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Labcompliance News, December 2003

Dec 10, 2003

Eurachem Updates "Traceability in Chemical Measurement" Guide

This Guide gives detailed guidance for the establishment of measurement traceability in quantitative chemical analysis, based on the definition in the international vocabulary of basic and general terms in metrology (VIM). Though it is aimed principally at testing and measurement laboratories carrying out chemical measurement, the principles are expected to apply from routine analysis to basic research. The document is also intended to assist laboratories in meeting the requirements on traceability of results given in ISO 17025.

Dec 10, 2003

FDA Publishes New Revision of Q1A(R2) Stability Testing of New Drug Substances and Products

This guidance is intended to define what stability data package for a new drug substance or drug product is sufficient for a registration application within the three regions of the European Union (EU), Japan, and the United States. This is the second revision of Q1A Stability Testing of New Drug Substances and Products, which was first published in September 1994 and revised in August 2001. The purpose of this revision is to harmonize the intermediate storage condition for zones I and II. The changes made in this second revision are listed in the attachment to this guidance. Recommendations for zones III and IV recommended are published in the ICH guidance Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV.

Dec 02, 2003

The US FDA is developing an Integrated Agency-wide quality systems guidance.

Details on the status, objectives, timelines and working groups have been presented at the Japan PDA Annual conference by FDA's James S. Cohen, Associate Director for Compliance and Biologics Quality and Research at CBER. The guidance is expected to be released by August 2004. In his presentation Mr Cohen also discussed and presented status and/or further FDA plans, for example: seven steps to speed drug product availability, transfer of therapeutic products from CBER to CDER, international collaborations, science-based policies and standards and experience with risk-based system inspection approaches (warning letters).

Dec 02, 2003


Networks Should Comply with GMP and Part 11

At the FDA/ISPE part 11 web seminar Sion Wyn, co-author of the part 11 final guidance on scope and applications, and George Smith, National Expert and a member of the FDA's part 11 taskforce gave advice on part 11 compliance of networks. Mr. Smith made it very clear: "Networks used in a GMP environment should be validated". And Mr. Wyn explained: Networks on which applications reside should be looked as a very important component of the environment but are separate from the actual applications themselves and do not hold primarily part 11 records. In order to ensure that applications and systems running on the network operate correctly you need to be in control of the infrastructure through adequate procedures, adequate quality assurance, adequate documentation. FDA's Mr. Smith added: The network itself should be validated in a GMP environment and the system would be the one that needs to address part 11. Mr. Wyn further explained that when part 11 records are transferred through a network during their lifecycle you have to make sure that during that transmission the records are transmitted securely and accurately.

You can learn at your desk or in your own seminar/conference room what this means in practice and how GMP and part 11 compliance can be achieved at lowest costs. Information will be conveniently delivered in a new on-line audio seminar on Thursday, December 11: Strategies for Cost Effective Network Compliance
with Dr. Ludwig Huber as presenter. The seminar will be conducted over the phone supported with the Internet. To get more information on content and registration, click here.
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Dec 20, 2003

On-line Audio Seminars: New Service from Labcompliance

Now Labcompliance provides basic and on-going updated information on validation and compliance through on-line audio seminars. With this new service you can learn from the convenience of your desk or with your colleagues in your seminar room. Click here to learn what audio seminars are, what the benefits are, which topics are available and the dates, how you can register and how the information is delivered. The first one on "Strategies for Cost Effective Network Compliance and System Uptime" has been delivered with great feedback from the audience.