Features
– Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing importance of data integrity for companies throughout the global GMP-regulated industry. This is especially true during health authority inspections. 2 , 3 , 4 Pharmaceuticals, biotech, and API manufacturers—as well as contract manufacturing organizations (CMOs) and contract laboratories—have been “in the trenches,” addressing improvements to strengthen data integrity and data management over the

Latest Articles

Technical
This article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The first section is a nontechnical summary of blockchain’s features, including a description of what it is (and what it is not). This sets the context for the next section,...
InTouch
ISPE has released three new Guidance Documents: Good Practice Guide: Single-Use Technology provides a road map for efficient implementation of single-use technology (SUT) with minimum disruptions to existing operations. From this Guide, users will learn...
Insights
Across industries, the trend is toward speed to market. - Whether it’s meeting consumer expectations for instant service or being the first to bring an innovation to shelves, companies have plenty of incentives to make products and services available faster.
Insights
Maritime discipline took the Boston Area Chapter President from a trawler to the boardroom. - It might seem odd to connect commercial fishing to the study of chemical engineering— and perhaps even more unlikely to connect commercial fishing to a career in the biopharmaceutical industry. But for...
Insights
Happy 2019! The last time I saw many of you was at the ISPE 2018 Annual Meeting & Expo in Philadelphia, where I started my tenure as the ISPE International Young Professionals Chair.
Insights
Over 2,000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo on 4–7 November. Highlights below show the many ways that presenters captured the conference theme of “Vision to Reality”: in strides against disease, ISPE’s advancements over the last...
Insights
On sitting down to write my first Chair’s column, I reflected on the events at our Annual Meeting & Expo in November. First, I want to commend the entire ISPE organization, and offer particular thanks to the 2018 Annual Meeting planning committee, for...
iSpeak Blog
Clinical trials becoming more complex and protocols are more demanding than ever. Long-term participation/commitment and frequent travel to investigator sites is a critical element for patient to decide if they want/can participate in a clinical...
Insights
JSYK: JUST SO YOU KNOW Info from this issue 50% Percentage of FDA Warning Letters that cite data integrity issues, 2017–Q1 2018 Data Integrity 40% - 50% RFT error rate for paper-based laboratory records 15% - 25% How much...
iSpeak Blog
As we approach the end of this year, we want to thank each of you—members, volunteers, leaders, and staff. We appreciate your great work, commitment, and dedication, which have been integral to ISPE’s progress and growth. In 2018, we supported Women in...
iSpeak Blog
2018 ISPE Biopharmaceutical Manufacturing Conference on 10-12 December in Huntington Beach, California, provided information about the future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into...
iSpeak Blog
2018 ISPE Europe Aseptic Conference Recap More than 200 attendees from manufacturers and key suppliers attended ISPE’s first European conference on aseptic manufacturing in the old capital of the Austrian Hungarian Monarchy Capital, Vienna. Austria is a...
iSpeak Blog
Many reasons to celebrate In the last week of November, the inaugural ISPE Europe Aseptic Conference took place in Vienna, Austria. With its emphasis on innovation in aseptic processing with focus on new regulation and pharma 4.0, this conference drew...
iSpeak Blog
As the end of the year approaches, many people are commenting how quickly this year has passed. This time of the year is when we typically reflect on our accomplishments and start strategizing next year’s goals. Taking proactive actions for our own...
iSpeak Blog
Student Poster Competition Undergraduate Winner The 2018 ISPE Annual Meeting & Expo completely exceeded my expectations in all aspects from the: Lessons I couldn’t have learned anywhere else, What-I-thought-was-impossible networks I...
iSpeak Blog
The growth of single-use technology (SUT) has revolutionized the bioprocess industry. The implementation of single-use technology (SUT) has typically been a trial and error exercise for the end users. A publication that provides a road map for...
iSpeak Blog
The 2018 ISPE Annual Meeting & Expo took place in Philadelphia this year. Philadelphia, the city with the oldest square mile in United States, has a lot to offer. I have spent the last twenty years of my life here, so I am speaking from experience....
iSpeak Blog
Biotech has a huge impact on our world. Biotech innovations provide novel treatments to cure diseases such as cancer and Alzheimer’s syndrome. Biotech brings new, sustainable products to the market. Biotech companies already conquer the world’s beef and...
iSpeak Blog
Regulators from three global agencies—US FDA, MHRA, and Brazil’s ANVISA—discussed how their agencies are addressing emerging therapies during the “Global Regulatory Town Hall” on 6 November at the 2018 ISPE Annual Meeting & Expo. “Precision medicine...
iSpeak Blog
There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development...
iSpeak Blog
Each year during the ISPE Annual Meeting & Expo, the ISPE International Honor Awards Committee acknowledges exceptional efforts, recognizing individual volunteers, affiliates and chapters, students, the company of the year, and the Facility of the Year...

Featured Articles

Features
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...
Features
The 2018 ISPE Quality Manufacturing Conference , held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus from both industry and regulators on this critical element of assuring product quality and patient...
Features
Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing importance of data integrity for companies throughout the global GMP-regulated industry. This is especially true during health authority inspections. 2 , 3 , 4 Pharmaceuticals, biotech, and API...
InTouch
Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1,2 Jokura et...
Features
Janssen is in the midst of a multimillion-dollar expansion project at the company’s Ringaskiddy, County Cork, manufacturing facility in Ireland. The 19,100-square-meter project is expected to significantly increase Janssen’s global manufacturing capacity for producing biologic medicines for...
Features
Our May-June cover story on the rise of biopharmaceutical manufacturing in Asia noted that “Biopharmaceuticals are booming … buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support.” 1 While that report focused principally on China, Indonesia,...
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.
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.

In This Issue

Features
Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing importance of data integrity for companies throughout the global GMP-regulated industry. This is especially true during health authority inspections. 2 , 3 , 4 Pharmaceuticals, biotech, and API...