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

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Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Sunday, 17 March | 1300–1800 Monday, 18 March | 0730–1830 Tuesday, 19 March | 0700–1700 Exhibit Hall Hours Monday, 18 March | 1015–1815 Tuesday, 19 March |...
iSpeak Blog
North Bethesda, Maryland is a popular travel spot for the ample shopping destinations, fine dining options, rich history, and proximity to our nation’s capital, Washington, D.C. The state of Maryland itself holds many hidden gems for outdoor activities,...
iSpeak Blog
Two of the contributors for the ISPE Baseline Guide: Sterile Product Manufacturing Facilities, discuss the modern technologies and break down of regulatory guidelines that will greatly assist pharmaceutical professionals and their facility...
iSpeak Blog
The impact on current mutual commerce and regulatory recognition between the UK and other EU countries was and is still unclear. Pharma cannot afford to wait and see what the impact is on the release and distribution of Clinical Trial Material from the...
iSpeak Blog
It's been clear for several years that the FDA, as well as the Federal Trade Commission (FTC), are turning up the heat on homeopathic drug products. It culminated in December 2017 when the FDA published a draft guidance document for both FDA staff and...
iSpeak Blog
We provide a complete toolkit for you to easily host a successful event The Women in Pharma® toolkit is ready to help you host an event for your ISPE affiliate or chapter. Incredible events with thought-provoking topics have already been hosted across...
iSpeak Blog
Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering study medication directly to patient homes, also known as Direct-to-Patient or...
iSpeak Blog
Conference Essentials Conference AgendaTravel Tips Registration and Information Hours Thursday, 7 February | 0700–1800 Friday, 8 February | 0700–1430 Exhibit Hall Hours Thursday, 7 February | 1015–1815 Friday, 8 February | 1030–1430 2019 ISPE...
iSpeak Blog
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10-11 December 2018 in Huntington Beach, California, featured a broad emphasis on both new scientific developments and the perspective of regulators in assessing those developments. The interaction of the pharma industry and regulators is...
iSpeak Blog
FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR...
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...

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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...