Features
– Risk management is pervasive throughout the biopharmaceutical industry. It is an important factor during the implementation of new equipment or procedures into an operation. Likewise, risk management is also key when assessing the impact of changes. When doing a root cause analysis, evaluation of the risks becomes central to define the potential solutions to the problem analyzed and to eliminate the contributing cause.

Featured Articles

Special Reports
The 2019 ISPE Annual Meeting & Expo will be held 27–30 October in Las Vegas, Nevada. The theme is “Modernize. Globalize. Transform.” Michael L. Rutherford, Program Committee Chair and Board Ambassador for ISPE, and Executive Director for Computer Systems Quality and Data Integrity at Syneos Health,...
Features
On 5 June 2018, a plenary session entitled ”Patient-Centric Specification” (PCS) was held at the 2018 ISPE Quality Manufacturing Conference in Arlington, Virginia. More than 160 professionals from worldwide innovator and generic pharmaceutical companies, academia, and regulatory agencies attended....
Features
The Pharma 4.0 Special Interest Group is focusing on key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. These technologies include digital twins, augmented reality, artificial intelligence, big data and analytics, mobiles, cloud, advanced...
Features
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to...
Features
To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161...
Features
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the...
Features
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into the achievements that are already underway....
Features
This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs). As patients have become more involved and informed in their healthcare choices, the “voice of the patient” has been increasingly incorporated...
Features
It is the duty of the government to improve access to safe, effective, and quality medicines for its constituents. Various approaches are taken by different countries to achieve this; for the Philippines, the approach is through the active promotion of...
Features
In Japan, off-patented drugs are not always converted to generic drugs but may remain on the drug list as off-patented-drug products. These are customarily classified into three groups: patented drugs; off-patented drugs (“long-listed drugs”); and...
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.

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Latest Articles

iSpeak Blog
Featured in this edition of ISpeak Reading Roundup, are the top blog posts from August 2019. Discover key insights for data integrity, manufacturing excellence, innovative validation practices, and more for what the pharmaceutical industry was reading...
iSpeak Blog
Featured in this edition of ISpeak Reading Roundup, are the top blog posts from August 2019. Discover key insights for data integrity, manufacturing excellence, innovative validation practices, and more for what the pharmaceutical industry was reading...
iSpeak Blog
In 1988, the Oldsmobile automobile company attempted to rebrand themselves to appeal to a new generation of car buyers by introducing a marketing campaign that distanced itself from everything that it had stood for up to that point. The tagline line was...
iSpeak Blog
Please join me at the 2019 ISPE Global Pharmaceutical Regulatory Summit, being held at the Bethesda North Marriott in Bethesda, Maryland December 5-6, 2019. The theme for this year’s summit is “Igniting Innovation in Development & Quality During...
iSpeak Blog
Edwin L. Harmon, III Vice President of Engineering, Facilities and Validation LSNE - Contract Manufacturing Organization Edwin Harmon, Vice President of...
iSpeak Blog
Design and construction of facilities and equipment using modern day information technology is common in today’s project execution. Comprehensive 3D modelling, component databases, scheduling and planning are all common place, almost to the point that...
InTouch
Newest WIP Initiative: The WIP Mentor Circle Program1 Learn More 1. ISPE Women in Pharma®. https://ispe.org/women-pharma
InTouch
The second day of the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, 18–20 June, kicked off with the Women in Pharma® Balance for Better in Biopharmaceutical Manufacturing breakfast session. Session leader Katherine Leitch, Director of Technical Services, External Manufacturing,...
Special Reports
This special section looks at what’s coming up at the 2019 ISPE Annual Meeting . It also features the voices of first-year Travel Grant recipients who attended last year’s Annual Meeting courtesy of the ISPE Foundation and offers a look at the 2019 Facility of the Year Award (FOYA) category winners...
Special Reports
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program . This year’s nine category winners and honorable mentions range from industry giants with hundreds of years of history to relatively new enterprises....
Special Reports
The ISPE Foundation ® awarded 14 Student Travel Grants to bring 14 students to the 2018 ISPE Annual Meeting & Expo . Investing in the next generation of pharmaceutical engineers is a goal of the Foundation, which was formed in 2018.
Insights
In his 17 years as a member of the ISPE United Kingdom Affiliate , Jon Youles has worn many hats, including Editor for the newsletter, Chair of the Southern region’s committee, and Secretary and Vice Chair of the Affiliate. Now, as Chair of the Affiliate, he leads an engaged membership that is...
Insights
In a world dominated by social media and online profiles, the art of getting to know someone has been transformed. So, in this age, when you can connect with someone by “swiping right” on a dating app, how do you build a professional network? Face-to-face interactions remain a great starting point....
Insights
As I write my last Chairman column for Pharmaceutical Engineering, I reflect on what has happened over the past year globally and within ISPE. The pace of change in the industry has accelerated and will continue to accelerate with new technologies and business models being deployed.
iSpeak Blog
The Asia Pacific (APAC) region is diverse in terms of its demographics. From the developed countries such as Japan, South Korea, Taiwan, Singapore, and Australia to emerging economy countries such as Thailand, Indonesia, Malaysia, Vietnam, Bangladesh,...
Technical
Newer container closure integrity (CCI) test methods are more accurate and reliable than longtime industry standards. Transitioning to include deterministic testing alongside probabilistic methods may seem daunting at first, but it is in the industry’s best interest.
Technical
Despite introducing modern analytical technology to assess blend uniformity, many companies are still using traditional blend sampling thieves and wet chemistry to assess blend homogeneity. The use of statistically based sampling plans allows variance component analysis to be conducted on both...
iSpeak Blog
Extremely Competent. Hardworking. Strong Leadership Skills. Results Oriented. Proven Track Record. Are these qualities all that it takes to progress your career? Perhaps something more is needed? Having a sponsor can make all the difference – and propel...

In This Issue

Features
Risk management is pervasive throughout the biopharmaceutical industry. It is an important factor during the implementation of new equipment or procedures into an operation. Likewise, risk management is also key when assessing the impact of changes. When doing a root cause analysis, evaluation of...