6.

E Installation Qualification (IQ)

Up3/2017 Thomas Peither, Ulrike Reuter, Rainer Röcker

Here you will find answers to the following questions:

● What is meant by the term “IQ”?

● Which regulatory requirements should be upheld?
● Which aspects are checked during the IQ?
● What is the scope of the technical documentation?
● Where does the IQ fall in the course of the project execution?
● What should be reflected during the execution and documentation of the IQ?

6.E.1 Purpose and content of an Installation Qualification

An Installation Qualification is the provision of documented evidence that the equipment meets the predefined
requirements with regard to identity, installation, guideline conformity and documentation (see Figure 6.E-1).

Figure 6.E-1 Definition of an IQ according to EU GMP Guidelines, Annex 15

Definition IQ (EU GMP Guidelines, Annex 15)

Installation Qualification (IQ)

The documented verification that the facilities, systems and equipment, as installed or modified, comply with the
approved design and the manufacturer's recommendations.

During the Installation Qualification the equipment is checked for conformity with the User Requirements and that the
installation has been performed properly. Installation Qualification comprises therefore the identification of the complete
equipment supplied and the confirmation that all components of the delivery meet the specifications laid out in the
Functional Design Specification during the planning phase.

According to Annex 15, an IQ should include at least the following checks:

● Check that all components, instruments, equipment, piping and services are installed according to the technical
drawings and specifications;
● Check that the equipment has been installed correctly in accordance with the pre-defined criteria;
● Record and compile the operating, production and maintenance instructions provided by the supplier;
● Calibrate all instruments;
● Verify materials of construction.
6.E.2 Technical documentation
In this qualification phase special consideration is given to the technical documentation, which is to be provided by the
supplier. The scope of the documentation should be described precisely during the Design Qualification (see Chapter
6.D Design Qualification (DQ) and Chapter 4.E Technical documentation).

In the interest of good customer/supplier relations it is recommended to define the delivery date for the technical
documentation precisely in advance. For equipment projects it makes sense to reflect the delivery time point of the
technical documentation within the so-called Milestone Plan. At the latest, when the FAT is conducted the technical
documentation should be provided for review, even if it is in the form of a draft. Since checking the technical
documentation is part of the FAT, there is typically a financial pressure present which the customer can exert, as
successful completion of the FAT is typically a condition for the 2nd installment payment. Often this payment may be as
much as 40–50% of the total purchase price.

It goes without saying that the installation instructions are an essential part of the technical documentation. If not
provided, the operator cannot set up the equipment. The necessary utilities and their required supply capacities are also
defined here. While the FDS describes the supplier’s answer to the URS, the actual specifications i.a. are part of the
technical documentation and reflect the executed equipment design (as-built).

Figure 6.E-2 presents the scopeof the technical documentation in an overview.

Figure 6.E-2 Possible scope of technical documentation from supplier

Technical documentation provided by the supplier

● Transport confirmation
● Equipment descriptions
● Operating instructions in specified local language
● Functional schematic
● Installation and layout plans
● P&ID schematics
● Air duct schematic drawings
● Energy and utility supply requirements (including operating parameters)
● Technical data sheets
● Specifications/certificates for lubricants, adjuvants and other operating media
● Material certificates for product-contact parts
● Environmental conditions
● Alarm concept (alarms and alerts)
● Defined and valid backup & restore procedures
● Maintenance instructions (including intervals in operating hours)
● Cleaning instructions
● Terminal diagrams
● Pneumatic diagrams
● Exploded assembly drawings
● Parameter lists
● Calibration instructions and the manufacturer’s calibration certificate
● Certificate of conformity
● List of standard software modules used
● List of modules programmed for the customer application
● User management concept
● Audit trail

After acceptance testing of the equipment, the technical documentation should reflect the as-built status. Any changes
made during the design, manufacture, assembly and commissioning phases must be reflected in the documentation
and thus be updated accordingly.

