Newsletter | March 24, 2020

03.24.20 -- Understanding 2019 FDA Enforcement Trends -- And What They Mean For 2020

Featured Editorial
Understanding 2019 FDA Enforcement Trends — And What They Mean For 2020
By Bethany Hills, partner, Morrison & Foerster LLP

The FDA conducted a total of 18,034 inspections in FY2019, of which 6,434 were inspections of biologics, medical devices, or drug companies. Those inspections resulted in the issuance of 15,015 warning letters, a slight increase over 2018. The FDA also increased its import alerts, publishing 98 in 2019. This corresponded with a decrease in injunctions and seizures, showing the FDA’s preference for earlier preventive measures over later involvement.

Harmonization Horrors: When Quality System Alignment Goes Wrong
By Allan Marinelli, Quality Validation 360 Inc.

This article is the first in a two-part series explaining how to successfully harmonize disparate quality systems when two companies merge. Here in Part 1, we will focus on what not to do when reconciling two quality systems, providing real-life examples — drawn from the author’s experiences — from each phase of quality management system (QMS) harmonization.

Industry Insights
USP <1207> Updates Leak Testing Recommendations For Pharma Companies
Article | By Hemi Sagi, Pfeiffer Vacuum Inc.

Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and, in some cases, prevent oxygen ingress or maintain subatmosphere headspace pressures.

Ultra-Low Temperature Freezers: A Guide To Proper Use And Preventive Maintenance
Article | By Adam Christensen, NuAire, Inc.

The following criteria will help a lab manager train users and maintenance staff on protocols to keep the ultra-low temperature (ULT) freezer running optimally and reliably for cell preservation.

How The Extrusion Process Impacts The Quality Of Blow/Fill/Seal Products
White Paper | By Frank Leo, Cardinal Health, Inc., Patrick Poisson, Cardinal Health, Inc, Colin S. Sinclair, Air Dispersions Ltd., and Alan Tallentire, Air Dispersions Ltd.

A collaborative study involving Cardinal Health, Inc. and Air Dispersions Ltd. has been carried out to further the understanding of the extrusion process and its impact upon the quality of blow/fill/seal product.

Purposeful Design And Development Of A Next-Generation Single-Use Bioprocess Film
Application Note | By Chor Sing Tan, GE Healthcare Life Sciences

Fortem film development is an important investment by GE Healthcare, as it helps meet the industry need for a fully characterized platform film across all bioprocessing applications with supply chain transparency as a focal point. 

The Hidden Costs Of Multiple-Vendor Contract Manufacturing
Article | B. Braun OEM Division

When it comes to outsourcing in medical device manufacturing, companies are faced with the decision to either use a selection of unrelated service providers or a single-source contract manufacturer that can handle every step of the process. While there are benefits to piecing together a group of discrete resources, there could be unintended consequences that could delay the project timeline, increase costs, and lower finished quality, in addition to creating undue workloads and stress for the internal project team. This article discusses these consequences and presents the advantages of working with a single-source contract manufacturer.

Create Brand Sustainability With Softgel Technology
Article | Thermo Fisher Scientific

Keeping an eye on some emerging trends that are shaping society and the pharmaceutical industry can help you meet diverse consumer preferences and potentially extend product life cycles.

Delivering Flexibility Without Complexity
Article | Automated Systems of Tacoma, Inc.

Next-generation drug products are more targeted and patient-specific by nature, causing batch sizes to be much smaller. This paradigm shift paves the way for more flexible manufacturing solutions.

In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers
Application Note | LIGHTHOUSE Instruments

Using a high-sensitivity detection technique known as frequency modulation spectroscopy (FMS), LIGHTHOUSE rapid nondestructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid nondestructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.

An Innovative Solution To Flexibly Meet Unique Primary Packaging Requirements
Case Study | Catalent

A customer enlisted Catalent to support their child-resistant blister packaging requirements for a global Phase 3 study. A flexible design was created with an integrated blister card that could also support larger study requirements of 1.9 million monthly dosing cards. Through customized commercial blistering equipment a solution was provided that would accommodate the customer’s growing demands for clinical supplies.

Pfizer Installs Feeding Systems For Continuous Manufacturing Operations
Case Study | Coperion & Coperion K-Tron

Compact arrangement of pharmaceutical feeders supplied by Coperion K-Tron accurately deliver ingredients into the continuous mixing process, guaranteeing consistent and high-quality end products.

Efficient Track And Trace Solutions For International Pharmaceutical Company
Case Study | Wipotec-OCS

Serialization and aggregation solutions allows Swiss-based Acino Pharma to serve its international customers quickly and reliably.

Designing Engineering Controls For High-Potency Containment
Flow Sciences Inc.
CS3600 Case Scale
Mettler-Toledo Product Inspection
Advanced Analytics Solution
Seeq Corporation
Nondestructive Leak Detection And Package Integrity Testing: Veripac 310
PTI Packaging and Inspection Systems
Single-Use Bioprocess Containers
Thermo Fisher Scientific Bioproduction
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