Regulatory Roundup: FDA Announced Upcoming Part 11 Inspections; And More.

Jul 15, 2010
By Pharmaceutical Technology Editors

The US Food and Drug Administration announced last week that it will be “conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of [21 CFR] Part 11.” The agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the 2003 Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application. (See related blog post.)

FDA also issued a new Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 13. This particular annex harmonizes the analytical procedures used for bulk density and tapped density of powders across the US, Europe, and Japan. ICH adopted Annex 13 in June 2010. FDA has published other harmonized Q4B annexes as guidance’s over the past year, including Annex 5 Disintegration Test, 7 Dissolution Test, 8 Sterility Test, 9 Tablet Friability, and 10 Polyacrylamide Gel Electrophoreses.


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