July / August 2020

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2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology

Cover: For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and has been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its key results, which were first shared at the 2020 ISPE Aseptic Conference.

Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12

Feature: The latest ICH guideline, ICH Q12, introduces regulatory mechanisms, such as established conditions (ECs), to simplify and expedite postapproval product variations and enable continual product improvement. As illustrated by this case study for a small molecule product, the appropriate use of established conditions can successfully narrow the technical and regulatory gaps that limited the realization of flexible regulatory approaches promised by the application of Quality by Design principles.

Special Report: COVID-19 Impact

Special Report:

Pharmaceutical Engineering® COVID-19 Impact Survey: How the Industry Is Responding
Engage with Health Authorities to Mitigate & Prevent Drug Shortages
Pandemic Preparedness & Business Continuity
How Vaccines Are Developed

Process Technology

TECHNICAL: Lyophilizer Instrument Calibration: Principles and Practices Historically, the pharmaceutical industry’s focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. A greater understanding of the science and technology of lyophilization drives improvements in calibration, which leads to better process control and increased confidence in achieving product quality.

In This Issue

Features

2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology

1 July 2020

For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its...

Insights

Message from the Chair: The Next Normal - Workforce of the Future

1 July 2020

Since January, nothing has been normal. Nothing, especially when we try to compare it to anything we have experienced in the recent past. So how do we begin to move forward as the efforts of both the public and private sectors combine to offset the advance of the impact to businesses due to...

Insights

Women in Pharma® Editorial: Virtual Connections

1 July 2020

How is your calendar looking these days? As I write this, we have all been living a bit differently today than we were one year ago. I’ll bet you have seen an increase in webinars, virtual trainings, and video conference calls, and likely having far fewer face-to-face interactions.

Insights

Young Professional Editorial: Career Development - Goes On

1 July 2020

I wanted to take a break from my usual column and highlight a few Young Professionals (YPs) around the world. These individuals have not let COVID-19, or anything else, get in the way of their career development. Each joined ISPE at a different time in their career and is using the ISPE Communities...

Features

Regulatory Panel Session: Explores Key Aseptic Topics

1 July 2020

The 2020 ISPE Aseptic Conference was capped off on Tuesday, 3 March, by the Interactive Regulatory Panel session, which has been a popular feature of the conference during its 29 years. The session featured a panel of seven US FDA regulators who addressed a long and varied list of questions about...

Special Reports

Pharmaceutical Engineering® COVID-19 Impact Survey: How the Industry Is Responding

1 July 2020

As the COVID-19 pandemic continues, pharmaceutical companies are taking steps to address the short-term consequences while also preparing for what may be the long-term effects for the world, individual nations, and the pharmaceutical industry. In late April and early May, Pharmaceutical...

Special Reports

Engage with Health Authorities to Mitigate & Prevent Drug Shortages

1 July 2020

When faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and event-specific actions of health authorities may not always be sufficient to prevent shortages of critical medical products. However, early, transparent...

Special Reports

Pandemic Preparedness & Business Continuity

1 July 2020

This article updates a 2006 Pharmaceutical Engineering® Online Exclusive article titled “Avian Flu—Is My Company Prepared?” by Wendy Haines and Martin Rock.Haines, W., and M. Rock. “Avian Flu—Is My Company Prepared?” Pharmaceutical Engineering 26, no. 6 (November-December 2006): Online Exclusive....

Special Reports

How Vaccines Are Developed

1 July 2020

Vaccine development is an intricate undertaking, which may involve numerous challenges from the initial process of identifying an antigen to the final steps of delivering and administering the licensed product. The COVID-19 pandemic has put a spotlight on the science of vaccine development. As the...

Features

Achieving Vertical & Horizontal Integration in Pharma 4.0™

1 July 2020

Recent projects on serialization and track and trace help illustrate the concepts of vertical and horizontal integration. With vertical integration, the unique product identification information (serial number, lot, etc.) used by sensors and printers on the packaging lines is made accessible to the...

The Untapped Potential of AI & Automation in Pharmacovigilance

1 July 2020

Between 2009 and 2019, the number of adverse events (AEs) for drugs and therapeutic biologic products recorded by the US FDA Adverse Event Reporting System (FAERS) increased more than 300%, from 490,032 to 2.19 million cases (as of 31 December 2019).US Food and Drug Administration. “FDA Adverse...

InTouch

ISPE Briefs: ISPE Special Interest Group for Cybersecurity

1 July 2020

ISPE has a new special interest group (SIG) to work on IT cybersecurity. The Special Interest Group was formed under GAMP®. A conversation with Jason Young of Silver Bullet Security, who heads the new group, provides details about the Special Interest Group.

Technical

Continued Process Verification in Stages 1–3

1 July 2020

Continued process verification (CPV) as defined in the US FDA process validation guidelineUS Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” 2011. https://www.fda.gov/media/71021/download helps bring quality management and compliance in...

InTouch

Coronavirus Collaboration

1 July 2020

Industry interaction is key to understand and cope with the challenges of life during the pandemic. Collaboration (of the social distancing variety) can help manufacturers, consultants, and other members to stay informed and to share information. ISPE...

Technical

Lyophilizer Instrumentation Calibration: Principles & Practices

1 July 2020

Historically, the pharmaceutical industry’s focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. Recently, focused attention has been given to control and monitoring instrumentation for...

Special Reports

Special Report COVID-19 Impact

1 July 2020

Pharmaceutical Engineering® COVID-19 Impact Survey: How the Industry is Responding to the Pandemic In late April and early May, Pharmaceutical Engineering surveyed over 50 ISPE members who hold leadership positions within the Society about the...

Features

Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12

1 July 2020

The latest ICH guideline, ICH Q12,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019....