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Labcompliance News, June 1999

June 1, 1999

Glossary on compliance, validation etc

An agreement on the terminology is of utmost importance for a common understanding of compliance, validation, calibration and qualification. It frequently happens at validation/compliance symposia that different speakers used different terms for the same thing and the same terms for different things. As a consequence a discussion started on the topic of terminology which not only wasted quite some valuable symposium time but also left some uncertainty, because usually official definitions have not been readily available for clarification and the speakers could not get to a consensus.

The main problem is that guidelines on compliance, validation and qualification have been developed by different organizations, at different times and in different countries. For example, the pharmaceutical industry uses the term equipment operational qualification while the International Laboratory Accreditation Conference (ILAC) uses the term equipment verification for confirming the instrument’s compliance with previously defined specifications. Frequently the terms validation and verification or validation and qualification are used interchangeably.

This compliance glossary defines terms most frequently used in the area of validation, calibration and qualification in analytical laboratories. Whenever available, official terms are used together with a reference to the source. The glossary is particularly useful in combination with the labcompliance search routine.

AB, CD, EF, GHI, JKLMN, OPQ, RST, UVXYZ

If you have any suggestion for a new term, please use the contact form. Thanks.

June 1, 1999

New FDA Compliance Policy Guide on e-Records-/signatures

The FDA has published a policy guide that provides the agency decisions on whether or not to pursue regulatory actions will be based on a case by case evaluation. Most important is the guidance on how to handle legacy systems that are not able to attain full compliance with Part 11. The FDA expects that firms using such legacy systems will begin taking steps to achieve full compliance. Firms should have a reasonable timetable for promptly modifying any system not in compliance to make them Part 11 compliant, and should be able to demonstrate progress in implementing their time table. For more information on 21 CFR Part 11, click here.

June 1, 1999

FDA Guidance on 'Computerized Systems Used in Clinical Laboratories' Released

The US FDA has Released a Guidance on 'Computerized Systems Used in Clinical Trials'. It can be used to learn about FDA's thinking on using computers in FDA regulated laboratories. Interesting are some paragraphs on electronic records
Free download from the FDA homepage

June 1, 1999

New Article on Validating HPLC methods

Validation of HPLC methods.
Author: Ludwig Huber, BioPharm, Vol 12, March 1999, Pages 64/66
Summary recommendations: The process of HPLC method's validation should demonstrate that the method is fit for its purpose. The validation should follow a plan that includes the scope of the method, the method performance characteristics and acceptance limits. Parameters usually examined in the HPLC method validation process are limits of detection and quantitation, accuracy, precision, selectivity/specificity, linearity, range and ruggedness. The article describes a strategy fot the validation and what exactly should be included in a validation report for submission to the FDA . Article will be available in June from public libraries.

June 1, 1999

Article: How Instrument Vendors Help with Accreditation

How an Instrument Manufacturer Helps with Accreditation and ISO Certification. Author: Ludwig Huber, submitted for publication in 'Accreditation and Quality Assurance for Laboratories'
To help users of equipment hardware and software to obtain laboratory accreditation and ISO certification, instrument manufacturers should develop a comprehensive compliance program for their products that includes product features, documentation and services for equipment validation and qualification. The article describes such a program that will help user firms to select vendors. The article is available from public libraries. Electronic draft version are available on the LabCompliance User Club

June 1, 1999

Searching LabCompliance by Keywords

A new routine allows to search for key words. This convenient tool is needed as more and more material is added to LabCompliance. The focused LabCompliance search program gives very specific answers to your question about compliance issues in analytical laboratories. You may be disappointed because unlike with other search engines you will not get hundreds of hits, but the ones you get are to the point and can be used right away. This saves you valuable time which you can spend for other things. Search