Annex 4 Supplementary guidelines on good manufacturing practices

Format for an operational qualifi cation protocol a
Validation protocol _________ Operational Qualifi cation ________ Page _____ of _____
Title: ______________ Name of Facility: _________________________________________
________________________________________________________________________________
Validation Protocol # ____________________ Operational Qualifi cation _______________
Title ____________________________________________________________________________
________________________________________________________________________________
Protocol written by _______________________________________________________________
Departmental Approval by ____________________________________ Date ____________
QA Approval by ______________________________________________ Date ____________
Objective
To determine that the system/equipment operates according to specifi cations, and to
record all relevant information and data to demonstrate that the system/equipment functions
as expected.
Scope
To be performed after installation, modifi cation or relocation, after the Installation Qualifi -
cation has been completed.
Responsibility
Person responsible for operating the system/equipment will perform the qualifi cation and
record the information.
The supervisor will supervise the study, verify the completion of the records, write the
deviation report and the Operational Qualifi cation (OQ) Report.
Qualify Assurance will review and approve the OQ protocol and report.
a This format is used for training purposes and refl ects some of the possible contents for an operational qualifi -
cation protocol.
6.4 There should be documented records for the verifi cation of operation
(operational qualifi cation report) to indicate the satisfactory operation.
6.5 Standard operating procedures for the operation should be fi nalized
and approved.
6.6 Training of operators for the systems and equipment should be provided,
and training records maintained.
6.7 Systems and equipment should be released for routine use after
completion of operational qualifi cation, provided that all calibration, cleaning,
maintenance, training and related tests and results were found to be
acceptable.
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