usp665和BPOG的实施
专职专家
尼克·莫理Principal Scientist for 生命科学 曼彻斯特, 尼克·莫理 has over 15 years of pharmaceutical laboratory experience predominantly specializing in extractables and leachables.
本文提供了关于的关键信息 USP 665, USP 1665, and the Biophorum (BPOG) extractable protocol, to support the pharmaceutical manufacturing sector in complying with these new, 强制性标准. Learn more about single-use bioprocessing systems used in the production of biopharmaceutical drug products and how the risk management process is defined.
你准备好USP 665和BPOG了吗?
USP 665 and USP 1665 standards were approved in early 2023 to address the risk of extractables and leachables (E&L) in plastic components and systems used in the manufacture of pharmaceutical products. USP 665 is mandatory and comes into effect on May 1, 2026.
为什么法规会发生变化?
Pharmaceutical manufacturing processes traditionally used glass and stainless-steel equipment. 今天, polymeric single-use manufacturing equipment is seen as advantageous over traditional materials. The Increased use of single-use technologies in the biopharmaceutical industry has led to a shift in the end-user/supplier relationship. USP 665 outlines considerations for characterizing and qualifying plastic components.
为什么要下载这份白皮书?
本白皮书解决了E&L测试适用于塑料部件 usp665, USP1665和BPOG指南.
Our industry-leading research analyzes test protocols implemented to achieve regulatory compliance for the manufacture of pharmaceutical/biopharmaceutical products.
对你的产品做出明智的决定, extractables must be identified and characterized through testing. Our team is focused on helping you achieve regulatory approval and by downloading this paper, 你离你的目标又近了一步.
For more information about this white paper or about our services, 今天和我们谈谈.
找到相关的 资源
usp665和BPOG的实施: abstract
通过一个假设的案例研究, this Whitepaper provides an overview of USP<665>, USP<1665> and the Biophorum (BPOG) Extractable protocol for Single-Use bioprocessing systems used in the production of biopharmaceutical drug products.
另外, this paper highlights how the risk management process, defined in USP<665> and USP<1665>, can be implemented using a hypothetical scenario.
usp665和BPOG的实施: excerpt
'Regulatory agencies require end-users to ensure that the materials used to manufacture the pharmaceutical/biopharmaceutical product are suitable for their intended use. In this regard USP<665> has been drafted with the end process in mind, the level of testing and reporting thresholds required for data are therefore, 与进程相关的.'
作者简介
作为生命科学的首席科学家 曼彻斯特, 尼克·莫理 has over 15 years of pharmaceutical laboratory experience predominantly specializing in extractables and leachables.
As a trusted authority within the Life Science industry, Nick provides clients with technical guidance for design studies, 作者白皮书, presents at conferences and collaborates with external scientific organisations to keep up to date with the latest trends.
Nick is passionate about helping our clients deliver innovative products that enable patients to live healthier and more comfortable lives.
尼克·莫理
可推断出的 & 可滤取的研究
im体育APP has one of the largest and most experienced extractables and leachables (E&L)世界上的实践.
以监管专业知识为后盾, 丰富的经验, 以及一个庞大的可提取数据库, 我们的综合E&L solutions ensure the safety of materials used across the healthcare sector.
我们为制药im体育平台app下载提供量身定制的研究, 生物, 医疗设备, 风险降低, 组合产品等, 符合监管预期.
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