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Labcompliance News, March 1999

Mar 18, 1999

International Symposium on Spectroscopy&QualityControl

A new guide, entitled "Quality Assurance in Research and Development and Non-Routine Analysis" has recently been published with the endorsement of both CITAC and EURACHEM. The guide is intended to promote and facilitate the design and implementation of QA in the non-routine world.
Copies of the guide can be downloaded free of charge from the EURACHEM homepage

Mar 15, 1999

OECD GLP Consensus Papers Online

The Organization for Economic Cooperation and Development (OECD) develops GLP principles but also consensus papers in workshops. The goal is to reach a common understanding of specific aspects between industry and regulatory a agencies..
Now these documents are available free of charge from the internet. Most relevant to the topics of LabCompliance is the Monograph number 116: Application of the Principles of GLP to Computerised Systems
The OECD principles are important for pharmaceutical companies who develop, manufacture and market drugs for OECD member countries. For more info click here.
This input to LabCompliance came from Hans Olthof from Solvay Pharmaceuticals. Thanks to Hans.

Mar 15, 1999

Laboratory Guide to Method Validation from EURACHEM

The guide has 56 pages and has been developed by a EURACHEM Working Group from a draft originally produced by LGC. It covers all practical aspects and examples for analytical method validation. The guide is copyright protected but can be downloaded for private and non-commercial use from the EURACHEM homepage

Mar 1, 1999

New section on electronic records/signatures: 21 CFR Part 11

For regulated pharmaceutical laboratories electronic recording of analytical data, methods and other information about analyses is becoming important. The major reasons are

  • FDA's release of Part 11 of CFR 21 on electric signatures and records.
  • The trend towards paperless documentation, for example, for new drug applications.

Currently users of analytical equipment are unsure on what exactly to do. In this section we will give guidelines on how to implement Part11 of CFR 21 in analytical laboratories. Click here.