EDQM提供的HPLC验证资料.pdf

QUALITY ASSURANCE DOCUMENT QUALIFICATION OF EQUIPMENT ANNEX 1: QUALIFICATION OF HPLC EQUIPMENT Full document title and Qualification of Equipment reference Annex 1: Qualification of HPLC Equipment PA/PH/OMCL (07) 17 DEF Document type Guideline Legislative basis Date of first adoption May 2005 Date of original entry June 2005 into force Date of entry into force February 2007 of revised document Previous titles/other This document replaces document PA/PH/OMCL (06) 85 DEF references Custodian The present document was elaborated by the OMCL Network/ Organisation EDQM of the Council of Europe Concerned Network GEON ANNEX 1 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” QUALIFICATION OF HPLC EQUIPMENT Introduction The present document is the first Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the HPLC equipment qualification process. The core document contains the general introduction and the Level I and II of qualification, common to all type of instruments, and the present annex contains HPLC instrument-related recommendations on parameters to be checked and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry out these checks. When qualifying HPLC equipment, it should be noted that it is acceptable to check at Level III and IV several of the mentioned parameters at the same time in a combined test procedure (e.g. “overall” system performance test giving information on peak area precision, retention time precision, gradient reproducibility, etc).