Newsletter | March 19, 2020

03.19.20 -- A SMART Approach To CAPA Effectiveness Checks

Featured Editorial
A SMART Approach To CAPA Effectiveness Checks
By Mark Durivage, Quality Systems Compliance LLC

Many times, corrective and preventive actions (CAPAs) fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. This article will look at using the SMART (specific, measurable, achievable, relevant, and time-bound) methodology for use in developing a CAPA verification of effectiveness plan.

The 4 Stages Of Drug Delivery Device Evolution: An Inhaler Case Study
By Valerie Phillips, Michael Noble, and Mark Humphries, PA Consulting

To illustrate how delivery device development is evolving in practice, we will use the example of respiratory inhalers. This is a well-established treatment modality, with mature technology solutions available, but one where you can envisage a number of future changes enabled by technology. 

Industry Insights
Is Your CMO Ready For Serialization And Aggregation?
White Paper | By Lloyd Mager, AbbVie

While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?

Key Concepts Driving The Future Of Single-Use In Biopharma Production
White Paper | By Matthew Olsen, Sartorius Stedim Biotech

This article discusses four topics related to single-use bioprocessing that are commonly cited by end users as amenable to future development. 

A Bridge Over Troubled Water: The Journey To Serialization Compliance
Article | By Nicolas Girard, Ropack Pharma Solutions, and Graham Clark, TraceLink

This regulation from the FDA outlined serialization and traceability requirements spread over the course of 10 years with preparation for each phase accumulating into a potentially high overall price tag.

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

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

What Cleanroom Build Method Is Best For You?
Application Note | By Ralph Melfi, AES Clean Technology, Inc.

Your future cleanroom is a critical asset; it is not just another construction project. The investment you make in the cleanroom facility is significant, and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

Choose Between Infrared And Thermal Conductivity Co2 Sensors In Incubators
Article | NuAire, Inc.

This paper compares the two main technologies for measuring CO2 — infrared (IR) and thermal conductivity — and examines which technology might be best for a given laboratory.

Rapid Large-Scale Mixing Of Clumped Powder In Pharma Manufacturing
Application Note | ILC Dover

For operations where low shear and high product integrity are required, traditional technologies pose a risk to the quality of the final product.

Mass Transfer Of Single-Use Fermenters To Stirred Glass Bioreactors
Application Note | Thermo Fisher Scientific

Performance demands in industrial microbiology have limited conversion of traditional fermentation processes into single-use systems. To address microbial application needs, single-use fermenters are meeting the requirements of microbial fermentation instead of being modified from a cell culture bioreactor.

Closed And Semiautomated Processing Of CAR T Cells
Application Note | GE Healthcare Life Sciences

This application note describes the details of a robust CAR T-cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.

Total Transportation Management Saves Company $10.2 Million
Case Study | Thermo Fisher Scientific

A leading multinational pharmaceutical company approached Fisher Clinical Services with an extensive clinical trial pipeline and the need to achieve a comprehensive, fully managed transportation strategy. Learn more about our outsourced transportation option that delivered tangible results.

Strategies For Optimizing Upstream Processes Cell Culture
Poster | Thermo Fisher Scientific

The cell culture process is crucial for maximizing the production of biologics and vaccines, optimizing product quality attributes, minimizing impurities, and simplifying operations.

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