May / June 2021

Pharmaceutical Engineering May / June 2021 Cover

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IT Services: Applying Good IT Practice and Automation

Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiative—which is promoting a risk-based, product quality, and patient-centric approach to computerized systems assurance—as well as the GAMP® reexamination of approaches to IT infrastructure control and compliance.

Best Practices for Deploying Real-World Evidence Solutions

Feature: Real-world evidence (RWE) is clinical evidence regarding the usage and potential bene ts or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery. RWE helps healthcare companies better understand and establish stronger evidence of products’ performance, clinical value, and cost-effectiveness outside the controlled environment of clinical trials. Outcome-based studies are increasingly depending on RWD and RWE to speed up drug development and approvals, and ultimately reduce development costs.

Happy 30th Anniversary to the GAMP® Community of Practice!

Feature: In 2021, the ISPE GAMP® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient safety, product quality, and data integrity.

Analyzing System Performance through Process Instrumentation Data

Technical: What if the reliability of a system could be improved by accessing the standard data provided with modern process instrumentation? These data, accessed from existing instrumentation, can be used to analyze the fitness of processes, equipment, and instruments; better understand processes; support discrepancy investigations; and provide a data-driven basis for the timing of maintenance and calibration. This article covers a few particularly illustrative examples in detail.

In This Issue

Features
This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiativeUS Food and Drug Administration Center for Devices...
Insights
I used to think “home detention” was no punishment at all, but this last year has dramatically changed my thinking. Despite working from home for over a year, my house is a wreck! Like many of you, I feel busier than ever, despite not traveling and not driving to and from work. Disruption used to...
Insights
This year’s Women in Pharma® (WIP) theme of “Fueling the Fire” harnesses the energy and passion that drive women to achieve career advancement, personal growth, and satisfaction. The 3 March webinar focused on the Diversity & Inclusion theme, where we discussed what we as leaders can do to drive...
Insights
2020 was a year for finding new ways of working for the entire ISPE Emerging Leaders (EL) community. In February, Emerging Leaders stepped up the challenge by holding the first fully virtual International Hackathon. With over 22 countries represented, the Hackathon required the participants to...
Features
Real-world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery.US Food and Drug Administration. “Use of Real-World Evidence to...
Features
In 2021, the ISPE GAMP® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient safety, product quality, and data integrity.
Features
Cloud computing can be described as networked access and utilization of configurable computing resources such as data and information storage, processing capabilities, applications, and other services on computerized systems provided and/or maintained by a remote organization. As life sciences...
Features
This second of a two-part series explores digital transformation and digitalization in the biopharmaceutical industry with information about how data science enables digitalization along the product life cycle. (Part 1 was published in the March-April 2021 issue of Pharmaceutical...
InTouch
ISPE Emerging Leaders (ELs) held the first fully virtual International Hackathon in February. Fifty-one participants from over 22 countries encountered real-life challenges with working remotely and across time zones. Innovation was key to generating solutions to the problem statement provided by...
Technical
What if the reliability of a system could be improved by accessing the standard data provided with modern process instrumentation? These data, accessed from existing instrumentation, can be used to analyze the fitness of processes, equipment, and instruments; better understand processes; support...
Technical
One of the goals of the cleaning validation design phase is to define critical process parameters (inputs) and acceptance criteria (outputs) of the cleaning process. This article explores the selection of a master soil as part of the cleaning validation design phase for automated parts washers. The...
Online Exclusives
The 30th ISPE Aseptic Conference culminated in the interactive regulatory panel, which offered attendees the unique opportunity to ask questions directly to the regulators.