Newsletter | April 22, 2014

04.22.14 -- QbD: Lessons Learned From An FDA Filing

Pharmaceutical Online Newsletter
» Featured Article
QbD: Lessons Learned From An FDA Filing
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Implementing quality by design offers not only a proactive approach to product development, but also the opportunity to streamline your filing process.
Featured Focus: Manufacturing
Does Your Tablet Deduster Fit Into Continuous Processing?
By Andre Petric, President, Kraemer US, LLC
With the manufacturing trend toward larger batch production and continuous processing, tablet manufacturers are dealing with mounting pressures to make more tablets, in less time, but with the same high quality. In response, companies have begun to use faster tablet presses, but issues arise when their dedusters can’t keep up with the new pace. Since dedusting is an integral link between the tablet press, coating, and packaging steps, it’s important to keep the following factors in mind to avoid unnecessary problems on your line.
ARTICLE: Cell Disruption By Means Of Homogenization
WHITE PAPER: Making A Difference In Hygienic Processing: Elimination Of Dead Space Volume
By Marc Klingler, Segment Manager Hygienic Processing, Bürkert Fluid Control Systems
Thanks to high functionality within minimal space, multiport valves ensure compact processes, facilitate excellent cleaning, and increase process reliability, therefore contributing to improved product yield.
WHITE PAPER: 8 Ways To Reduce Tablet Manufacturing Costs
APPLICATION NOTE: Weekly Equipment Auctions From Major Bio And Pharma Manufacturers
BROCHURE: Pharmaceutical Roller Compactor: WP 200
PRODUCT: Capsule Visual Inspection System: CVIS-EX3
» Critical Environments
WHITE PAPER: The Role Of pH And Residue In Pharmaceutical Cleaning
By Malcolm McLaughlin, Alconox
A great deal is known about how pH affects aqueous critical cleaning. Typically, alkaline cleaners are used on oily residues and acidic cleaners are used on inorganic residues.
WHITE PAPER: Hydrogen Peroxide Decontamination: Vapor vs. Aerosolized Systems
APPLICATION NOTE: Automatic Fill/Finish Packaging And Check Weighing System
BROCHURE: Compact Glassware Washer And Dryer
PRODUCT: Surface Decontamination Cabinets (FCD)
» QA/QC
WHITE PAPER: Monitoring Chemical Processes For Early Fault Detection Using Multivariate Data Analysis Methods
By Dr. Frank Westad, Chief Scientific Officer, CAMO Software
Multivariate statistical methods can be used to monitor process variables and predict final product quality at an early stage, while also providing deeper understanding of the process. This allows engineers and production managers to optimize their processes, thereby realizing significant cost and time savings.
WHITE PAPER: FDA Inspections Of Clinical Investigators: Are You Ready?
Published Jointly By MasterControl Inc. and Fujitsu Limited
Life sciences companies are developing cutting-edge medicines, medical devices, and therapies that entail increasingly complex clinical trials. As a result, regulators throughout the world have to step up their vigilance in overseeing clinical trials to ensure the safety of participants and the integrity of clinical research.
APPLICATION NOTE: Parallel Integrity Testing Of Small Venting Filters
SERVICE: Pharmaceutical Qualification Services
PRODUCT: Modular System For Nanostructure Analysis: SAXSpace
» Inspection
DATASHEET: Rapid Biologic Detection System For Air
By Azbil BioVigilant, Inc.
DATASHEET: Ultra-Light-Weight Checkweighers
By Loma Systems and Lock Inspection
BROCHURE: HIAC Liquid Particle Counter
PRODUCT: Vials And Ampoules Inspection Machine
PRODUCT: ScanAir Pro Airborne Particle Counter System
» Packaging
WHITE PAPER: Improving Uptime In Aseptic Processing Of Pharmaceutical Liquids
By Chuck Reed, Weiler Engineering, Inc.
Maximized uptime, minimized changeover time, and efficient OEE are key factors that have influenced the acceptance of aseptic blow-fill-seal in the packaging of pharmaceutical liquids.
CASE STUDY: Smart Cameras Reduce Implementation And Validation Costs In Pharmaceutical Serialization
DATASHEET: Assembly, Filling, And Packaging Of Depot Syringes
By Harro Höfliger Packaging Systems
VIDEO: Contract Pharmaceutical Bottling Filling Services
PRODUCT: Semiautomated Packet Dispenser
» Supply Chain
CASE STUDY: A Robust Cold Chain With A Proactive Quality Improvement Approach
DATASHEET: Small Thermal Pharmaceutical Shipping Containers: SVS
By CSafe Global
VIDEO: Reusable Insulated Shippers With Single-Use Flexibility
BROCHURE: Commercial Services: Sterile Manufacturing
UPCOMING TRAINING

Root Cause Analysis And CAPA Identification: A Step-By-Step Guide For Manufacturers
Date: Wednesday, April 30, 2014 • Time: 1pm – 2:30pm EST

Qualifying Your Trainers — What Do They Need For Your Training To Be Effective?
Date: Thursday, May 8, 2014 • Time: 1pm – 2:30pm EST

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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Small Indian Pharma Contract Producers Face Fierce Competition
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