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Labcompliance News, February 2004

Feb 28, 2004

Model Standard Operating Procedures: New Service from Labcompliance

Starting February 1, 2004, Labcompliance offers model SOPs for regulated industry. They can be used as a starting point for further customization, they save time and can increase confidence for inspections. They are available in PDF format or in Microsoft word with hyperlinks for easy of use. For a list with titles and ordering, click here.

Feb 10, 2004

New Publication: Compliance with Multi-Compendial Testing Requirements for Excipients: Challenges and Strategies

The requirement for pharmaceutical manufacturers to test raw materials prior to their use in drug products is clearly established by current Good Manufacturing Practices (cGMPs). Excipient testing must also satisfy regulatory requirements to support the use of a drug product in many countries throughout the world. Although many countries have their own compendia, including Britain, France, Germany, India, and China, it is generally recognized that the major compendia are the United States Pharmacopeia - National Formulary (USP-NF), European Pharmacopoeia (Ph.Eur.), and Japanese Pharmacopoeia-Japanese Pharmaceutical Excipients (JP-JPE). One of the many challenges facing global pharmaceutical manufacturers is ensuring compliance with multi-compendial testing requirements for excipients, since there may be significant differences in the monographs for the same excipient in the USP-NF, Ph.Eur., and JP-JPE.. This article from J. Mark Wiggins, Regulatory and Analytical Sciences, Merck and Co., Inc., discusses several approaches to demonstrate multi-compendial conformance.

Feb 10, 2004

Inadequate Excel Spreadsheet Validation Cited in a Recent FDA Warning Letter

During an inspection in Denmark FDA inspectors found significant deviations related to software validation. Result was a warning letter. For example, the firm used Microsoft 2000 Excel software in manufacturing. According to the warning letter an MS 2000 Excel spreadsheet has not been validated for the purpose of generating a worksheet for formulation of reagents. In addition, no documentation was found to establish or verify corrections made to the program, and as a result of all this, the spreadsheet "was seen to give incorrect data". Missing or inadequate validation of Excel and other spreadsheets comes up frequently in Warning Letters and 483 inspectional observations. Labcompliance has mentioned this several times and gives advice in info-notes. Usersclub members can download the warning letter, non members can preview excerpts.