求助-Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products,2nd

1949stone

求助此文件，谢谢！可用教材或其他文件交换（如果我有）
邮箱：buzhou-wys@163.com

https://guidance-docs.ispe.org/Baseline-Guide-Volume-7-Risk-Based-Manufacture-of-Pharma-Products
Author(s): Naumann, Bruce D., PhD, DABT; Wilkins, Stephanie A.; Dolgin, David D.; Forsyth, Richard; Goldschmidt, Norman A.; Shamez, Rizwan, PhD
The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, for managing the risk of cross-contamination within shared facilities. Risk management processes should be used to determine and document reasonable and acceptable risk, in order to maintain product quality and operator safety and to satisfy regulatory requirements.
The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition provides a process that allows manufacturers to assess risk and determine where control strategies are necessary to meet acceptable limits for cross-contamination. The control strategies to manage risk can vary from administrative to full dedication or segregation. Typically, some combination of control strategies may be necessary. This Guide is intended to provide a consistent approach on setting acceptable limits to assess the potential of cross-contamination, thus enabling implementation of appropriate controls to facilitate safe and affordable drug product manufacturing.
The revision to the ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition acknowledges that the overall principles presented in the first edition are still valid, but includes several changes to support ongoing developments:

• Information has been added to support significant changes in regulations and the application of regulations. These include:
  

• Updated EU GMPs relative to the use of quality risk management principles in managing the risk of cross-contamination.
• EMA issued guideline on setting Health Based Exposure Limits (HBELs) for use in the risk management process for shared facilities. This guidance also states that PDE [Permitted Daily Exposure] and ADE [Allowable Daily Exposure] are effectively synonymous.
• ICH issued M7 guideline “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk”, which sets a Threshold of Toxicological Concern (TTC) for mutagenic impurities in drug substances and drug products when there is insufficient data to calculate the acceptable limit.
• Adoption by U.S. and EU regulators of a lifecycle approach to process validation incorporating three stages of process design, process qualification, and continued process verification. The process validation lifecycle approach recognizes that validation is an ongoing control strategy to manage risks and maintain process control. The concept of ongoing assurance of cleaning process efficacy is one of the keys to the control of cross-contamination outlined in this guide.
• Implementation of risk-based approaches to managing the risk of cross-contamination and sharing lessons learned.
  

• Information has been relocated, so that the layout of the Guide aligns with the ICH Q9 process.
• Updated application example has been added, based on an increased understanding and more experience with Quality Risk Management, and more specifically with risk assessments for cross-contamination.
  

我是QA刘

在博普智库花5元钱可以下载

1949stone

我是QA刘 发表于 2021-10-29 08:57
在博普智库花5元钱可以下载

谢谢  这就是试试

1949stone

我是QA刘 发表于 2021-10-29 08:57
在博普智库花5元钱可以下载

去看了下，不是完整版本，大约缺了60页左右

我是QA刘

1949stone 发表于 2021-10-29 09:47
去看了下，不是完整版本，大约缺了60页左右

是吗？哦哦好吧。

我是QA刘

1949stone 发表于 2021-10-29 09:47
去看了下，不是完整版本，大约缺了60页左右

你通过一下我的好友申请，或者咱们用邮箱私聊一下可以吗？

1949stone

我是QA刘 发表于 2021-10-29 09:48
是吗？哦哦好吧。

不知道是不是那个论坛就显示这么多页  我留言问一下  要是全的就好了  也希望是全本
谢谢您提供的的资讯

我是QA刘

1949stone 发表于 2021-10-29 09:55
不知道是不是那个论坛就显示这么多页  我留言问一下  要是全的就好了  也希望是全本
谢谢您提供的的资 ...

我这儿有全版的，咱们互换吧，正好我也缺几个指南。你查看下你的邮箱。