Newsletter | August 6, 2019

08.06.19 -- How To Prepare For An FDA Inspection

Featured Editorial
How To Prepare For An FDA Inspection
By Mark Durivage, Quality Systems Compliance LLC

An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.

Next Steps For Serialization In The Pharma Supply Chain
By David Colombo, Valerie Eng, and Sarath Ramakrishnan, KPMG

Considering the progress the industry has made to date, organizations now have the opportunity to incorporate serialization into existing processes.

Industry Insights
Managing Demand Uncertainty In Biologics Production
White Paper | By Stephen Lam and John Ward, Thermo Fisher Scientific

How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
White Paper | By Andy Bailey, ViruSure GmbH

There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

Containment: Top Industry Methods And Challenges
White Paper | By Malcolm Cunningham, ChargePoint Technology

Which methods are most prominent in the pharmaceutical containment industry today, and what key challenges are pharmaceutical businesses facing?

The Benefits Of Virtualization Training For Automation Systems
White Paper | By Vladimir Pöyhönen, Elomatic

Automation companies need to keep up with the changing world. Virtualization expertise and specialization delivers far superior benefits compared with traditional approaches.

Fluid Bed Granulation And Melt Granulation In Pharma Manufacturing
White Paper | By Brian C. Anderson, AbbVie

Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.

Recommended Mixing Equipment For Pharmaceutical Gels
Application Note | By Christine Banaszek, Charles Ross and Son Company

A majority of pharmaceutical gels are shear-thinning semi-solids prepared by dispersing hydrophilic polymers into an aqueous vehicle. Proper mixing requires a good balance between agitation and shear.

5 Must-Haves In A Contract Packaging Partner
Article | Ropack Pharma Solutions

A contract packaging partner should function as an extension of the pharma’s organization, so careful consideration should be devoted to initiating this relationship. 

Serialization: A Road Map To Compliance
Article | Wipotec-OCS

Still looking for a serialization solution? In this case study, one contract packaging company took a different mindset and embraced the benefits of track-and-trace capability.   

Solid Dose Manufacturer Installs Serialization Efforts For Compliance
Case Study | Mettler-Toledo Product Inspection

Artesan Pharma demonstrates how an effective program of serialization, i.e., the traceability of medicines, can successfully be put into practice in today's pharmaceutical industry.


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