Newsletter | April 8, 2014

04.08.14 -- FDA Rebukes Efforts To Limit Access to Zohydro; GSK Halts Trial for Cancer Treatment

Pharmaceutical Online Newsletter
Departments:
Critical Environments Logistics Manufacturing
Inspection QA/QC Packaging
» From The Editor
The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together
By Milton Boyer, President, OSO Biopharmaceutical Manufacturing
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization.
Featured Focus: Critical Environments
Challenges With Modern Oncology Drugs: Aseptic Preparation Of Cytotoxic Compounds
By Jane Metcalfe, BSc (Hons), MSc, Field Applications Specialist, Bioquell UK Ltd
This white paper focuses on the challenges facing modern oncology pharmacies concerning the aseptic preparation of cytotoxic drug compounds. It considers the current regulatory and health and safety issues faced by pharmacists and details some of the measures to tackle these problems such as the use of isolator technology and the application of good manufacturing practice and quality risk management principles.
WHITE PAPER: Understanding And Resolving Risks Of Combustible Dust In The Pharmaceutical Industry
By Paul Miller, Vice President and General Manager, Nilfisk Industrial Vacuums
An estimated 30,000 U.S. facilities are at risk for a combustible dust fire or explosion, according to the Occupational Safety and Health Administration (OSHA). Many of you are likely thinking, “Well, not my company.”
WHITE PAPER: Decontamination By Hydrogen Peroxide: Use And Technical Developments
WHITE PAPER: High Containment For Potent Product Transfer
APPLICATION NOTE: Recommended Cleanroom Gowning Room Design
PRODUCT: VHP Resistant Particle Counters
» Logistics
CASE STUDY: IMP Shipments: Too Big, Too Costly, Too Bad
VIDEO: Connected Sensors Unlock New Value In Transportation And Logistics
Featuring Carrie Magillivray Program VP Mobile Services, M2M and Network Infastructure
New applications for the tracking of cargo and assets that are time- and temperature-sensitive and of significant value.
VIDEO: True Enterprise Cost Of Cargo Theft And Loss Of Control
SERVICE: Insulated Shipping Inspection: Reuse, Recycle, REPAQ
» Manufacturing
Q&A: The Benefits Of New Biopharma Products For Single-Use Systems
By Max Blomberg, Director of Operations, Meissner Filtration Products; and Trisha Gladd, Editor, Bioresearch Online and Pharmaceutical Online
Meissner Filtration Products recently introduced two new products related to single-use systems — a next-generation, single-use mixing system and a plug-and-play filter solution.
MAZAGINE ARTICLE: Risk Management: Controlling Supply Chain And Process Risk In Biomanufacturing
APPLICATION NOTE: Sterilizing Filtration Of Enriched And Pure Gaseous Oxygen Employed In Cell Culture Applications
WHITE PAPER: Blender Comparison: Pedestal Blender (PB) vs. Column Blender (CB)
DATASHEET: Continuous Effluent Decontamination (CED) System
By STERIS Corporation
BROCHURE: Improve Manufacturing Quality And Performance: Vision Systems And Sensors
PRODUCT: Filter Systems For Pharmaceutical Separations
» Inspection
ARTICLE: A Healthy Outlook On Inspection
CASE STUDY: Contract Manufacturer Avoids Increased Costs And Labor Costs With Inspection System
VIDEO: MediScan: Nondestructive Leak Detector
PRODUCT: Used Checkweighers
PRODUCT: Fast And Easy Viscometer Measurements: DV2T
» QA/QC
BROCHURE: How Efficient Are Your Document Management Processes?
BROCHURE: One Rheometer. Two EC Motors. All Possibilities
PRODUCT: Intermediate Bulk Containers For Bulk Liquid Handling
PRODUCT: Cleaning Validation Methods
PRODUCT: Gas Adsorption Sample Preparation Device
» Packaging
DATASHEET: Stick Pack Machine: Customizable Pouch Shapes
By PTI Packaging and Inspection Systems
PRODUCT: Unused Automated Labeling Systems
PRODUCT: Pharmaceutical Dosing And Filling: API
PRODUCT: Automated Capsule Filling System
PRODUCT: Secondary Pharmaceutical Contract Packaging Services
SPONSOR
The 4th Traceability & 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".
UPCOMING TRAINING

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

Effective Investigations And Root Cause Analysis: A Step-by-Step Guide for Manufacturers
Date: Wednesday, April 30, 2014 • Time: 1pm – 2:30pm EST
» Most Recent News
FDA Approves New Hand-Held Auto-Injector To Reverse Opioid Overdose
Actavis Acquires Silom Medical Company For $100M
Janssen Files NDA For New HIV Combo Drug
FDA Rebukes Efforts To Limit Access To FDA-Approved Zohydro
GSK Halts Trial For Immunotherapy Cancer Treatment
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