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Labcompliance News, February 2006

February 1, 2006

92 Slides Presentation on API Inspections

 Dr. Robert Horan from FDA's Pharmaceutical Inspectorate, New York District, gave presentation on API inspections at FDA's cGMP China training. Dr. Horan gave a lot of examples on inspection findings. Deviations have been related to the Quality System (17 slides), Laboratory Systems incl. OOS ( 27 slides), Facilities & Equipment (21 Slides), Production Systems (11 slides), material systems and Packaging&Labeling. To download the 92 slides presentation, click here.

February 13, 2006

Lack of IQ/OQ/PQ Documentation Cited in FDA Warning Letter

The FDA expects installation and operational qualification of equipment and settings for performance qualification to be documented . This was confirmed through a warning letter from December 2, 2005. The letter stated: The equipment lacks documentation of installation and operation qualification of equipment and the company failed to document settings used for the Performance Qualification. The company was also cited for failing to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts. . Recommendations for FDA compliant equipment qualification can be found in the USP draft chapter "Analytical Instrument Qualification". To learn more about this chapter, click here.

February 2005

New version of the Macro&Spreadsheet Package Released

Labcompliance has just released a new version of it's popular Macro&Spreadsheet Quality package. The package helps to reduce spreadsheet errors and to comply with FDA and other regulations. New SOPs and templates, a new audio seminar and FDA's new Laboratory Information bulletin Spreadsheet design, Verification and Validation: Use and storage of single user workbook files in the US FDA Laboratories are just a few examples for new additions. For more information and ordering the package, click here.