September / October 2019

Pharmaceutical Engineering September / October 2019 Cover

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Risk Management in Single Use Technology

Cover: 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. This article expands on a chapter addressing risk management in single-use technology in the ISPE Good Practice Guide: Single-Use Technology.

Accelerated Pharmaceutical Product Development, Registration, Commercialization, and Life Cycle CMC Lessons, Part 2

Feature: This two-part series focuses on challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status. In this issue, Part 2 expands the discussion of considerations and themes introduced in Part 1 and presents several case studies of pharmaceutical products being approved using accelerated programs.

Patient-Centric Specification: Regulatory and Industry Progress

Feature: A plenary session entitled ”Patient-Centric Specification” (PCS) was held at the 2018 ISPE Quality Manufacturing Conference in Arlington, Virginia, to discuss the recent regulatory and industry progress on this topic. Attendees discussed the opportunities, challenges, and future directions for establishing PCSs.

2019 ISPE Annual Meeting & Expo

Special Section: 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 and honorable mentions.

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...
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....
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...
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.
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
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.
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....
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....
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...
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...
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,...
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,...
InTouch
Newest WIP Initiative: The WIP Mentor Circle Program1 Learn More 1. ISPE Women in Pharma®. https://ispe.org/women-pharma