Featured Whitepaper: Vaisala
50+ FDA Acronyms that Matter to Your Business
Sponsored By: Vaisala
This e-book is a convenient and comprehensive reference of definitions, insights, and additional resources that provide a fundamental understanding of FDA regulations in order to achieve Good Manufacturing Practices and FDA compliance.
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WORKING WITH A CDMO TO IDENTIFY OPTIMAL PACKAGING OPTIONS
Sponsored By: DPT Laboratories
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage.
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A Scientific Approach to Good Manufacturing Practices
Author: Chris Phillips
Sponsored By: Albany Molecular Research
Contract manufacturing organizations (CMOs) exist in an environment of continuous improvement and evolving quality standards. By scientifically affirming every decision and by embracing integral approaches to quality, CMOs can reduce regulatory risk and become a leader in developing best practices meeting current Good Manufacturing Practices (cGMPs). |
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Finding the right contract manufacturer
Sponsored By: Vetter Pharma International GmbH
Contract manufacturing became popular in many industries during the 1990s as a way to counter rising costs and to reinvestment. The pharmaceutical industry has been slow to adopt this practice because of its absolute need for secrecy.
However, with fewer blockbuster drugs in the pipeline, companies are on the lookout for an enduring solution to meet market challenges. These include rising process costs resulting from stricter quality control criteria, evolving technologies, which are becoming more complex and costly, and the increasing stringency of regulatory standards. To maintain or expand market shares, pharmaceutical companies must devise new strategies to remain competitive |
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Choosing the Best Microbial ID Contract Lab
Author: Mark Calmann
Sponsored By: Accugenix, Inc.
To justify a decision to outsource, an accurate analysis by the organization’s technical, quality and financial team is required. Presented in this publication are six critical elements to evaluate a contract laboratory service for microbial identifications. Outsourcing can drive cost savings, increase operational efficiency and leverage internal resources to focus on core competencies. |
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Sample Preparation for Quantitative Metal Impurity Testing
Author: Gayla Velez
Sponsored By: SGS Life Science Services
When analyzing for trace metals using inductively coupled plasma (ICP), sample preparation is crucial. The key question is what is the best method to get the test article in solution? |
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Forensics Can Help Identify Particulate Contamination
Author: David Exline
Sponsored By: Gateway Analytical
New forensic techniques and approaches are essential for resolving potential safety issues. This white paper discusses an investigative approach to help companies avoid FDA Form 483s by addressing OOS results and nonconformance issues. |
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Hot Melt Extrusion (HME) - nano-scale compounding developments
Author: Charlie Martin
Sponsored By: Leistritz
Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of APIs/excipients via extrusion to determine process viability. Experimental data is presented on a new twin-screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. |
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larkin
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. |
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AQUEOUS CRITICAL CLEANING IN PHARMACEUTICAL MANUFACTURING
Author: Malcolm McLaughlin
Sponsored By: Alconox
Examination of the benefits of aqueous cleaning for pharmaceutical manufacturing. Any equipment from tablet press to stainless steel mixing tanks can achieve their defined critically clean criteria using aqueous cleaning.
Alconox is the leader in pharmaceutical critical cleaning detergents. |
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Technical Choices for WFI Production
Author: Geoff Sheffrin P. Eng.
Sponsored By: OBK Water – Division of OBK Technology Ltd.
WFI from a ‘still or from two pass RO?’ Is the ‘still unquestionably safer than the two pass RO?’ The question continues to cause discussion between the jurisdictions. Neither is foolproof. |
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Quality Management Systems Demystified
Author: KR Karu
Sponsored By: Sparta Systems, Inc.
Learn how companies are utilizing best-of-breed ERP, EQMS, and PLM systems to save organizations money while increasing compliance at the same time. |
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OPC: Data sharing between Pharmaceuticals and CMOs
Author: Darek Kominek
Sponsored By: MatrikonOPC
Competition in the Pharmaceutical industry is driving companies to find efficient production strategies. Outsourcing production to CMOs is popular and with it the need to share production data. |
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How customized European Qualified Person (QP) training is breathing new life into US Pharmaceutical and Biotech companies.
Author: Mr Neil Wilkinson & Mr Jim Morris
Sponsored By: NSF-DBA (USA) LLC
As companies prepare their 2012 training budgets, it’s time to see what new training is on offer in the US and NSF-DBA’s QLP modular course, customized from Europe may be just the answer. |
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Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ, Inc
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. |
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Benefits of a Contract Packaging Partner
Author: Paul Dupont
Sponsored By: Ropack Inc.
As pharmaceutical companies face multiple pressures – to fast track innovative drugs and delivery systems, to meet increasingly stringent regulations and to grow resources despite increasing costs – outsourcing of packaging is reducing those pressures. Three essential characteristics are often overlooked, but essential, when choosing a packaging partner. |
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