GMP News No. 391
23 February 2004
GMP/FDA Requirements on HPLC Systems in the Lab
In July 2003 the Gold Sheet published a Summary Report on AAPS Instrument Qualification Workshop (March 2003). This workshop was co-sponsored by ISPE and the International Pharmaceutical Association (FIP). The aim of this meeting, including FDA representatives, was to establish common terminology for Analytical Instrument Qualification (AIQ).
It was considered appropriate that the DQ, IQ, OQ, PQ terms for qualification although these terms were found confusing for AIQ should be continued and that the AIQ process should be defined around them, since these terms have already found their place in the validation (qualification) terminology.
Key requirements for IQ, OQ and PQ were defined. For instance the term Operational Qualification (OQ) is defined and explained as:
Performance Qualification is defined as on-site testing that verifies consistent and proper operation of the analytical instrument or system, according to a specification appropriate for its routine use. These tests check the maintenance and calibration of the instrument System. Suitability checks can supplement but not replace the functional checks for PQ!
Furthermore, software validation was probably the most controversial issue handled at this AAPS workshop. A white paper will be published based on the workshop discussions.
Equipment Qualification (including the a.m. AIQ proposals) and Software Validation are two of the main topics of the Conference of the European Compliance Academy Successful HPLC Management in a GMP-/FDA-Regulated Environment. This conference takes place on 31 March and 1 April 2004 in Barcelona, Spain followed by a Post-Conference Workshop on Validation of Chromatography Data Systems. Click here to find the complete programme.
2) HPLC in Human Drug cGMP Notes
In earlier issues of FDA's Human Drug CGMP Notes there were two questions dealing with HPLC, which might be interesting although they are not brand-new:
The first question was in March 1996:
The answer was: "The agency has no specific policy on recycled HPLC solvents . Therefore it would be acceptable to use recycled solvents which do not interface with analytical results or equipment operation."
The second question was in September 1997:
Russ Rutledge (FDA) answered to this question:
One lecture at the international HPLC Conference Successful HPLC Management in a GMP-/FDA-Regulated Environment in Barcelona will cover Out of Specification HPLC Results. Click here for the complete programme.
3) HPLC in FDA Warning Letters
FDA Inspections often cover HPLC details as you can see from the below listed FDA Warning Letter citations:
At the ECA Conference Successful HPLC Management in a GMP-/FDA-Regulated Environment, which takes place at 31 March and 1 April 2004 in Barcelona, emphasis will be on latest enforcement issues and current FDA thinking including the revised interpretation of part 11 requirements. The invitation brochure for this conference can be found here.
Dr Günter Brendelberger