Newsletter | July 31, 2014

07.31.14 -- What You Missed From The FDA Last Week; Lupin, Others Consider Bid For GSK Generics

Pharmaceutical Online Newsletter
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The Rx For GMP Compliance: Robust And Reliable Checkweighing
» Guest Column
Outsourcing Biomanufacturing Continues To Grow In Frequency
By Kate Hammeke, Contributing Editor
Nice Insight has learned from its strategic partnering surveys that the long-term strategies of many businesses in the pharmaceutical industry for maintaining a strong drug development pipeline include integration of biopharmaceuticals.
Featured Focus: Inspection
Design And Installation Considerations For VHP-Resistant Remote Particle Counters
CASE STUDY: Vision System Increases OEE By 200% On Pharmaceutical Packaging Line
WHITE PAPER: Slope's Effect On Accurate Weighing
BROCHURE: Lyostat 4 Freeze-Drying Microscope
BROCHURE: Xpert X-Ray Inspection System
» Manufacturing
ARTICLE: Proving The Value Of Strategic Partnerships: What Strong Relationships Can Accomplish
By Gareth Temple and Stuart Dean
Let’s be clear about something right up front. This is not a story about the benefits of outsourcing laboratory services. Rather, this is an entirely different approach to lab research, development, and management services called cosourcing, where on-site providers — often represented by a company's own former employees — work hand-in-hand with staff scientists to maintain and oversee multivendor instrumentation and related services.
BROCHURE: Affordable Rotary Tablet Press
PRODUCT: 3Flex Surface Characterization Analyzer
» Critical Environments
WHITE PAPER: The Role Of Biological Indicators For Hydrogen Peroxide Vapor Technology
By Dr. Lynne Murdoch, Bioquell UK Ltd
Biological indicators (BIs) have become the industry standard for verification of hydrogen peroxide vapor (HPV) decontamination efficacy.
APPLICATION NOTE: Instantaneous Microbial Detection Defined
PRODUCT/SERVICE: Steam Sterilizers With Vertical Chamber
» QA/QC
WHITE PAPER: Can Manufacturing Challenge QC On Viscosity Measurement?
By Robert G. McGregor, General Manager, Brookfield Engineering
The current batch of skin cream lotion seems ok to the eye. It has the same feel and appearance as all the other batches produced earlier in the week. Yet QC reports that it’s too thin, the viscosity value is low and the batch needs rework in order to meet the control spec. Manufacturing is suspicious that there is something wrong with the viscosity measurement. How do you go back and challenge QC when they own the instrument that made the reading?
BROCHURE: Versatile Cell Counter And Analyzer: Multisizer 3
PRODUCT: Analytical And Laboratory Benchtop Instruments
» Logistics
CASE STUDY: Quick International's Reliable Cold Chain Solution To Deliver Medical And Pharmaceutical Products
PRODUCT: Precision Data Loggers For Regulated Environments
PRODUCT: Off-The-Shelf Insulated Shipping Containers
» Packaging
APPLICATION NOTE: Pharmaceutical Product Traceability Achieved With 2D Barcode Reading
DATASHEET: MAC S-100 Blister Packaging Machine
By TASI Group: Bonfiglioli Engineering and Sepha
PRODUCT: Small-Volume Pharmaceutical Parenteral Packaging Systems
UPCOMING TRAINING

Improving Biological Facility Design: Critical Tips For Compliance
Date: Wednesday, August 6, 2014 • Time: 1:00 pm to 2:30 pm EST

Serialization Preparedness: What You Must Know For Bullet-Proof Programs
Date: Tuesday, August 12, 2014 • Time: 1:00 pm to 2:30 pm EST

Lyophilization: An Introduction To The Scientific Principles
Date: Wednesday, August 20, 2014 • Time: 1:00 pm to 2:30 pm EST
SPONSOR
Life Science Leader and BayBio bring you interactive panels on the challenges to managing outsourcing relationships. Panelists include Andy Skibo (RVP, AstraZeneca; EVP, MedImmune), David Lowndes (SVP, Shire), Bob Kanuga (VP, Merck), Junning Lee (SVP, Theravance Biopharma), Terry Novak (COO, Pernix Therapeutics), and others. Learn more.
» Most Recent News
DRG Lauds Evolocumab As The Gold-Standard Among PCSK9 Inhibitors
What You Missed From The FDA Last Week — July 21-25, 2014
Stallergenes Acquires Alergo Pharma, Enlarges Latin American Reach
Lupin, Other U.S. Firms Consider Bid For GSK Generics
FDA Recalls All Non-Expired Sterile Drugs From Unique Pharma
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