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Labcompliance News, February 2001

Feb 13, 2001

New Bioavailability/Bioequivalence Guide from the FDA

Studies to measure bioavailability (BA) and/or establish bioequivalence (BE) of a product are important elements in support of INDs, NDAs, ANDAs, and their supplements. The FDA has released an industry guidance document on BA and BE Studies for Orally Administered Drug Products. It is intended to provide recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for orally administered drug products in investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and their supplements. This guidance addresses how to meet the BA and BE requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration.

Feb 14, 2001

What does that mean: "Use of Device Checks" in 21 CFR Part 11?

Paragraph 11.10 (h) of 21 CFR Part 11 requires the "Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction". There is a lot of uncertainty on what this really means. A new publication from Bob McDowal brings light in this area. Using many examples from chromatographic laboratories, the article explains what it means and how to implement device checks. You could be surprised to find out that you may already use device checks without realizing it.

Feb 14, 2001

EPA Proposes New Rule for Electronic Reporting and Electronic Records

The United States Environmental Protection Agency has released the proposed Cross-Media Electronic Reporting and Record-keeping Rule (CROMERRR). This will allow electronic reporting to EPA by permitting the use of electronic document receiving systems to receive electronic documents in satisfaction of certain document submission requirements in EPA’s regulations. The proposed rule sets forth the conditions under which EPA will accept the submission of electronic reports and other electronic documents, as well as the maintenance of electronic records, by regulated entities, as satisfying requirements under this Title to submit reports or other documents, or to keep records. Electronic reporting will be voluntary. There will be no requirement to report to EPA electronically, but if reports are submitted to EPA electronically, CROMERRR will apply. The criteria set forth in the proposed rule are intended to be consistent with criteria set forth for electronic document systems in other relevant regulations, such as FDA’s criteria in 21 CFR Part 11.