Technical
An overview of pass-through boxes as they relate to the life sciences industry, defining their purpose, applications, and available options.
Downloads
The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. Jean-François Dulière, ISPE Comment Team Lead, breaks down the details on the developments.
Meet the Annex 1 Revisions
Cover: The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. New sections on scope, utilities, environmental monitoring, and process monitoring; a reorganized and restructured content for a more logical flow; and the introduction of QRM principles make the new and improved Annex 1 critically important for the pharmaceutical industry. Jean-François Dulière, ISPE Comment Team Lead, breaks down the details.
In-Line, Real-Time Powder Flow and Monitoring
Feature: Efficient powder handling and processing is essential for competitive drug manufacture, since most pharmaceuticals, especially oral solid dosage products, are in powder form at some point. While PAT for powder processes has advanced considerably over the last decade, the current analytical solution is suboptimal in some areas, especially related to continuous manufacture. Tim Freeman of Freeman Technology explains.
Quality Metrics
Special Report: A team of writers from the ISPE Quality Metrics Initiative team report on recent developments, including the proposed ISPE Advancing Pharmaceutical Quality program, an MOU between ISPE and PDA to exchange quality metrics and quality culture information, the development of a CAPA maturity pilot framework and a cross-functional subteam to evaluate and report on the planned FDA quality metrics portal
In This Issue
Features
The European Commission (EC) published its long-awaited revision draft of Annex 1.
Technical
The amount of data collected in a typical pharmaceutical manufacturing operation is staggering, yet research shows that much of this information is rarely used for anything more than compliance. New technologies such as big data, artificial intelligence, machine learning, and deep learning permit unprecedented analysis of realtime data and can even predict trends in processes and operations....
Technical
This article illustrates the importance of experimental conditions to evaluate analytical methods. Italicized text is used throughout the article to emphasize key points and illustrate formula variables.
Features
Innovative technology for in-line real-time powder flow monitoring based on drag force flow measurement offers great potential for efficient monitoring of powder-processing operations.
Features
Notes from the recent meeting of the European GMP/GDP Inspectors Working Group (IWG)
InTouch
Patient-Focused Harmonization Efforts in the Spotlight
InTouch
Highlights from the stories of the five Category Winners and two Honorable Mentions of this year's Facilities of the Year Awards (FOYA) showcase pharmaceutical industry achievements.
InTouch
This year's ISPE Annual Meeting & Expo will be held from 4 to 7 November in Philadelphia, Pennsylvania. The theme is "Vision to Reality: Delivering Next-Generation Therapies." The first keynote presentation, by Lars Fruergaard Jørgensen, President and CEO, Novo Nordisk A/S and Honorary Conference Chair, will address leadership in diabetes management and groundbreaking manufacturing...
Insights
ISPE's Board of Directors is working to refresh the Strategic Plan.
Special Reports
The ISPE Advancing Pharmaceutical Quality (APQ) team is developing a framework by which a company can assess its maturity in relation to quality culture, operational excellence, and ICH Q10 elements, using the CAPA system as the focus of the pilot.
Special Reports
ISPE Quality Culture Team members share key concepts represented in the Six Dimensions of Cultural Excellence framework.
Special Reports
The basic framework of the program is to "assess and aspire" quality maturity.
Insights
On 19 June, ISPE officially launched the ISPE Foundation. The philanthropic arm of ISPE "will enhance ISPE's ability to support its members and the pharmaceutical industry as they prepare to address new and evolving industry demands," according to Michael A. Arnold, ISPE Foundation Board Chair, and John E. Bournas, ISPE CEO and President.
Insights
Attending Large Conferences and Navigating Exhibitor Halls
Insights
I write my final "Message from the Chair" article full of a range of thoughts and emotions. Perhaps the best way to sum up my feelings is just to say, "Time flies when you're having fun."