Newsletter | March 27, 2014

03.27.14 -- Valproic Acid Might Help To Prevent Certain Cancers

Pharmaceutical Online Newsletter
Departments:
Manufacturing QA/QC Logistics
Critical Environments Packaging Inspection
» From The Editor
Strong Data Is Generated By Strong People
By Joanna Gallant, Joanna Gallant Training Associates
In the event you've been living under a rock for the last several months, facility inspection information released by the FDA has thrust data integrity into the spotlight. As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control — assuming we will put the time into executing them.
Featured Focus: Manufacturing
Overcoming Obstacles In Final Ultrafiltration Steps
By Nick Hutchinson, Market Development Manager
Cross-flow filtration can be used in a range of applications within biopharmaceutical manufacturing processes.
WHITE PAPER: New Options For Pharmaceutical Solid Dosage Forms
By Sharon Nowak, Coperion K-Tron
The combination of twin-screw extruders, loss-in-weight feeding, and pneumatic refill systems is quickly becoming the manufacturing process of choice when developing pharmaceutical solid dosage forms.
WHITE PAPER: Viscometer vs. Rheometer: Which Is The Better Choice?
CASE STUDY: How To Achieve A Dramatic Yield Increase Through The Use Of Antisegregation Technologies
PRODUCT: Single-Shell Storage Vessels
PRODUCT: C Technologies IO Fiber Optic Dissolution System
BROCHURE: Washer-Sterilizers
» QA/QC
WHITE PAPER: Be In Control Of Product Quality: Do Not Just Rely, But Understand
By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based solely on reliance of vendor certifications, statements, and promises. To diminish such reliance new technologies have been implemented such as process analytical technologies (PAT), process controls, automation etc. Often, once again, these new technologies have been overexerted as the solution to all problems, activities that supposedly result in higher product quality due to better process controls.
WHITE PAPER: A 15-Minute Guide To Efficient And Compliant Management Of GMP-Controlled Documents
DATASHEET: Blow-Fill-Seal Bottelpack
By rommelag USA, Inc.
BROCHURE: Multiwave GO: Best Of Both Monomode And Multimode Microwaves
PRODUCT: 3Flex Surface Characterization Analyzer
» Logistics
WHITE PAPER: Track And Trace: Turn Compliance Into A Supply Chain Value Proposition
WHITE PAPER: Why Modality Solutions?
WHITE PAPER: Safeguarding The Global Pharmaceutical Supply Chain
CASE STUDY: Marken Overcomes A Snow Emergency To Deliver Life-Saving Drug
PRODUCT/SERVICE: Via Prequalified Universal Insulated Shipper
» Critical Environments
WHITE PAPER: Improve Efficiency In Biocontamination Control And Risk Mitigation
By James Drinkwater, Bioquell Inc.
There is a need to improve efficiency in the pharmaceutical industry to meet the new challenges of globalization, competitiveness, and the increasing diversity of products.
BROCHURE: Airegard: Cleanroom Air Scrubber
PRODUCTS: Medical Device Cleaning Detergents
PRODUCTS: Pharmaceutical Cleanroom And Containment PODs
PRODUCTS: Formed Packaging: Water Soluble Film
PRODUCTS: Cleanroom-Produced Form Fit Bulk Container Liners
» Packaging
ARTICLE: Advances In Aseptic Blow-Fill-Seal Processing: Improve Product Integrity And Patient Safety
POSTER: Monitor Headspace Oxygen With A Rapid And Nondestructive Method
VIDEO: Contract Solid Dose Packaging Services For Pharmaceutical And Consumer Healthcare
SERVICE: Contract Manufacturing And Packaging Services
PRODUCT: Used Pharmaceutical Metal Detectors
» Inspection
ARTICLE: Using 100% Headspace Inspection For Characterizing And Optimizing Parenteral Manufacturing Processes
DATASHEET: Lightweight Checkweighers
By Loma Systems and Lock Inspection
BROCHURE: Inspection And ID Solutions For Pharmaceutical And Medical Devices
BROCHURE: Tablet Visual Inspection System, Batch Saver
PRODUCT: ETAC Easy View: Computer-Based Visual Inspection
UPCOMING TRAINING

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

Effective Investigations And Root Cause Analysis: A Step-by-Step Guide for Manufacturers
Date: Wednesday, April 30, 2014 • Time: 1pm – 2:30pm EST
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