Whitepapers - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Whitepapers

Extractables and Leachables Testing for Medical Applications

July 29, 2014

Polymer materials offer many benefits when used for packaging in medical applications. It is important however, to thoroughly assess potential leachables by designing appropriate extractables conditions. A materials based approach to facilitate the identification and quantitation of all extractables and leachables is presented.

Strategies for Successful Scale- Up Using Quality by Design

July 22, 2014

This executive summary will outline best practices for ensuring successful scale-up for manufacturing finished drug products by offering a systematic approach and technical case studies for implementing QbD through development to scale-up to commercial manufacture.

Evaluation of a New Co-Processed Excipient “SmartEx” for Orally-Disintegration Tablets

June 25, 2014

A new co-processed excipient “SmartEx” has been developed for orally-disintegration tablets. The white paper contains results of studies on its physical properties, tablet performance, and stability.

Improving Product Quality with Risk Assessment Tools

June 25, 2014

With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is risk management. Learn the elements of risk management and how they help to identify, prevent, and mitigate risk throughout an organization.

Vaisala Mapping Kit: The Quickest Route to Environmental Validation

June 25, 2014

Reliable data from stable sensors eliminates the need to re-run studies, open deviation investigations, and spend extra time reporting. Simply download the software, place the loggers, and begin your study.

A Proactive Approach To Asset Management: Millions can be made by using a web-based asset management solution to keep track of idle pharmaceutical equipment and redeploy it elsewhere in the company.

June 25, 2014

A proactive approach to asset management is empowering life-science companies to get control of their manufacturing and laboratory environments. By identifying idle and surplus equipment, and subsequently selling that equipment, these organizations are able to fund new capital purchases, recoup money from capital that they already own, and uncover value from equipment that would otherwise continue to take up precious space in their facility. An asset management program that incorporates equipment redeployment, secondary market sales, online auctions, and even recycling can garner millions of dollars.

Good Practices for Calibrating and Managing Sensing Instruments Used in GxP-Compliant Applications

June 25, 2014

Created by Vaisala’s calibration experts, this eBook contains great information for new and expert metrologists managing instruments in GxP-compliant environments.

Evaluating Coder Technologies for Pharmaceutical Applications

June 25, 2014

Now that the deadlines for compliance are clear, pharmaceutical companies are fast transitioning from planning to implementation. And while serialization is a complex topic, working with a qualified coding provider can help you take one challenge off the agenda. Serialization success starts with a high-quality code on your packaging.

Best Practices for Effective Environmental Monitoring Programs

June 25, 2014

This white paper will explain what the regulations recommend for determining what to sample, where to sample, the various sampling method, and how to validate the results of environmental monitoring.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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