Newsletter | November 21, 2019

11.21.19 -- Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)

Featured Editorial
Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)
By Herman F. Bozenhardt and Erich H. Bozenhardt

There are many ways to tackle pharmaceutical facility design, engineering, building, and production, and each plant has its own methods and culture. However, there are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events or activities that we have seen and, while they are amusing or baffling, they reveal the flaws in our industry.

CDMO Selection: How To Kick Off A Game-Winning Project
By Ray Sison, xCell Strategic Consulting, LLC

This article explores the execution phase of outsourcing with a focus on the context and planning of the kickoff meeting. At this meeting, the handoff from the existing procurement team to the operations team will require close attention.

Industry Insights
The Cost Savings Of Blow-Fill-Seal: More Than A Million Reasons To Switch
Article | By Andy Goll, Weiler Engineering, Inc.

Despite the benefits of blow/fill/seal (B/F/S) over glass, some pharmaceutical companies refuse to make the switch because of a number of objections.

Cell Therapy Manufacturing: The Supply Chain Challenge
Article | By Christina Bennett, GE Healthcare Life Sciences

Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Two industry experts detail strategies to meet supply chain challenges.

Quality Assurance And Your CDMO
Article | By Chantale G. Robles, Grifols Recombinant Protein CDMO Services

While the end result of regulatory compliance with quality standards is binary, the processes employed to get there do not need to be rigid, prescriptive, inefficient, and expensive. Learn how an innovative approach drives lower costs and higher efficiencies.

Help Keep Pharmaceuticals Safe: Metal Detection Overview And Guidelines
White Paper | Thermo Scientific Product Inspection

Using metal detection as a means of identifying foreign object contamination has been prevalent in the food industry for decades. Although metal detection has also been in use to identify the presence of ferrous, nonferrous, or stainless-steel contaminants throughout the past 40 years in the pharmaceutical industry, it has not been widespread.

Container Closure Integrity Testing Of IV Bags
Application Note | Advanced Test Concepts (ATC) by Pfeiffer Vacuum

As a means of ensuring the safety of sterile products, the FDA and the United States Pharmacopeia have provided strict guidelines for the testing of container closure systems.

Serialization And Aggregation Of Drug Products
Case Study | Wipotec-OCS

A Pharma company finds a solution that allows the operator to conveniently assign the units from a lower packaging level to a higher level and, in this way, to set up the hierarchical relationships in the database.

The Basics Of Biosafety Cabinets
E-Book | NuAire, Inc.

The role of a biosafety cabinet, while critical, might seem passive. A biosafety cabinet (BSC) does not perform any one direct function, but rather it prevents adverse conditions from occurring.

Lyo Chamber Moisture Mapping
Case Study | Lighthouse Instruments

Rapid nondestructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.

Improve Data Integrity And Quality For Life Sciences
Infographic | Dassault Systemes Americas

Improve data integrity and quality, ensure IP protection, increase efficiency and collaboration, and enable faster and better decision making.

Life Science Training Courses
Writing Effective 483 And Warning Letter Responses


Establishing Appropriate Quality Metrics

Nov. 21, 2019 | 1:00 PM EST

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