6.E.3 Installation Qualification within the project schedule

Installation Qualification is performed after delivery of the equipment in parallel to the actual installation and assembly
on site. In the case of pre-assembled equipment, the Installation Qualification can be performed at the supplier’s site, at
least partially (example: water treatment units). This also holds for cases in which the parts cannot be retested after
assembly (e.g. material testing of heat exchanger tubes or material numbers which are covered by insulation).

For the purpose of economy, further tests may also be performed during the FAT, e.g. the checking of the parts labelling
or the assembly of the electrical cabinet compared to the wiring diagrams. These tests can then also be included in the
IQ and do not need to be performed a second time.

Depending on the type of equipment delivered, the following steps in the IQ can be scheduled to be done earlier:

● Factory Acceptance Test, FAT:

Acceptance testing at supplier site (optional)
● Site Acceptance Test, SAT:
Acceptance testing performed after delivery, installation and commissioning of the equipment at the customer’s site.
The equipment must be fully functional and meet all functional specification requirements. Furthermore, commercial
and contractual requirements must be regarded: In general the SAT is linked with a payment installment; the transfer
of liability also plays a significant role. The equipment becomes property of the customer at this point. During the SAT
all the approved features of items to be delivered (as detailed in the URS and FDS) are to be checked while also
reflecting any changes initiated in the meantime.

The protocols for these tests should also be included in the complete documentation of the IQ.

As a prerequisite for OQ it is required that the IQ be closed out successfully. In practice, however, a full completion of
the IQ seldom ever happens, rather there are typically open items remaining. The following procedure has become well
accepted:

● Open items at the completion of IQ should be assessed and classified (critical/not critical).
● If there are open items which have been classified as critical, these must be corrected first.
● Once there are no more incomplete critical items left, the OQ can be started.
● Parallel to the execution of the OQ it is necessary to ensure that work on the open non-critical items remaining from
the IQ is completed.

The chronological order of commissioning (project milestone) and Installation Qualification (qualification milestone)
subsequent to the installation can not be defined in general for all cases. Even if a carefully performed Design
Qualification would theoretically lead one to believe that no significant changes will be required after FAT and delivery,
in practice a very different picture emerges. Especially during the commissioning phase, changes are commonly made
to the technical systems, especially regarding the control systems. To avoid unnecessary repetition of work it is thusly
indispensable to plan and evaluate the IQ time plan carefully in advance.

Whether the IQ is performed before or after commissioning depends foremost on the type of equipment concerned. For
many types of equipment the IQ has to be executed before commissioning because the commissioning could not be
performed safely otherwise. This includes, for example, mixing equipment or water purification plants with complex
piping. The situation is different for complex packaging machines, for example, or for filling and inspection machines. In
these cases it makes sense to execute the IQ after commissioning because the documentation effort covering all the
required changes and adjustments is too great from a business standpoint. To keep the error rate and the number of
deviations low it is necessary to have a URS and FDS with the appropriate level of detail, yet in contrast the supplier is
obligated to execute the project following quality assurance principles. That in turn demands that a functional quality
assurance system is in place including the instruments to ensure the proper generation, qualification and computer
validation of the control system.

Furthermore, it should be evaluated whether the calibrations should be scheduled as the last test during IQ or the first
test during OQ. The assignment of the calibration either to IQ or OQ is still not clear cut and in the end it depends on the
specific design of the equipment under consideration. While defining and identifying the measuring points versus the
P&ID and checking the calibration certificates can be assigned to the IQ, the execution of the calibration itself often
makes most sense as part of the OQ. This is especially true when the equipment is included in an overarching system
of interacting equipment, which can only be tested during the OQ. In practice calibrations are therefore typically
performed at the end of IQ or at the start of OQ. A watch-out while performing these tests is the duration of the validity
of the calibration certificates (typically one year), which must not be exceeded.

