26/27 January 2021
GMP News No. 321
GMP News 18 June 2003 |
FDAPresents Its Analysis |
It usually takes some time before one canaccess the official FDA statistics for the previous fiscal year (October2001 - October 2002). This has indeed happened only recently,so that we can present you with a current selection of data. In Fiscal Year 2002, the FDA conducted 281 inspections abroad. 185 ofthem ended up with the issuing of a 483. The analysis of the 483s isvery interesting since they themselves cannot be viewed on the Internet. The topical focus of the 483s already follows the structure of FDA'snew System-based Inspections. Most of the observations refer tofacilities/equipment, laboratory (21% each) and the quality system (20%).Production (18%) ranks 4th. The material system (12%) andpackaging/labelling (5%) rank 5th and 6th respectively. |
Illustration 1 35% of the 477 observations made in laboratories were of a generalnature. Inadequate records/SOPs rank 2nd with 27% and the stabilityprogramme ranks 3rd with 21% (cp. illustration 2). |
Illustration 2 466 observations noted on a 483 referred to the facilities/equipmentsystem. In this area, the worst offender was cleaning/maintenance with28%, closely followed by inadequate records/SOPs (25%), which rank 2ndagain. Equipment design/qualifications ranks 3rd with 17%. Seeillustration 3 for further details. |
Illustration 3 450 observations concern the quality system. 30% of them find faultwith the documentation, 28% disapprove of the QA conduct, and 25%criticise the failure investigation/OOS. What is interesting is the factthat these data only encompass the period from February to July 2002 (seeillustration 4)! |
Illustration4 Among the 394 observations regarding the productions system, inadequatedocumentation is again in the lead (39%). Process/design validation (24%)ranks 2nd and product/process control (21%) ranks 3rd. For further detailssee illustration 5. |
Illustration5 As many as 42% of the 294 observations regarding the material systemcensure the components/closure integrity. Inadequate records/SOPs come 2ndwith 21% and process water, 3rd with 17% (cp. illustration 6). |
Illustration6 The last system (packaging and labelling) gave rise to 104observations. Process and controls was referenced in 47% of theseobservations, which is the highest percentage of all systems. Inadequaterecords/SOPs (36%) and training/qualification (17%) rank 2nd and 3rdrespectively (see illustration 7). |
Illustration7 These 483 findings are correspondingly reflected in the analysis offindings in Warning Letters (cp. GMPNews of 2 April 2003). Author: |