RESUMO
The European Medicines Agency (EMA) has approved five pandemic COVID-19 vaccines (prior to April 2022) and many others are in the pipeline. The commentary describes how timely approval and rapid manufacturing capacity scale up could be achieved from our perspective. The commentary considers the need for: early, continuous engagement with the regulator for COVID-19 vaccines; understanding key Chemistry, Manufacturing and Controls (CMC) challenges in order to build a successful COVID-19 vaccine CMC dossier; investing in production and testing site readiness for COVID-19 vaccines; CMC Lifecycle and post-approval planning for COVID-19 vaccines as well as future directions including international regulatory cooperation. EMA's experience of the CMC scientific considerations, which facilitated both timely approvals (as Conditional Marketing Authorisations) and rapid increase in production capacity and supply, is of interest to healthcare professionals, academia, pharmaceutical industry and global regulators to communicate the flexibility and agility applied to COVID-19 vaccines by the EU regulatory system and how these activities can be optimised while complying with the strict quality standards in the EU.
Assuntos
Vacinas contra COVID-19 , COVID-19 , COVID-19/prevenção & controle , Comércio , Atenção à Saúde , Indústria Farmacêutica , HumanosRESUMO
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.
Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Legislação de Medicamentos , Preparações Farmacêuticas/síntese química , Controle de Qualidade , Tecnologia Farmacêutica/legislação & jurisprudência , Fluxo de Trabalho , Qualidade de Produtos para o Consumidor , Contaminação de Medicamentos/legislação & jurisprudência , Contaminação de Medicamentos/prevenção & controle , Indústria Farmacêutica/instrumentação , Indústria Farmacêutica/métodos , Indústria Farmacêutica/normas , Indústria Farmacêutica/tendências , Contaminação de Equipamentos/legislação & jurisprudência , Contaminação de Equipamentos/prevenção & controle , Falha de Equipamento , Europa (Continente) , Guias como Assunto , Humanos , Legislação de Medicamentos/tendências , Segurança do Paciente , Preparações Farmacêuticas/normas , Tecnologia Farmacêutica/instrumentação , Tecnologia Farmacêutica/métodos , Tecnologia Farmacêutica/normas , Tecnologia Farmacêutica/tendências , Estados Unidos , United States Food and Drug AdministrationRESUMO
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.
RESUMO
The purpose of this article is to present the evolution of quality principles and how they have been implemented in the pharmaceutical industry. The article discusses the challenges that the FDA PAT Guidance and the ICH Q8, Q9 and Q10 Guidelines present to industry and provides a comprehensive overview of the basic tools that can be used to effectively build quality into products. The principles of the design of experiments, the main tools for statistical process analysis and control, and the requisite culture change necessary to facilitate statistical, knowledge-based management are also addressed.