OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT PA/PH/OMCL (07) 11 DEF CORR QUALIFICATION OF EQUIPMENT ANNEX 3: QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETERS Full document title and reference Qualification of Equipment Annex 3: Qualification of UV-Visible spectrophotometers PA/PH/OMCL (07) 11 DEF CORR Document type Guideline Legislative basis The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System audits of OMCLs Date of first adoption May 2007 Date of original entry into force July 2007 Date of entry into force of revised document December 2007 Previous titles/other references This document replaces document PA/PH/OMCL (07) 11 DEF Custodian Organisation The present document was elaborated by the OMCL Network/EDQM of the Council of Europe Concerned Network GEON PA/PH/OMCL (07) 11 DEF CORR - OMCL Gu ideline on Qu alification of UV-Visible spectrophotometers (Annex 3)December 2007Page 1 of 15 ANNEX 3 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETERS Introduction The present document is the third Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the UV-Visible spectrophotometer qualification process. The core document contains the Introduction and general forms for Level I and II of qualification, which are common to all type of instruments. For UV-Visible spectrometers, an example has been added to give instrument-specific proposals that may be used in combination with the general requirements presented in the core document “Qualification of Equipment”, when drawing up a Level...
