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Labcompliance News, August 2006

August 20, 2006

New Solutions from Labcompliance

Labcompliance offers a variety of new solutions that help visitors to learn about theory and practice of validation and compliance.

Reference Papers help to understand regulatory and business requirements and to develop strategies on how to approaches requirements in your company. They are available for computer validation, equipment qualification, understanding and implementation of part 11, method validation and other topics.

Standard Operation Procedures help to implement requirements as easy to follow step by step procedures. They are also ideally suited to train staff to understand and implement requirements. Currently there are 30 SOPs available, e.g., for computer validation, risk based qualification of networks, control and documentation of planned and unplanned changes, handling failure investigation, FDA inspections, method validation, development of test scripts and design and validation of spreadsheet applications.

Gap Analyses and Checklists are ideally suited to prepare your organization, department and people for inspections. They are available for GMP and GLP regulations, for spreadsheets, for laboratory inspections and for network qualification and system validation.

Templates and Examples help to quickly implement procedures. They are available for development of user requirement specification of computers and equipment, for functional testing of Excelâ„¢ spreadsheets and others. 

August 20, 2006

"Electronic Raw Data Not Saved" Cited in FDA Warning Letter

This Warning Letter is not from 2000/2001 but from 2006. The FDA did write the letter after inspecting a stability testing laboratory. The letter reads: "The operating parameters were maintained with the relevant ( ). However, the ( ) electronic raw data was not saved. According to the director of Quality Assurance ( ) began saving ( ) electronic raw data just recently at the beginning of February 2006. However, that was not observed during the inspection." This is a Part11 issue. However, according to FDA's policy there is no reference to Part 11 but to the predicate rule, in this case 21 CFR 211. Labcompliance has published an article with more background information and recommendations for record retention of hybrid systems. The letter furtherer stated that "The Quality Control Unit lacks adequate laboratory resources (personnel, equipment) for conducting stability testing of drug products" and "Storage condition for samples retained for stability testing are not adequately documented". The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.

August 20, 2006

Labcompliance Welcomes LIMSfinder.com

We at Labcompliance would like to welcome LIMSfinder.com as one of our premier sponsors. LIMSfinder is the most comprehensive online, interactive magazine devoted to Laboratory Information Management Systems (LIMS) and other Laboratory Informatics Solutions. LIMSfinder is simply the best resource for Information Technology in the Laboratory. LIMSfinder's mission is to make the job of finding LIMS and other laboratory software quick, easy, and informative. www.limsfinder.com

August 20, 2006

How Written SOPs Facilitate Processes in a Preformulation Physical-Pharmacy Laboratory

This new article authored by Frank A. Chrzanowski, Ph.D., demonstrates the applicability and advantages of written SOPs as a means of facilitating the operation of a pre-formulation physical-pharmacy laboratory (PPPL). Arguments for and against are presented with examples from the author's experience. When adequately followed written SOPs provide for better laboratory operation and strict compliance in areas related to regulatory findings. The case for written SOPs for a PPPL could also be applied to other pharmaceutical development laboratories.