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如题，最近得到的资料，由PDA在2022年更新发布的资料。远程及GMP/GDP混合审计的考虑要点（Points to Consider in Remote and Hybrid GMP/GDP Audits）
引述英文简介如下——
Introduction
The ability of the pharmaceutical industry to conduct on-site audits has been impacted by global travel restrictions imposed during the global pandemic caused by the COVID-19 disease. These essential examinations are designed to ensure, through the detection of potential gaps, that all regulated systems are operating in a state of control or, if not, to aid in the timely detection and remediation of noncompliance. Industry has quickly pivoted to the use of remote auditing tools to ensure that the requirements of health authorities and marketing authorizations are being met.
This document describes steps that can be taken to ensure an effective and efficient remote assessment.
It introduces standard nomenclature to describe the types of remote audits and discusses key considerations for their scheduling, duration, planning, conduct, closing, reporting, and follow-up. This document focuses on aspects of auditing that are different in the remote setting than in on-site audits or that have a particular impact in the remote setting. It may assist entities as they work through the challenges of remote and hybrid auditing and determine the changes in practices, standard operating procedures, and quality agreements that are necessary to facilitate effective and efficient remote audits.
In addition, Appendix I provides greater detail on how risk assessment principles can be applied to determine the format and frequency of remote audits. And Appendix II provides additional information that can be used to better understand the role of culture and communication during remote audits.
The Parenteral Drug Association Remote Inspections and Audits Task Force, which oversaw the development of this document, includes auditors, auditees, and consultants from around the world.
PDA developed this document with the goal of encouraging further dialog among industry, health authorities, and suppliers of technology and materials. It does not represent a standard or regulatory guidance.
参考中译（机译）如下——
简介
在由COVID-19疾病引起的全球大流行期间，制药业进行现场审计的能力受到了全球旅行限制的影响。这些重要的 这些必要的检查旨在通过发现潜在的差距，确保所有受监管的系统都在控制状态下运行，或者，如果不是，则帮助及时发现和补救不符合规定的情况。不符合规定的情况。行业已迅速转向使用远程审计工具，以确保满足卫生当局和营销授权的要求。
本文件描述了为确保有效和高效的远程评估所采取的步骤。
它介绍了描述远程审计类型的标准术语，并讨论了远程审计的时间安排、持续时间、计划、实施、结束、报告和跟进等方面的关键考虑因素。本文件重点关注在远程环境下与现场审计不同的审计方面，或者在远程环境下有特殊影响的审计方面。它可以帮助各机构应对远程和混合审计的挑战，并确定为促进有效和高效的远程审计所需的做法、标准操作程序和质量协议的变化。
此外，附录一更详细地介绍了如何运用风险评估原则来确定远程审计的形式和频率。而附录二提供了更多的信息，可用于更好地理解文化和沟通在远程审计中的作用。
负责监督本文件制定的注射剂协会（PDA）远程检查和审计工作组包括来自世界各地的审计师、被审计者和顾问。
PDA制定本文件的目的是鼓励行业、卫生当局和技术及材料供应商之间进一步对话。它并不代表标准或监管指导。
感觉有帮助的话，千万不要吝惜给个专业小红心，这将对我是极大的鼓励。
谢谢。
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发表于 2022-5-30 18:06:07
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