Newsletter | January 28, 2014

01.27.14 -- Merck Committed To Business After Failure To Deliver New Medicines

Pharmaceutical Online Newsletter
Manufacturing Logistics QA/QC
Critical Environments Inspection Packaging
» Featured Magazine Article
cGMP Issues Are Increasing In Pharma
By Gail Dutton, Contributing Editor
Big Pharma and small companies alike are failing when it comes to cGMP violations. The increasing number and complexity of global regulations, outsourcing, price pressures, and compressed time to market all contribute to these failures. Consequently, the number of compliance issues is expected to rise.
Featured Focus: Manufacturing
What You Should Know About Pharmaceutical Cleaning Validation
By Malcolm McLaughlin
Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited, and cost of validation can be lowered, if the cleaner supplier can provide support, allowing for pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation, as well as discussing the kinds of support services you should seek from your supplier of critical cleaning products, in order to optimize your cleaning validation process.
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.
WHITE PAPER: Blender Comparison: Pedestal Blender (PB) vs. Column Blender (CB)
SERVICE: Small-Scale Contract Freeze Drying
PRODUCT: Dry Granulation Systems
PRODUCT: Pharmaceutical Feeder For Microbatch Compaction: MicroDyne
PRODUCT: Steam Sterilizers With Vertical Chamber
» Logistics
WHITE PAPER: Using Dry Ice When Shipping Air Freight
By Mark Mohr, CSafe Global
Healthcare product manufacturers, transportation providers, and distributors have a moral, and in most cases also a regulatory, responsibility to help ensure the product arrives to the end user intact. Protection of product efficacy demands use of the latest reliable technologies available. People's lives truly depend on it.
ARTICLE: High-Value Biologic Drugs Will Demand A Comprehensive Supply Chain
By Ariette van Strien, Senior Vice President, Commercial Operations, Marken
The dramatic shift in our industry from small molecule drugs to high-value biopharmaceuticals is increasing the need to focus on logistics and supply chain management.
ARTICLE: Pharma Preps For Serialization
ARTICLE: A Historic Collaboration To Deliver Products Of 2 To 8 Degrees Celsius
CASE STUDY: Quick International's Reliable Cold Chain Solution To Deliver Medical And Pharmaceutical Products
WHITE PAPER: Biological Contamination Management In Aseptic Environments: Requirements And Expectations
By James Drinkwater
Biocontamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources.
WHITE PAPER: 21 CFR Part 11 Risk Of Noncompliance
BROCHURE: Identify And Control Critical Quality Attributes (CQA) With Materials Characterization Solutions
PRODUCT: Proportional Pressure Regulator And Pneumatics
» Critical Environments
WHITE PAPER: Material Compatibility With Vaporized Hydrogen Peroxide (VHP) Sterilization
By G. McDonnell
Various sterilization methods (including gamma irradiation and ethylene oxide) have been widely used for terminal medical device sterilization. No single method offers the perfect sterilization solution for every application.
PRODUCT: Counterpressure Sterilizers
PRODUCT: Fluid Control Systems For Sterilizers And Washers
PRODUCT: Biodecontamination Of Isolators
PRODUCT: BioSafe Waste Receptacles
» Inspection
WHITE PAPER: How To Effectively Avoid Metal Contamination Recalls
DATASHEET: Metal Detection And Checkweigher Combo System
By Loma Systems and Lock Inspection
SERVICE: Contract Metal Detection
PRODUCT: Oxygen And Carbon Dioxide Analyzer: PAC CHECK
PRODUCT: Used Checkweighers
» Packaging
CASE STUDY: Meeting Technical Challenges In Desiccant Dispensing
BROCHURE: DRcaps Acid-Resistant Capsules Brochure
SERVICE: Secondary Pharmaceutical Contract Packaging
SERVICE: Custom Design Health And Beauty Contract Packaging
PRODUCT: Food And Pharmaceutical Metal Detector: Vistus

Lyophilization Cycle Design: A Practical Guide To Process Optimization
Date: Tuesday, February 4, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST

Quality By Design (QbD): Successful Implementation For Pharmaceutical Development And Manufacturing
Date: Tuesday, February 25, 2014 • Time: 1pm – 2:30pm EST
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