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| home > pmps > autumn 2001 > validation of facility monitoring systems - a practical approach |
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Pharmaceutical Manufacturing and Packing Sourcer
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Validation is a word that most people within the pharmaceutical industry know, and they generally have a good understanding of its terminology. However, computer systems validation is often regarded as a black art that should be avoided unless you are well-versed in the relevant spell books!
The problem, of course, is that computers are everywhere - formulations, stock control, integrated manufacturing, vision inspection systems, laboratory analysis, environmental monitoring systems and so on. They are even in places where you don't expect them - chart recorders, temperature controllers and the like.
Simply having an understanding of computers and software systems is not enough to validate a system. It is essential to fully understand the process and the equipment that is being validated. The people who have the best understanding of the equipment are the manufacturers, but often they know little or nothing about validation.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
More info >> |
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