6.E.4 Execution and documentation of the IQ

According to the definition in Annex 15 to the EU GMP Guidelines (compare Figure 6.E-1) one can ascertain which
requirements are placed on the execution of the Installation Qualification (Figure 6.E-3).

Figure 6.E-3 Explanation of the official definition for Installation Qualification

Procedure
The individual steps involved in an IQ and the chronological order within a project are shown in Figure 6.E-4 including
the required information sources.

Figure 6.E-4 Execution of Installation Qualifications

Test items
The essential elements of an IQ are summarized in Figure 6.E-5.

Figure 6.E-5 Typical elements included in an Installation Qualification

Typical elements included in an Installation Qualification

Stocktaking and inventory of the delivered components and checking versus the DQ requirements (URS, FDS,
approved DQ documents); checking the acceptance testing (FAT, SAT)

Check for completeness of the technical documentation required according to the DQ

Inspection of the installation compared to the piping and instrumentation diagram (P&ID) as well as confirmation of the
correct execution and labelling of components

Inspection of the interface connections and the ratings of the energy and utility media supplies

Initial cleaning/passivation of the equipment

Inspection of the installation of measurement and controls components (I/O tests, wiring checks, hardware loop tests,
etc.)

Inspection of the measurement and controls component list (M&C list) as well as the labelling of the quality-relevant
gauges.

Check of all the installed software versions versus the DQ

Check the backup versions versus the DQ and compared to the installed software versions

Hardware configuration check

GMP critical settings based on risk assessment

Verification of screen shots from the HMI versus specification

Verification of access level concepts, audit trail settings, password configuration, etc.

CE conformity or manufacturer's declaration

Generation of standard procedures for calibration and maintenance of the equipment

Generation of standard procedures for cleaning or disinfection/sterilization of the equipment

Maintenance of a list of all deviations occurring during the IQ including responsibility and due date for remediation of
these deviations
Change management
Changes made during the qualification phases are not subject to the pharmaceutical Quality Assurance change control
procedures. These take effect only after the “qualified” status has been obtained. There is often, however, a project-
specific change control procedure in place to make the changes traceable.
After execution of the IQ, a system is to be implemented to control changes, since from this point forward changes to
the system have an impact on the qualification status. Furthermore, agreements between customer and supplier are to
be made when the pharmaceutical change control procedure begins to take effect and how this is covered in the project
scheme.
Documentation
The following content of an Installation Qualification are to be documented appropriately:
● Plan for the execution of the IQ (IQ Plan)
● Test protocols for each of the planned tests (IQ Protocols)
● Report covering the execution of the IQ (IQ Report)
● Checked technical documentation
(as-built documentation)

In Chapter 6.C.3 Structure of qualification documents the structure of the IQ documents and the requirements placed on
them are presented.

6.E Summary
During an Installation Qualification the equipment is checked that it conforms to the requirements placed in the DQ
requirement specifications and that the installation has been performed correctly. The minimum requirements for
testing are given in Annex 15 of the EU GMP Guidelines.
Special attention within this qualification phase is placed on the technical documentation, the scope of which is to be
precisely defined as part of the Design Qualification. The technical documentation is to be provided by the equipment
supplier and must reflect the as-built status after acceptance testing.
Installation Qualification is performed after delivery in parallel to the installation at the customer’s proscribed site.
Depending on the type of equipment, an FAT (factory acceptance test at supplier site) can be performed, during which
parts of the IQ tests may be executed. The SAT (site acceptance test at customer site) is also typically performed
before the Installation Qualification. The chronological order of the equipment commissioning and its Installation
Qualification is dependent upon the project framework and the type of equipment.
The IQ documentation comprises the plan, protocols and report as well as the technical documentation included. Once
the IQ has been completed and the status of the equipment has been defined, a change control system must be
implemented, since changes from this point onward have an influence on its qualification status. For this purpose,
agreements between customer and suppliers are to be made.