IQ, OQ, PQ, PROCESS VALIDATION, PAT
EXAM QUESTIONS AND ANSWERS
What is qualification?
Identification of equipment attributes related to the performance of a particular
function or functions and allocations of certain limits or restrictions to those
attributes.
What is user requirement specification (URS)?
The URS defines what the user expects the system to do. Should be completed
before the functional specification (FS) is completed.
What is the content of a URS?
Introduction, system description, required functionality in (hardware and
software), interfaces, operational environment, appendices.
What is the functional requirement specification (FRS)?
The FRS describes what the system must be able to do.
What are the basic principles of qualification?
1.) Equipment must be installed correctly and in accord with an installation
plan.
2.) The requirements for calibration, maintenance and cleaning should be
reviewed and wrote up as SOPs.
3.) Operating requirements should be established and tests should be conducted
to ensure equipment is operating correctly.
4.) Operator training requirements pertaining to the equipment must be
documented.
What is installation qualification (IQ)?
IQ ensures that all system components are present and correctly installed when
compared to design specifications and URS.
What are the essential elements of installation qualification?
, Installation of equipment should follow well-defined plans. These plans should
be available and documented as equipment specifications, plant functional
specifications and piping & instrument diagrams (P&IDs). Changes to these
plans should be documented. It is also important that there is an
effective change management procedure in place.
How may supplies of equipment be checked prior to delivery?
A manufacturer may elect to undertake a pre-delivery check of the equipment at
the supplier's assembly facility (usually only for complicated/large pieces of
equipment). This should not substitute for IQ, but may complement it and
reduce the scope of IQ checks.
How may supplied equipment be checked at user site?
IQ requires a formal and systematic check of all installed equipment against the
supplier's specifications and any additional criteria required. All equipment,
gauges and services should be given a reference number and a check
conducted that the installed equipment has been installed in accord with the
approved P&ID.
What is a preventative maintenance document and when should it be prepared?
A preventative maintenance document should be prepared at IQ stage. The
equipment should be documented and added to the preventative maintenance
schedule of the pharmaceutical manufacturer.
When should cleaning documentation be prepared/finalized?
Cleaning documentation should be drafted during IQ stage, finalized during
experience/observation at OQ stage and finally verified at the PQ stage.
What is operational qualification (OQ)?
OQ ensures that each function performs as defined in the functional
specification. It ensures the system is 'built right', operates as expected, and
appropriate fail-safe measures are functional.
What are the essential elements of operational qualification?
Where applicable, simulated product may be used to conduct OQ. Critical
variable studies must be included, which measure the systems upper and lower
EXAM QUESTIONS AND ANSWERS
What is qualification?
Identification of equipment attributes related to the performance of a particular
function or functions and allocations of certain limits or restrictions to those
attributes.
What is user requirement specification (URS)?
The URS defines what the user expects the system to do. Should be completed
before the functional specification (FS) is completed.
What is the content of a URS?
Introduction, system description, required functionality in (hardware and
software), interfaces, operational environment, appendices.
What is the functional requirement specification (FRS)?
The FRS describes what the system must be able to do.
What are the basic principles of qualification?
1.) Equipment must be installed correctly and in accord with an installation
plan.
2.) The requirements for calibration, maintenance and cleaning should be
reviewed and wrote up as SOPs.
3.) Operating requirements should be established and tests should be conducted
to ensure equipment is operating correctly.
4.) Operator training requirements pertaining to the equipment must be
documented.
What is installation qualification (IQ)?
IQ ensures that all system components are present and correctly installed when
compared to design specifications and URS.
What are the essential elements of installation qualification?
, Installation of equipment should follow well-defined plans. These plans should
be available and documented as equipment specifications, plant functional
specifications and piping & instrument diagrams (P&IDs). Changes to these
plans should be documented. It is also important that there is an
effective change management procedure in place.
How may supplies of equipment be checked prior to delivery?
A manufacturer may elect to undertake a pre-delivery check of the equipment at
the supplier's assembly facility (usually only for complicated/large pieces of
equipment). This should not substitute for IQ, but may complement it and
reduce the scope of IQ checks.
How may supplied equipment be checked at user site?
IQ requires a formal and systematic check of all installed equipment against the
supplier's specifications and any additional criteria required. All equipment,
gauges and services should be given a reference number and a check
conducted that the installed equipment has been installed in accord with the
approved P&ID.
What is a preventative maintenance document and when should it be prepared?
A preventative maintenance document should be prepared at IQ stage. The
equipment should be documented and added to the preventative maintenance
schedule of the pharmaceutical manufacturer.
When should cleaning documentation be prepared/finalized?
Cleaning documentation should be drafted during IQ stage, finalized during
experience/observation at OQ stage and finally verified at the PQ stage.
What is operational qualification (OQ)?
OQ ensures that each function performs as defined in the functional
specification. It ensures the system is 'built right', operates as expected, and
appropriate fail-safe measures are functional.
What are the essential elements of operational qualification?
Where applicable, simulated product may be used to conduct OQ. Critical
variable studies must be included, which measure the systems upper and lower
