Newsletter | July 8, 2014

07.08.14 -- Roche's Genentech To Acquire Seragon Pharmaceuticals; The Training Component In Every 483

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» Guest Column
"Every 483 Observation Has A Training Component"
By Joanna Gallant, Joanna Gallant Training Associates
“Every 483 observation has a training component.” Truer words have never been spoken — I only wish it was me who said them. An FDA inspector I heard at a conference almost 15 years ago made this statement, and it forever changed how I look at 483 observations. I'll admit up front that I have a bias toward training — after all, it's what I do. Others don't necessarily share that bias, being that often training isn't done well, isn't timely or effective, or isn't always meaningful. I've heard the arguments and can even agree with some of them. But let's set that aside for now and look at what the inspector meant.
Featured Focus: QA/QC
Medicinal Sprays: How Do You Test For "Stickiness?"
By Eric Chiang and By Robert G. McGregor, Brookfield Engineering Laboratories, Inc.
Medicinal and pharmaceutical products that are applied by spraying have gained in popularity because they easily coat the targeted surface without need for further spreading action by the consumer. Oral and nasal sprays may actually work with greater rapidity, migrating quickly to the target area and producing a very desirable benefit for the patient in terms of faster relief. How do manufacturers know whether the spray will actually stick to the targeted surface once it arrives?
WHITE PAPER: How A Checkweigher Can Address Track And Trace Requirements For ePedigree Compliance
By Kevin Zarnick, Thermo Fisher Scientific
The U.S. Food and Drug Administration (FDA) issued the Prescription Drug Marketing Act of 1987 (PDMA), which was then modified by the Prescription Drug Amendments of 1992. Included was Section 503(e)(1)(A), which establishes the pedigree requirement for prescription drugs.
CASE STUDY: Innovative Valve Interfaces Ensure Customized Productivity In B. Braun LIFE Nutrition Plant
By Jens Voigtländer, Editor, Bürkert Werke GmbH
B. Braun Melsungen AG is one of the leading companies in the international pharmaceutical and medication sector. With an investment of 164 million Euros the company is currently building the LIFE Nutrition plant, one of the world's most modern production sites for innovative nutrition solutions, at the company headquarters in the North Hessian city of Melsungen.
DATASHEET: Packet Dispenser: APA-1500 Compatible With All Packaging Lines
By Multisorb Technologies
BROCHURE: Handheld Particle Counters With High-Resolution Display
» Inspection
CASE STUDY: Advanced Leak Test Methods
By Hemi Sagi, Director, ATC, Inc.
Before new technologies were available to directly measure very small leaks, most leak measurements were done indirectly. Direct mass leak flow measurement has many advantages.  It is independent of part volume or configuration, and it's not sensitive to temperature changes.
VIDEO: Container Closure Integrity Testing And Micro-Leak Detection Of Liquid Pharmaceuticals
SERVICE: Contract Metal Detection Services
» Critical Environments
WHITE PAPER: Effect Of Closure Composition And Processing Parameters On End Product Dryness Over Time
By A. Miller and J. Riter, SP Scientific
Residual moisture in elastomeric closures can cause degradation of lyophilized drug product. Prior to packaging the drug product, pharmaceutical manufacturers typically wash, steam sterilize and dry the closures.
BROCHURE: FVA Vertical Steam Sterilizer
PRODUCT: Reliance 480PG Pharmaceutical-Grade Washer
» Manufacturing
WHITE PAPER: Stabilizing Antibody Drug Conjugates
WHITE PAPER: Mixing And Blending Equipment: Give Renting A Try
PRODUCT: Pharmaceutical Capsule Filling
» Packaging
WHITE PAPER: Benefits Of Blister Packaging For Emerging Markets
By Paul Dupont, Ropack, Inc.
Global research on the pharmaceutical packaging market indicates that blister packaging will continue its robust growth, projected through the remaining decade to trail bottling only slightly in market share. While mature markets, such as Europe and Asia, already accept blister packs as a preferred method — and with North America stepping up its blister usage — these markets, surprisingly, are not the driving force in blister’s growth. Instead, the increase is expected, in large part, to be spurred by the benefits blister packaging brings to emerging markets where product protection, patient compliance, and the need for daily or weekly prescription dosages are often primary considerations.
DATASHEET: DFS, Dockable Flow Meter System
By Filamatic
PRODUCT: Pharmaceutical Checkweighers
» Logistics
WHITE PAPER: Ensuring Cold Chain Remains Cold And Control Room Temperature Remains Controlled!
WHITE PAPER: Track And Trace: Turn Compliance Into A Supply Chain Value Proposition
VIDEO: Mobile Refrigerator/Freezer: Energy Efficient, Precision Temperature Control
UPCOMING TRAINING

Process Validation Guide: Regulatory Expectations And Best Practices
Date: Wednesday, July 16, 2014 • Time: 1:00 pm to 2:30 pm EST

The Seven Characteristics Of A World-Class Supply Chain
Date: Tuesday, July 22, 2014 • Time: 1:00 pm to 2:30 pm EST
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