17.10.2006

HPLC in FDA Warning Letter

GMP News No. 818

GMP News
17 October 2006

In July 2006, the FDA published a warning letter in which one of the main points of criticism was non-GMP compliance of HPLC analysis.

The most important contents of the warning letter regarding HPLC were:

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.

This recent warning letter shows that HPLC analysis is one of the focal points in FDA inspections and that the inspectors sometimes have a very close look at it.

For this reason, the European Compliance Academy repeats the GMP Education Course "Successful HPLC Management in a GMP-/FDA-Regulated Environment" in Prague on 22-23 November 2006. Additionally, it offers the Post-Course Workshop "Maintaining the Validation Status of CDS" on 24 November 2006.

Topics that will be covered are:

Sample preparation for chromatography
GMP-compliant HPLC documentation
HPLC equipment qualification
HPLC method transfer
Method development and validation
System Suitability Testing - Pharmacopoeial requirements
Risk-based approaches to computer validation of HPLC software

The subsequent Workshop focuses on change control, configuration management (system upgrades, service packs, etc.), backup, recovery and periodic review. All participants will receive a checklist for a periodic review.

Author:
Dr Günter Brendelberger
On behalf of ECA

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