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GMP News No. 408
GMPNews 19 April 2004 |
Top Ten of 483 Findingsby the FDA in Fiscal Year 2003 |
However,the statistics for FY 2003 (October 2002 - October 2003) have already beenpublished at the GMP Conference held in Athens (Georgia, USA) from 15 to18 March 2004. Here, we would like to present you with some of the data. In FY 2003, the FDA conducted 259 inspections abroad. 162 of them endedwith the issue of a "483." A 483 is a form on which the FDAinspector documents his or her inspection findings. The frequency of complaints can also be analysed via the warningletters. Such a - very comprehensive - analysis is carried out every yearby CONCEPT HEIDELBERG. This may lead to a different order of findings,which is due to 2 reasons:
For 2004, the FDA has planned to conduct 582 inspections, 210 of whichwith regard to "DrugQuality GMPs." The FDA's analysis of the 483s is very informative, as these forms arenot available on the Internet. The analysis results in the followingclassification: 10th place "PRODUCTION RECORD REVIEW" (21 CFR 211.192):referenced on 141 of the 483 forms 9th place "COMPLAINT PROCEDURES are not established orfollowed" (21 CFR 198 (a)): referenced on 142 of the 483 forms 8th place "LABORATORY CONTROLS" (21 CFR 211.160 (b)): referencedon 163 of the 483 forms 7th place "PERSONNEL QUALIFICATIONS" (21 CFR.25 (a)): referencedon 166 of the 483 forms 6th place "VALIDATION" (21 CFR 211.110 (a)): referencedon 173 of the 483 forms 5th place "Failure to maintain complete and accurate BATCHPRODUCTION AND CONTROL RECORDS" (21 CFR 211.188): referenced on 178 of the 483 forms 4th place "TESTING AND RELEASE FOR DISTRIBUTION" (21 CFR211.165 (a)): referenced on 183 of the 483 forms 3rd place "WRITTEN PROCEDURES FOR PRODUCTION AND PROCESSCONTROLS" (21 CFR 211.100 (a)): referenced on 185 of the 483 forms 2nd place "RESPONSIBILITIES OF THE QUALITY CONTROL UNIT" (21CFR 211.22 (d)): referenced on 247 of the 483 forms 1st place "FAILURE TO FOLLOW AND/OR DOCUMENT WRITTEN PRODUCTION ANDPROCESS CONTROL PROCEDURES" (21 CFR 211.100 (b): referenced on 317 of the 483 forms |
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