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Labcompliance News, January 2006

 January 27, 2006

EPA publishes the Final version of CROMERRR in the Federal Register

The United States Environmental Protection Agency has released the final Cross-Media Electronic Reporting and Record-keeping Rule (CROMERRR). The regulation provides the legal framework for electronic reporting under all of EPA's environmental regulations. It provides a uniform, technology-neutral framework for electronic reporting across all EPA programs; allows EPA programs to offer electronic reporting as they become ready (without any additional rule-making beyond CROMERRR); It also provides states with a streamlined process – together with a uniform set of criteria – for approval of their electronic reporting implementations for all their EPA-authorized programs; and ensures that electronic reporting under EPA and EPA-authorized state programs does not compromise the enforceability of environmental programs. The first draft has been published in 2001 and at that time was considered FDA's equivalent of Part 11. The new document has some good recommendations on how to deal with electronic records in regulated environments.

January 2, 2006

EMEA: Questions & Answers on Audits of Active Substances Manufacturers

Since EMEA has released the "Guidance to conduct inspections at the premises of Manufacturers of Active Substances used as starting materials" many questions came up about this guidance. EMEA has set up a website to answer frequently asked questions about how manufacturing authorization holders should fulfill their obligations, e.g., if audits performed by a third party are acceptable and and if an audit of an active substance supplier is necessary if the supplier has been inspected by an inspectorate from an EEA member state and a valid GMP certificate is available.

January 2, 2006

Recording Pass/Fail not Enough for Testing, FDA Warning Letter Says

The FDA expects quantitative test results, just recording "Pass" or "Fail" is not enough. This was confirmed through a warning letter from November 22, 2005. The letter stated: The test results were not documented in sufficient details to demonstrate how the power unit passed its finished product testing. The test results were simply recorded as either "Pass" or "Fail". For example, your firm failed to explain and document quantitative test results and specific acceptance criteria for the power unit's test parameters, such as the electrode temperature, safety alarm functions, current and voltage output, elapsed timer, and stimulation counter. Furthermore the FDA noticed: The "Pass/Fail" portion of the power unit testing was filled out before the power unit testing was actually conducted. Moreover the company failed to provide documentation explaining whether the firm or the specification developer has conducted and documented any risk analysis. The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.  To learn more about developing FDA compliant test protocols, click here.