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You Can't Distance From Quality

By David Shenberger, June 15, 2020

As an essential business, which must continue functioning in the current global environment, Pharmaceutical Manufacturing companies face unique challenges. Pharmaceutical Manufacturing relies on operating in a controlled state, which stems from Quality Systems in six significant areas. With the current COVID-19 outbreak, this may require adjustments to the way the plant operates typically. Decisions require a scientifically sound process.

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Quick Glance: ICH Q10 Question Solved?

By John Henchion, February 13, 2020

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Release of 2nd Edition ISPE Baseline Guide 5 for C&Q

By Steve Wisniewski, July 16, 2019

Intro

ISPE has just released the second edition of Baseline Guide 5 for Commissioning and Qualification (C&Q) The objective of the 2019 C&Q Baseline Guide revision is to define and explain a simplified risk-based C&Q process in a single guide that meets present-day standards and provide focus to ensure a compliant, efficient, and cost-effective approach.  The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment.  It supersedes the 2001 publication and the two 2011 Guides covering Quality Risk Management/ASTM E2500 based approaches.

The new Guide provides an improved QRM C&Q process flow and recommended implementation practices with practical examples taken from the industry.

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C&Q Benchmarking: Process and State of the Industry

By Nathan Temple, May 17, 2019

Risk-based approaches to commissioning and qualification (C&Q) is a common standard for site and project plans. What does that mean and why is there so much implementation variability across the industry? Our CQV benchmark initiative is focused on:

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Facilitation is the Key to Successful FMEAs

By Robert Smith, October 19, 2017

The Failure Modes and Effects Analysis (FMEA) is a versatile risk management tool that has been around for several decades, first used by the US Armed Forces in 1949. It started gaining popularity in the 1960’s with its use in the aerospace industry during the Apollo missions. FMEA has been called the “swiss army knife” of risk management. FMEA is focused on problem prevention, rather than problem solving. It is used to identify the factors that can lead to failure and recommend mitigation strategies to prevent failures or detect the early onset of failures.

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How to Understand ASTM E2500