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| home > epc > autumn 2003 > industry trends in the development and provision of 21 cfr part 11-compatible equipment |
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 PUBLICATIONS |
European Pharmaceutical Contractor
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Background
The FDA's 21 CFR Part 11 has been in effect since August 1997. Part 11 establishes the standards for ensuring electronic records and electronic signatures are as trustworthy and reliable as paper records and handwritten signatures. The regulation 'applies to records in electronic form that are created,
modified, archived, retrieved or transmitted under any records requirements' (1) as set forth by a predicate rule. Predicate rules include any requirements set forth by any FDA regulation, such as good laboratory practice (GLP), good manufacturing practice (GMP) and good clinical practice (GCP).
In the years following the introduction of Part 11, as industry began to attempt to comply with its requirements, the implications and broad scope of the rule became apparent. Pharma companies were expected to be making progress towards compliance with Part 11 by:
Assessing their current systems against the requirements
Determining the actions needed for each system to attain compliance
Developing procedural and technical controls
Generating and executing validation and implementation plans
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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 Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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