Newsletter | May 8, 2014

05.08.14 -- Human Error Is The Leading Cause Of GMP Deviations -- Or Is It?

Pharmaceutical Online Newsletter
» Featured Guest Column
Human Error Is The Leading Cause Of GMP Deviations — Or Is It?
By Joanna Gallant
Think of your company’s deviations. Concentrate on their most common root cause — the one you see most often and have the hardest time fixing. My high-tech mind-reading helmet tells me your answer is human error, correct? Magicians aren't supposed to reveal their tricks, but this one really isn't much of a trick. Every company wrestles with human error. We know humans have error rates — we’re not perfect. But how many is too many?
Featured Focus: Inspection
Eliminate Inspection Labor Costs On Your Blister Packaging Lines
By Giuseppe Bonfiglioli, Bonfiglioli Engineering
Production of tablets and capsules is carried out in cleanrooms and under stringent procedures as per GMP requirements. However, the process also relies on machines and machine operators, therefore, misappropriate handling can result in a faulty blister pack containing micro leaks in the packaging, allowing air and moisture to enter the blister and damage the product.
BROCHURE: Metal Detection System: Observer
BROCHURE: Servo Chuck Capper
PRODUCT: In-Process Controls Of Pharmaceutical Headspace Analyzers
PRODUCT: MET 30+ BatchChek Pharmaceutical Metal Detector
» QA/QC
ARTICLE: Zero Margin For Error: The New Reality For Generic Pharmaceutical Manufacturers
By Karen Bell, Product Marketing Manager, Revitas
Generic pharmaceutical manufacturers are facing a business dichotomy: The overall market for generic drugs is growing but at a slower pace as the number of branded drugs entering the market is shrinking, diminishing opportunities to capitalize on expiring patents. Consequently manufacturers face numerous challenges that can significantly impact operational efficiencies and revenue growth.
WHITE PAPER: The Hidden Value Of Instrument Manufacturers
By Tara S. Hundley, Anton Paar USA
For those of you who work with any analytical lab or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the work flow as soon as possible; but to do so you need to know everything there is to know about equipment and instrument qualification. In the overall pharmaceutical manufacturing process, you may be just one cog on the gear of productivity, but without some help, you could go from cog to clog very quickly.
BROCHURE: Contract Visual Inspection Services
BROCHURE: RST Touch Series Rheometers
PRODUCT: Classify Samples In Real-Time: Unscrambler X Classification Engine
» Manufacturing
WHITE PAPER: Guard Against Product Migration In Your Ribbon Blender
BROCHURE: UltraCap H.D. Capsule Filters
PODCAST: Liquid Filling Trends In Pharmaceutical Manufacturing
With Ken Himes
At Interphex 2014, Todd and Todd interview Ken Himes of Filamatic to discuss trends and innovations in the pharmaceutical manufacturing industry.
PRODUCT: ZetWALLET Packaging System
PRODUCT: Cadence Single-Use Inline Concentrator
PRODUCT: Branch-Specific Formed Packaging Solutions
» Supply Chain
ARTICLE: Shipping With Active Packaging Containers: Three Preflight Decisions That Impact The Success of High-Value Global Shipments
VIDEO: Safely Store And Transport Temperature-Sensitive Pharmaceutical And Biotech Products
PRODUCT: Greenbox Reusable Thermal Packaging
» Critical Environments
APPLICATION NOTE: Using A Laboratory Glassware Washer To Perform Pasteurization
DATASHEET: Pharmaceutical-Grade Washer 680PG
By STERIS Corporation
BROCHURE: Tissue Culture CO2 Incubator
PRODUCT: Filtrete Commercial HVAC Filters Mini-Pleats With Gasket
PRODUCT: Laminar Flow Glovebox Isolator
PRODUCT: Flexible Containment Isolators
» Packaging
BROCHURE: Retort Pouch Inspection
PRODUCT: Syringe Filling Equipment From Bosch Packaging
PRODUCT: High-Volume Production Blow/Fill/Seal Machine
PRODUCT: Pharmaceutical Contract Blister Packaging Services
SPONSOR
The 4th Traceability and The Drug Quality and Security Act Summit, May 15 and 16, 2014, at the Sonesta Hotel in Philadelphia, PA, brings together a cross section of supply chain, serialization, traceability, security, and brand protection experts to discuss the impact of the DQSA, best practices to optimize and protect your supply chain, and how to provide business value through serialization and pedigree beyond regulatory compliance. Register today with discount code "C452LCS". Learn more.
UPCOMING TRAINING

Renovating Pharmaceutical Manufacturing Facilities For Aseptic Fill/Finish: Critical Planning, Execution, And Compliance Tips
Date: Tuesday, May 20, 2014 • Time: 1pm – 2:30pm EST
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New ColdMark2 Indicator Lowers Temperature Threshold To 0°C
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