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Pharmaceutical Technology Featured Whitepapers
July 2013

Featured Whitepaper: Vaisala
The Care & Feeding of an Environmental Monitoring System: Getting to GxP Compliance & Staying There
Sponsored By: Vaisala

Not only must your software-based monitoring solution be integrated into your organization’s Quality Management System; its compliance must also be maintained over time. This App Note explains how to ensure continued GxP compliance in your monitoring system for temperature-controlled environments.

 
manufacturing
   
  OUTSOURCING
   

Managing the Complexities of Global Pharmaceutical Sourcing
Sponsored By: DPT Laboratories
With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. These trends have forced life science industry companies to optimize sourcing activities for raw materials, intermediates, active pharmaceutical ingredients (APIs), and other material components for clinical supplies and commercial manufacturing. Download this white paper to learn more.

 
Outsourcing
   
  MANUFACTURING
   

Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larking
Sponsored By: Kimberly-Clark Professional

This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination.

 

Sterile manufacturing – current trends and developments
Author: Jürgen Schäfer
Sponsored By: OPTIMA pharma GmbH

The introduction of blockbusters is diminishing. At the same time, biotechnology is just beginning to discover its potential. Even now, this paradigm shift is showing an effect on sterile processes.

 
Analytics Testing
   
  DRUG DELIVERY
   
 
Melt Extrusion – Shaping Dosage Forms in the 21st Century 
Authors: Charlie Martin; Feng Zhang, PhD; James C. DiNunzio, PhD
Sponsored By: Leistritz

Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides.
 
Ingredients
   
  ANALYTICAL TESTING
   

UV-Vis Performance Validation Software for Improved GLP/GMP Support
Sponsored By: Shimadzu
Conducting instrument validation manually is a cumbersome task. This paper presents software that makes it easy to conduct an entire series of regulation and standards-related operations, from the setting of validation conditions to data measurement, pass/fail judgment, and file storage.

 
Analytics Testing
   
  QUALITY CONTROL
   
 
Automated Audit Management Best Practices 
Sponsored By: Sparta Systems
In response to recent high-profile product safety issues, the quantity and breadth of internal audits and external audits of suppliers and outsourcing partners have increased significantly. With stepped up audits, inefficient, manual, siloed processes are now causing significant problems, including: poor communications and scheduling; inefficient use of auditor and auditee resources; inconsistent audit output; lack of visibility and oversight into trends; and difficulty in ensuring appropriate follow-up on corrective and preventive actions (CAPAs). All these issues can have an adverse impact on operational effectiveness and product quality.
 
Analytics Testing
   
  STANDARDS & REGULATION
   
 
OPC: The Ins and Outs to What It's About 
Author: Darek Kominek
Sponsored By: Matrikon OPC

The Every Man's Guide to OPC is an easy-to-read overview of the most popular industrial open connectivity standard, OPC. This paper first introduces the main idea behind OPC, shows why OPC is different from conventional (often proprietary) communication protocols, and explains how OPC helps overcome the limitations of such native protocols.