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Every now and then, we receive inquiries concerning details of our analysis of
the FDA Warning Letters (see GMP
News of 18 June 2002 on Warning Letter Report).
Up to now we have not published such
details. However, now we intend to publish detailed data regarding
specific complaints in the ECA Members Area time after time. This
compilation will render it unnecessary to search all Warning
Letters for specific deficiencies (e.g. OOS). We have sorted out the relevant
text passages for you. In the months to come, the following evaluations will be published (each
time after prior announcement) for ECA members only:
- 21 CFR 211.100 (Written procedures;
deviations)
- 21 CFR 211.160 (Laboratory controls,
general requirements)
- 21 CFR 211.165 (Testing and release
for distribution)
- 21 CFR 211.166 (Stability testing)
- 21 CFR 211.188 (Batch production and
control records)
- 21 CFR 211.192 (Production record
review)
- 21 CFR 211.22 (Responsibilities of quality
control unit)
- 21 CFR 211.25 (Personnel
qualifications)
- 21 CFR 211.67 (Equipment cleaning and
maintenance)
- 21 CFR 211.84 (Testing and approval or
rejection of components, drug product containers, and closures)
The following freely-available example concerning
complaints/complaint handling demonstrates how the system works. Here you can see the evaluation results
for 21 CFR 211.198 (Complaint Handling).
Writer:
Oliver Schmidt
CONCEPT HEIDELBERG
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