July / August 2020

Figure 1: Batch simulation using MVDA
Technical
Continued Process Verification in Stages 1–3

Continued process verification (CPV) as defined in the US FDA process validation guideline1 helps bring quality management and compliance in the pharmaceutical industry to the next level, but it has been challenging to...

  • 1US Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” 2011. https://www.fda.gov/media/71021/download
Reporting categories for changes in the drug substance (DS) and drug product (DP) process and analytical methods per FDA guidance [
Features
Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12

The latest ICH guideline, ICH Q12,1

  • 1International 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.
Figure 1: Dry block instruments for calibration to 55°C (left) and 75°C
Technical
Lyophilizer Instrumentation Calibration: Principles & 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. Recently, focused attention has been given to control and monitoring instrumentation for lyophilization.

Article
InTouch
ISPE Briefs: ISPE Special Interest Group for Cybersecurity

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.

The Untapped Potential of AI &  Automation in Pharmacovigilance
The Untapped Potential of AI &  Automation in Pharmacovigilance

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).1

  • 1US Food and Drug Administration. “FDA Adverse Events Reporting System (FAERS) Public Dashboard: Data as of December 31, 2019.”...
Achieving Vertical & Horizontal Integration in Pharma 4.0™
Features
Achieving Vertical & Horizontal Integration in Pharma 4.0™

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 supply chain and regulatory hubs throughout the entire technology stack. With horizontal...

How Vaccines Are Developed
Special Reports
How Vaccines Are Developed

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 world awaits a vaccine for the coronavirus, manufacturers face unprecedented pressure to respond...