GMP News No. 321
GMP News 18 June 2003 |
FDA
Presents Its Analysis |
It usually takes some time before one can access the official FDA statistics for the previous fiscal year (October 2001 - 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 of them ended up with the issuing of a 483. The analysis of the 483s is very interesting since they themselves cannot be viewed on the Internet. The topical focus of the 483s already follows the structure of FDA's
new System-based Inspections. Most of the observations refer to
facilities/equipment, laboratory (21% each) and the quality system (20%).
Production (18%) ranks 4th. The material system (12%) and
packaging/labelling (5%) rank 5th and 6th respectively. |
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Illustration 1 35% of the 477 observations made in laboratories were of a general
nature. Inadequate records/SOPs rank 2nd with 27% and the stability
programme ranks 3rd with 21% (cp. illustration 2). |
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Illustration 2 466 observations noted on a 483 referred to the facilities/equipment
system. In this area, the worst offender was cleaning/maintenance with
28%, closely followed by inadequate records/SOPs (25%), which rank 2nd
again. Equipment design/qualifications ranks 3rd with 17%. See
illustration 3 for further details. |
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Illustration 3 450 observations concern the quality system. 30% of them find fault
with the documentation, 28% disapprove of the QA conduct, and 25%
criticise the failure investigation/OOS. What is interesting is the fact
that these data only encompass the period from February to July 2002 (see
illustration 4)! |
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Illustration 4 Among the 394 observations regarding the productions system, inadequate
documentation is again in the lead (39%). Process/design validation (24%)
ranks 2nd and product/process control (21%) ranks 3rd. For further details
see illustration 5. |
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Illustration 5 As many as 42% of the 294 observations regarding the material system
censure the components/closure integrity. Inadequate records/SOPs come 2nd
with 21% and process water, 3rd with 17% (cp. illustration 6). |
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Illustration 6 The last system (packaging and labelling) gave rise to 104
observations. Process and controls was referenced in 47% of these
observations, which is the highest percentage of all systems. Inadequate
records/SOPs (36%) and training/qualification (17%) rank 2nd and 3rd
respectively (see illustration 7). |
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Illustration 7 These 483 findings are correspondingly reflected in the analysis of findings in Warning Letters (cp. GMP News of 2 April 2003). In this context we would like to recommend you the following GMP events, which deal with important FDA topics: , Vienna, Austria, 17-19 September 2003Author: |