Annex 4 Supplementary guidelines on good manufacturing practices

Format for an installation qualifi cation protocol and report (continued) a
Validation protocol _________ Installation Qualifi cation _________ Page _____ of _____
Title: ______________ Name and address of site: ________________________________
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Installation qualifi cation report
Results: _______________________________________________________________________
________________________________________________________________________________
_________________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________________
Conclusions:
________________________________________________________________________________
________________________________________________________________________________
__________________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________________
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________________________________________________________________________________
____________________________________________________________________________________________________________
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Report written by: _______________________________ Date: _______________________
QA approved by: _______________________________ Date: _______________________
a This format is used for training purposes and refl ects some of the possible contents for an installation qualifi -
cation protocol.
6. Operational qualifi cation
154
Note: see also “<strong>Supplementary</strong> <strong>guidelines</strong> on good manufacturing practices
(GMP): validation”.
6.1 Systems and equipment should operate correctly and their operation
should be verifi ed in accordance with an operational qualifi cation protocol.
6.2 Critical operating parameters should be identifi ed. Studies on the critical
variables should include conditions encompassing upper and lower operating
limits and circumstances (also referred to as “worst case conditions”).
6.3 Operational qualifi cation should include verifi cation of operation of
all system elements, parts, services, controls, gauges and other components.