K-Patents PR-23 for K-Patents - Manual (Page 46)

Document/Revision No. IM-GB-PR23-ACP: Rev. 1.0 Effective: December 15, 2011
46
Appendix to the Instructions Manual PR-23
8.3 Test procedure
The Operational Qualification of the system is performed in accordance with a set plan in
which the following points are tested and documented sequentially:
● The required documents, measuring instruments, refractive index liquids, and required
cleaning materials are available
● Functional checks and verification of refractometer performance
● Functional checks have been made for the ancillary equipment.
The authorized official (client) hereby declares that the performance of the Operational
Qualification (OQ) for the Pharma Refractometer and Laboratory Test Cuvette have been
approved in accordance with this document/protocol. The authorized official is responsible
for all relevant matters in regard to the operational qualification.
Release by superior department:
Name:
Function:
Date:
Signature:
Initials:
Authorization by a higher-level authority is a prerequisite for carrying out the
qualification procedure. If no valid written authorization is available: Terminate the
Operational Qualification.
8.4 Authorized officiator
Selection of the individual authorized to carry out the Operational Qualification of the
Pharma Refractometer system should be in accordance to their relevant ability to undertake
the procedure. The authorized officiator’s signature is required for the next stage to validate
Date/Initials in the Operational Qualification log and reports.
Name:
Function:
Date:
Signature:
Initials: