This document focuses on contamination control practices against microbial and other adventitious agents, endotoxins, and foreign particulate matter in the manufacture of sterile drugs, low bioburden drug substances, and some nonsterile drugs that are vulnerable to contamination. Available to download.

2018年11月20日 · Before smartphones ruled the roost, personal digital assistants (PDAs) walked the Earth. Let's look back at the era of dedicated PDAs: roughly 1992 to 2007.

PDA . Technical Report No. 90: Contamination Control Strategy. Development in Pharmaceutical Manu-facturing Technical Report. provides guidance on how to establish an effective CCS for either a new or existing drug manufacturing facility or process. 1.2cope S. This document focuses on contamination control practices against microbial and other ...

2023年5月25日 · The recently published PDA Technical Report No. 90: Contamination Control Strategy Development (TR-90) in February 2023 presents the CCS through a combination of these linked elements: foundation, contamination controls, validation of controls, monitoring of controls and governance, demonstrating the CCS in a methodical manner (see Figure 1 ...

PDA于2023年2月发布了第 90 号技术报告《药品生产中的污染控制策略开发》，对无菌药物、低生物负荷原料药和易受污染的非无菌药物生产中的污染控制实践进行了介绍，并指出，报告中的原则可以更广泛地应用于任何药物生产或混合工艺。 本文对PDA TR 90的内容做简要概述。 1. 污染控制策略的要素. 为了防止生产过程和设施中的污染，应使用质量风险管理（QRM）原则来识别和评估风险。 污染控制策略（CCS）应设计有冗余的单独控制要素，以防止单一要素失效造成 …

This document focuses on contamination control practices against microbial and other adventitious agents, endotoxins, and foreign particulate matter in the manufacture of sterile drugs, low bioburden drug substances, and some nonsterile drugs that are vulnerable to contamination.

2023年5月18日 · The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach.

A personal digital assistant (PDA) is a multi-purpose mobile device which functions as a personal information manager. Following a boom in the 1990s and 2000s, PDA's were mostly displaced by the widespread adoption of more highly capable smartphones, in particular those based on iOS and Android in the late 2000s, and thus saw a rapid decline ...

2023年2月15日 · PDA发布技术报告第 90 号《药品生产中的污染控制策略开发》4~7章 https://mp.weixin.qq.com/s/1pwlLuUVbRQQ06HFd-gRJQ

PDA Technical Report No. 90 (TR 90) Contamination Control Strategy Development in Pharmaceutical Manufacturing