, standards of work and the GMP framework are appropriate to prevent SARS-CoV-2 impacting on product. This is the case when the characteristics of SARS-CoV-2 do not make it unique when compared to the existing controls in place.

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Russia: In-country analytical testing of biopharmaceuticals, general recommendations

Russia: In-country analytical testing of biopharmaceuticals, general recommendations

In 2020 the Russian agency adopted a new testing regimen for biological imports, that moves from testing all batches to testing the first imported batches and then potentially only annually. While the changes are intended to support industry and align with procedures in other regions there is concern that some parts of the approach and unintended consequences may worsen the supply of biological products to patients. This paper makes a series of proposals and recommendations to mitigate these concerns and help alignment between the Russian Federation requirements and those of other prominent agencies.

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China: Registration of raw materials entering the composition or presentation of biopharmaceuticals

China: Registration of raw materials entering the composition or presentation of biopharmaceuticals

Since 2017, it has been mandatory for suppliers of APIs, excipients and packaging materials to register their material in China on the DMF registration platform. While many agencies ask for details of a component’s quality and its impact on products, the Chinese requirements for ‘high risk’ materials, such as those used in biopharmaceuticals, also ask for historical information that is typically proprietary which many suppliers are reluctant to share. This paper summarizes the requirements for raw materials in other ICH countries and compares these to the Chinese approach. The paper also lists all of the details needed for the Chinese registration of biopharmaceutical products’ raw materials in a single place, to help suppliers register their products into this vast market.

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Post-Approval: General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example Brazil

Post-Approval: General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example Brazil

As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (ANVISA) asked BioPhorum to support review of its Post-Approval Change regulation to bring it in line with ICH, but also global WHO guidelines . Brazil’s stability and manufacturing data requirements typically delayed submission of post-approval changes by several months to years. The paper demonstrates how to align the national regulation with international standards, resulting in quicker submissions as well as a more efficient review process for the agency.

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