Pharmaceutical Technology Featured Whitepapers
August 2009
Featured Whitepaper
BioAnalytical Quality Standard Initiative — Implementing ICH Q10 for Clinical Trials
Author: J. Kirk Smith, Ph.D., Sr. Director, Regulatory and Quality Systems and John P. Pirro, Vice President and Chief Operating Officer; Sponsored by: Synomics Pharmaceutical Services
Over the course of the last year, a pharmaceutical industry consortium has been leading the initiative to develop an industry acceptable guideline applicable to standardizing acceptable laboratory and quality management practices for bioanalytical studies supporting clinical trials. Participating in the initiative are representatives from a number of top worldwide pharmaceutical and generic companies. The initiative was born out of the industry wide recognition that neither the US FDA or EMEA regulation nor ICH harmonized guidelines address laboratory analysis in support of clinical trials.
 
Outsourcing: A Rapid, Cost-Effective Option for Electronic (eCTD) Submissions
Sponsored By: Beckloff Associates, Inc.
Pharmaceutical and biotech sponsor organizations are in increasing numbers making the switch from paper to electronic (eCTD) format for their marketing applications to FDA. Given the current difficult economic environment, sponsors, especially those with modest submission volumes, should consider outsourcing as a great option to enable the strategic benefits of eCTD while significantly reducing the barriers.
 
Swab/Direct Combustion Analysis of Detergent Residue
Sponsored By: Shimadzu
At pharmaceutical facilities, it is essential that residues of previously processed products and detergent used for equipment cleaning do not exceed specified permissible limits. In this application, quick, accurate measurement with a TOC analyzer, in combination with a solid sample combustion unit, is shown.
 

A Tale of Two Thermals
Sponsored By: Sierra Instruments
Part one of the three–part core technology white paper series discusses the principle of operations of capillary thermal and immersible thermal gas mass flow measurement technologies. Taken together, these two methods cover a wide spectrum of gas mass flow measurements typically found in industrial applications.
 
Improved Compressed Air Plant Efficiency
Author: Bruce E. McDuffee; Sponsored By: Vaisala, Inc.
Compressed air is one of the least efficient forms of energy that is used in modern manufacturing plants. It takes 7 to 8 times more electricity to produce 1 horsepower with compressed air versus 1 horsepower with an electric motor. Compressed air is often the largest end-use of electricity in a plant.
 
Technology Approaches to Quality Management
Author: Mike Jovanis; Sponsored By: Sparta Systems Europe, Ltd.
Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations. These pressures stem from a number of different areas including a wide range of international regulatory authorities, global customers and other key stakeholders.
 
Protect Your Intellectual Property: Proof of Authenticity is Your Best Defense
Author: Tom Klaff, CEO; Sponsored By: Surety, LLC
In today's digital world, altering an electronic document or record containing critical formulas or data takes nothing more than motive and a keystroke - forcing R&D organizations to rely on the trustworthiness of their people, processes and technology to vouch for the authenticity of their records. You insure your employees, your buildings, your products and your systems against unforeseen trouble.why wouldn't you protect the integrity of your organization's critical electronic content the same way?
 
Achieving a Perfect Induction Seal Every Time
Author: Ryan Schuelke; Sponsored By: Enercon Industries Corporation
Inspired by the rave reviews of Enercon's webinar: "Achieve a Perfect Seal Every Time". This graphically rich whitepaper provides all the basic and advanced setup, operating, and troubleshooting techniques required to ensure a perfect seal every time.
 
ADVANTAGES OF COLLECTING PM2.5 PARTICULATE TODAY
Author: Tom Anderson; Sponsored By: Midwesco® Filter Resources, Inc.
Scientific studies have suggested that long term exposure to fine particulate matter may be associated with increased rates of chronic bronchitis, reduced lung function and increased mortality from lung cancer and heart disease. Thus the EPA is setting standards for fine particules: an annual standard (yearly) and a 24-hour standard, designed to provide additional protection on days with high peak PM2.5 concentrations. Earlier this year, the EPA has enacted industrial manufacturing plants to become PM2.5 compliant within 24 months, so why do so now?
 
Modern tools for hopper design
Author: Tim Freeman; Sponsored By: Freeman Technology Ltd.
Although there are well-established methodologies for hopper design, many process engineers are uncertain as to how to measure powders in the prescribed way, extract the necessary parameters from recorded data, and successfully apply them. As a result, hopper design and the powder testing associated with it is often outsourced to specialists. This incurs significant cost and undermines the operating company’s ability to troubleshoot and re-use or retrofit equipment for alternative materials or applications.
 
Bulk Inspection of Tablets: Assuring Product Quality at Manufacturing and Packaging
Sponsored By: Symetix
Achieve new levels of product quality and inspection efficiency in the manufacturing and packaging of tablets. Learn the pros and cons of manual inspection, mechanical sorting, blistering, single-file optical systems and a new class of automated, bulk vision inspection systems. The latest technology is keeping pace with the increasing demand for top-quality products. Learn how it helps minimize risk, increase throughput and contain costs.
 
Risk Evaluation and Mitigation Strategies (REMS) Under FDAAA
Sponsored By: Beckloff Associates, Inc.
The highly publicized withdrawal of a number of unsafe drugs from the market over the last several years has led to strong criticism of FDA’s ability to protect the public health, resulting in a call for fundamental changes in the United States drug safety system. On March 25, 2008, new legislation designated as the Food and Drug Administration Amendments Act of 2007 (FDAAA; “the Act”) took effect, which directed FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle, with an explicit focus on postapproval safety.
 
Topical Dermatological Formulation Development - "Things You Should Know"
Author: Vanlee Waters M.B.A., Marketing Manager; Sponsored By: Dow Pharmaceutical Sciences, Inc.
"Things You Should Know" will answer many of your questions and will provide insight into issues you may not have considered -- but should be aware when developing a topical formulation. The target product profile, dosage form selection, reasons for multiple excipients, the formulation development process, prototype screening, and lead formulation selection are discussed.
 
Uncovering the root cause of contamination and leveraging the collaborative learning loop of QbD
Author: Justin Neway, Vice President and Chief Science Officer for Aegis Analytical Corp.; Sponsored By: Aegis Analytical Corp.
This article will share a detailed case study problem-solving example about a pharmaceutical manufacturer investigating a contaminant for a specific drug outcome. Step-by-step tutorial descriptions and graphics will illustrate how multivariate analysis can be used to determine the root cause of contaminated batches and ultimately solve the problem by accounting for batch genealogy.
 
 

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