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Release of 2nd Edition ISPE Baseline Guide 5 for Commissioning and Qualification

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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Download the Whitepaper: Power of Design Review

By Chip Bennett, May 30, 2019

Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and equipment. But what is Design Review? Why is Design Review underutilized in CQV projects? What are the risks of not performing Design Review? And more importantly, aside from regulatory expectations, what are the benefits of performing Design Review?

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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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The Top 2 Elements of FAT Planning

By Keith Weseli, December 13, 2018

 

Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the overall verification process.

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Are paper batch records slowing you down?

By Michael Morrison, November 13, 2018

How are batches managed?

 

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AAV Vector Production

By Robert Ossig, September 4, 2018

Overview

Until about 2016, the majority of vectors used in gene therapy were Adenovirus and Retrovirus vectors.  In recent years, a change toward Lentivirus and Adeno-associated virus (AAV) vectors has occurred.  This is reflected when looking at the numbers in current clinical trials underway in the gene therapy field.

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Maximizing the Impact of Factory Acceptance Testing

By Keith Weseli, September 19, 2017

 

Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the overall verification process.

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How to Understand ASTM E2500