Newsletter | March 5, 2020

03.05.20 -- U.S. Sites' Surprise Role In FDA's GMP Warning Letter Report

 
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  INTERPHEX 2020
 

April 28 to 30, 2020
Javits Center, NYC

For 41 years, INTERPHEX has proven to be the place to find all of the state-of-the-art solutions you need to cost-effectively develop and manufacture quality product. INTERPHEX is the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can "Experience Science through Commercialization."

Featured Editorial
U.S. Sites' Surprise Starring Role In FDA’s GMP Warning Letter Report
 
By Barbara Unger, Unger Consulting Inc.

Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, the depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

3 Building Blocks Of Organizational Agility For Pharma Manufacturing
By Hector M. Samper and Wolfram Mueller

In Part 2 of this series on pharma manufacturing we dig deeper into the details of the building blocks of an agile approach and the methods that can be used to achieve it.

Industry Insights
Industrial Atomic Force Microscopy Is Suddenly Accessible
Article | By Patrick O’Hara, Anton Paar USA

By offering industrial users streamlined operations, high accuracy, and powerful visualization, Tosca series AFMs have made commercial atomic force microscopy more accessible and useful than ever before.

Flow And Level Instrument Verification In Pharmaceuticals
Article | By Ravi Shankar, Endress+Hauser, Inc.

Read how continual internal diagnostics and in-situ verification capabilities lead to a better overall equipment effectiveness, resulting in less downtime and fewer unexpected shutdowns.

Choosing A CMO: Find The Best Match By Asking The Right Questions
White Paper | By Mike Fritschy, SMC Ltd.

When selecting a CMO it’s important to look at organizational alignment, senior leadership engagement, program management, commitment to projects large and small, and processes in place to manage risk. 

Avoiding HPAPI Contamination
White Paper | By Olindo Lazzaro and Max Brescia, AbbVie

Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes, and deploy appropriate containment strategies. 

Evaluating Real-Time Viability Detectors
White Paper | By Darrick Niccum, TSI Incorporated

Rapid microbiological methods have been around for years but have yet to make a significant impact on pharma manufacturing despite the advantages they offer in cost savings and process improvement.

Guide Clients Through Drug Development With Intelligent Collaboration
Q&A | A Q&A with JoyL Silva, Pfizer CentreOne Contract Manufacturing

This article is a recent discussion with the general manager of Pfizer CentreOne, regarding what it’s like to lead an embedded CDMO within one of the largest pharmaceutical companies.

Determining Performance Improvements In Quality By Design Plungers For Syringes In Autoinjector Systems
Poster | By A. Kim, et al, West Pharmaceutical Services, Inc.

This poster presents a one-year study examining performance with placebos of different viscosities (1, 8, 15 cps) in a laboratory configuration that replicates an autoinjector.

Pairing Data Connectivity And Automation Ease Tech Transfer And Scale-Up
White Paper | GE Healthcare Life Sciences

This article outlines how connectivity and a comprehensive automation solution can ease technology transfer and scaling from process development to final manufacturing scale.

3 Trends That Could Improve Air Cargo Shipping In Pharma Supply Chain
White Paper | Pelican BioThermal

There are three technology trends that could help mitigate airfreight logistics risks, reduce costs related to transportation issues and/or temperature excursions, and deliver high-quality drugs safely.

Guide To Track And Trace Technology
E-Book | Mettler-Toledo Product Inspection

The Track & Trace Guide provides a complete reference to track and trace technology for use in the pharmaceutical industry.

Why Are Lipid Formulations Commonly Used To Enhance Bioavailability?
Webinar | Thermo Fisher Scientific

A discussion on potential mechanisms of increased absorption with lipid formulations, screening tools used during the development of these formulations, scale up, and industrialization considerations. 

Events
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Online
February 12 to March 6, 2020

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