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An industry reflection on the application of the Russian Pharmacopeia to the registration of biologics
240.56 KB 1 file(s)
Release Date - 3rd September 2021
  Drug Substance     regulatory affairs     regulatory compliance     Russia     Testing  
Abstract
In this paper, a BioPhorum member team of experts in biologics and vaccines have summarized the current challenges linked to the registration of global products in Russian Federation. This paper describes some of the challenges faced by the industry in relation to current pharmacopoeial requirements for biologics and vaccines and presents a framework of options and activities that would lead to greater alignment with the ICH and the expectations of other regulatory agencies.
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BioPhorum approach to the registration of innovative raw materials using quality by design (QbD) principles
200.52 KB 2 file(s)
Release Date - 18th January 2022
  Quality by design (QBD)     raw materials  
Abstract
BioPhorum has defined a best practice approach to the registration of innovative and complex raw materials. The approach is based on quality by design(QBD) principles. It is applicable to different families of non-compendial raw materials in the manufacture of biologics. The approach has already been used by BioPhorum member organizations and accepted by national health authorities.
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BioPhorum deliverables mid-year report 2021
6.61 MB 1 file(s)
Release Date - 2nd July 2021
Abstract
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China: Registration of raw materials entering the composition or presentation of biopharmaceuticals
0.00 KB 1 file(s)
Release Date - 15th January 2020
Abstract
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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Covid-19: How industry is using technology during the covid-19 pandemic
4.75 MB 1 file(s)
Release Date - 1st September 2020
Abstract
This article looks at the role of technology in the workplace and specifically how the Senior BioPhorum Connect group is addressing issues such as the use of remote working technologies, cyber security and digitizing the cGMP space.
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Covid-19: Reference for COVID-19 viral control strategy in the biological manufacturing industry – industry position on the FDA guidance
904.53 KB 1 file(s)
Release Date - 23rd October 2020
Abstract
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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Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version
223.94 KB 1 file(s)
Release Date - 21st February 2022
  continuous downstream processing     continuous manufacturing     regulatory     Regulatory Governance  
Abstract
A comprehensive response to ICH Continuous manufacturing of drug substances and drug products Q13 draft version. The BioPhorum team overall think the draft reads well and believes the concepts and ideas are aligned with BioPhorum thinking on continuous manufacturing for biologic drug substance and drug product.
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Industry feedback on ICH Q12: implementation considerations for FDA-regulated products
205.65 KB 1 file(s)
Release Date - 4th October 2021
  CMC     post approval  
Abstract
The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. This document in the industry response to an agency consultation on draft guidance on ICH Q12. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.
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Industry feedback on the bacterial endotoxin test (BET)
158.96 KB 1 file(s)
Release Date - 27th January 2022
  regulatory     USP  
Abstract
This paper contains feedback on the USP document Bacterial Endotoxin Test (BET): A USP Comparability Study of Recombinant Reagents (Recombinant Factor C and Recombinant Cascade) to Lysate Reagents (LAL). The paper comments on issues such as the feasibility of testing the recommended matrix using four different recombinant reagents and four different lysate reagents, and that water post-deionization (low-purity) but before distillation/ultra-filtration (high-purity) is not representative of samples typically tested for bacterial endotoxins. It also questions whether industry will be able to provide known contaminated samples as these would be difficult to obtain and then compare.
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Industry feedback on USP bioreactivity draft monographs
182.87 KB 1 file(s)
Release Date - 31st January 2022
  regulatory     USP  
Abstract
This BioPhorum paper contains feedback on the USP bioreactivity monographs to plastics used for manufacturing, and the use of resources. It also comments on the potential in vitro tests that should be included, the removal of the implantation test and safety, the removal of Class I to VI, and the topics for omission or inclusion into the chapter outline. The expert feedback provided in these documents aims to support the USP and, ultimately, produce documents that improve patient safety – but with adequate use of finite analytical resources, which would not be the case with divergent expectations.
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Industry proposal: Regulatory submission and lifecycle management strategy of models used in the manufacture of pharmaceutical and biological products
395.72 KB 1 file(s)
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.
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Peer to peer practical guidance on remote inspections and audits
208.89 KB 1 file(s)
Release Date - 22nd January 2021
  audit     Covid-19     remote inspection     virtual inspection  
Abstract
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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Post-Approval: General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example Brazil
0.00 KB 1 file(s)
Release Date - 11th March 2019
Abstract
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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Regulatory: Feedback to DMKA questions to critical GXP augmented intelligence
637.13 KB 1 file(s)
Release Date - 7th September 2021
  digital plant     Digital Technologies     GxP     Supply chain digitization  
Abstract
BioPhorum response to work being conducted by The Danish Medicines Agency (DKMA) to define criteria for the application of artificial intelligence (AI) and machine learning (ML) across GxP-regulated areas. The questions  asked by the agency considered the requirements and quality of data used to build, test and validate an algorithm, and how it would respond to biases and deviations in results.
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Russia: In-country analytical testing of biopharmaceuticals, general recommendations
259.41 KB 1 file(s)
Release Date - 3rd March 2020
Abstract
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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Secondary Packaging: Electronic product information
992.32 KB 1 file(s)
Release Date - 26th March 2021
  digital health     electronic packaging     ePI     secondary packaging  
Abstract
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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