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Im Juli 2006 hat die FDA einen Warning Letter
veröffentlicht, bei dem die fehlende GMP-Compliance bei der HPLC-Analytik
einer der zentralen Beanstandungspunkte war:
Hier die wichtigsten Inhalte des Warning Letters bezüglich HPLC:
- The reference standard injection following assay and content
uniformity testing of ... failed to show any peaks due to a leaking
column. There was no documented investigation of this deviation, there
was no assessment of the impact of the leaking column on the … analysis
or any other analysis conducted with the same column, and the … samples
were not reinjected.
- There was no documented investigation regarding HPLC malfunctions
requiring external repair. Both HPLC … and … required repair in June
2005; however there is no documentation regarding whether the
malfunctions impacted any analysis, and if so, what the corrective
actions were regarding those analyses.
- Laboratory records fail to include the initials or signature of the
person who performs each laboratory test. Specifically, laboratory
analysis records for analyses performed by HPLC … and … do not indicate
which analyst performed the injections.
- Failure to maintain complete records of any modification of an
established method employed in testing. Specifically, the records of
laboratory methods stored in the computer system do not include the
identity of the person initiating method changes.
- Appropriate controls are not exercised over computers or related
systems to assure that changes in analytical methods or other control
records are instituted only by authorized personnel. Specifically: Due
to the common password and lack of varying security levels, any analyst
or manager has access to, and can modify any HPLC analytical method or
record. Furthermore, review of audit trails is not required.
Dieser aktuelle Warning Letter zeigt, dass die HPLC-Analytik bei
FDA-Inspektionen nach wie vor im Fokus steht und im Einzelfall sehr
detailliert überprüft wird.
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