Newsletter | March 13, 2014

03.13.14 -- FDA Prompted To Review Testosterone Products

Pharmaceutical Online Newsletter
Manufacturing Critical Environments Packaging
Inspection QA/QC Logistics
» Featured Podcast
A Master Plan For Designing And Developing Pharma Manufacturing Operations
Listen to radio hosts Todd and Todd talk to Paul Melamud, Director, Facilities/Utilities/Equipment Compliance at QPharma, Inc. and Scott Collins, Director, Laboratory Operations and Compliance at QPharma, Inc. about validating solutions and partnerships.
Featured Focus: Manufacturing
Strategies For Increasing The Value Of A Commodity Product
By Gregg Gordon, Senior Director, Manufacturing Practice
If your product has been commoditized, there are still many strategies to use in order to increase the value of a commodity product, and performing some market and customer research may yield some ideas to breathe new life into those now low-margin products.
APPLICATION NOTE: Determining Particle Size Distribution: Important Milling And Micronization Factors
DATASHEET: Pharmaceutical Solenoid Valve With Isolating Diaphragm
By Bürkert Werke GmbH
The 2/2 and 3/2 Way Flipper Solenoid Valve for analytical applications is only 4.5 mm wide, medium isulation, is suited for aggressive fluids, is direct acting, and has vacuum up to 7 bar and short response times.
DATASHEET: Vertical Laboratory Autoclaves
By Fedegari Group
DATASHEET: High-Pressure Homogenizer And Pump
By GEA Niro Soavi
BROCHURE: Pharmaceutical Roller Compactor Customized For Containment
BROCHURE: ULTRA-PACTOR High-Containment Roller Compactor
» Critical Environments
Q&A: Basics Of Labwasher Cleaning Validation
A Q&A with James Espiritu, Laboratory Equipment Business Applications Manager, Miele
Validation is vital to pharmaceutical processes because it assures quality, consistency, and keeps your operations compliant with GMPs. The FDA provides guidance for proper cleaning validation, however, challenges occur because interpretation of those procedures varies between facilities.
PRODUCT: Powder Handling Downflow Booth
PRODUCT: Biopharmaceutical Cleaning Validation
PRODUCT: Pharmaceutical Biological Indicator For 6-Log Reduction: HPV-BI
PRODUCT: Validatable Vacuum Sealers: Accu-Seal 8000
PRODUCT: Pharmaceutical-Grade Washer: Reliance 480PG
» Packaging
WHITE PAPER: A Guide To Effectively Sourcing And Purchasing Liquid Filling Systems
By Robert Rosen, Filamatic
There are a few questions to ask yourself when determining which liquid filling machine is right for your project. As each machine is unique in its filling techniques and performance abilities, certain questions that are asked will help to narrow down the choices and select a machine that will best suit your application.
DATASHEET: DFS Piston Pump Filler
By Filamatic
BROCHURE: Continuous Reliability Program Dispenser Preventative Maintenance Service
PRODUCT: Custom Handling Of Tablet Blisters (Tray Loading And Unloading)
PRODUCT: Industry Applications Guide To Vision: Pharmaceutical And Medical Device
» Inspection
APPLICATION NOTE: EU GMP Annex 1:2008 And Particle Counting: Part 1
DATASHEET: Precision Compression Load Cell
By Sartorius Intec
BROCHURE: Laser Diffraction Particle Size Analyzer
PRODUCT: High-Voltage Leak Detector
PRODUCT: Automated Inspection Machine: Prefilled Syringes
WHITE PAPER: A 15-Minute Guide To Clinical Trial Document Management And The eTMF
CASE STUDY: Process Train Containment In CMO Operations
VIDEO: Reducing Costs And Improving Quality In Pharma Production
BROCHURE: Unscrambler X Prediction Engine: Quality Control And Multivariate Software
PRODUCT: Lyophilization Cycle Optimization
» Logistics
WHITE PAPER: Scientific Standards For Ambient Temperature Profile Development
By Kenneth Maltas, Vice President of Engineering; Auston Matta, Engineering Team Lead R&D; Kevin O'Donnell, Technical Director; D'Arcy Ryan, Director of Marketing, ThermoSafe, Sonoco Protective Solutions
Storing and shipping highly temperature-sensitive drug products requires sophisticated packaging to ensure that the product remains safe and viable — from the manufacturing plant to the end user.
WHITE PAPER: Understand The Source Of Product Damage With Data Loggers
CASE STUDY: Genesis Genetics Saves More Than 50 Percent In Shipping Costs With Passive Packaging Solution
VIDEO: Comprehensive Supply Chain Integrity Solutions
PRODUCT: Temperature-Sensitive Shipments: RKN t2 Container

Vendor Qualification And Compliance: What Sponsors And CMOs Must Know
Date: Tuesday, March 25, 2014 • Time: 1pm – 2:30pm EST

Quality Agreements And FDA: What You Must Know To Comply
Date: Wednesday, April 2, 2014 • Time: 1pm – 2:30pm EST

Computer Systems Validation (CSV): Avoiding The Top Five Regulatory Pitfalls
Date: Wednesday, April 9, 2014 • Time: 1pm – 2:30pm EST
» Most Recent News
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