July / August 2020

InTouch
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
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...
Features
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....
Special Reports
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...
Technical
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...
InTouch
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.
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...
Features
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...
Special Reports
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...
Special Reports
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....