6.

E Installation qualification (IQ)

6.E Installation qualification (IQ)

Here you will find answers to the following questions:

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• What is understood by the term "IQ"?
• When is FAT and/or SAT necessary?
• What is the scope of the technical documentation?
• What documents are reviewed during IQ?

Definition of IQ (EU GMP Guideline, 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."

Figure 6.E-1 Definition of IQ

6.E
Installation qualification is the documented evidence that the equipment com-
plies with the requirements made of it in terms of identity, installation, conformity
with the guidelines and documentation. Installation qualification takes place after
delivery of the equipment, at the same time as installation/assembly of the equip-
ment at the place of installation. In the case of preassembled equipment, the
installation qualification can be carried out, at least partially, at the supplier's
premises (for example: water treatment system).
During installation qualification, the equipment is tested for conformity with
the user requirements and for proper installation. During installation qualification,
the overall scope of delivery of the equipment is identified and confirmation is
given that all components of the delivery correspond to the specifications defined
in the technical specification during the planning phase. The essential elements of
installation qualification are summarised in figure 6.E-2.
In this qualification phase, particular attention is placed on the technical docu-
mentation, the scope of which is to be described precisely during design qualifica-
tion and which is to be provided by the supplier (see chapter 6.D Design qualifica-
tion (DQ) and chapter 4.F Technical documentation). To ensure a good customer-
supplier relationship, it is recommended that the exact time of provision of the
technical documentation be defined. It is not always advisable to deliver this at the
same time as the equipment, as foreseeable (planned) adaptations also involve
changes to the documentation. Figure 6.E-3 shows an overview of the scope of
the technical documentation.
Acceptance at the supplier's premises (Factory Acceptance Test, FAT ) is
optional. Acceptance after delivery of the pharmaceutical process equipment (Site
Acceptance Test, SAT ) is legally required and includes all characteristics approved
in the user specifications and specified in the technical specifications and order.

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 6 Qualification

Typical elements of installation qualification

• Stocktaking and inventory of the delivered components and checking against DQ

requirements; Final acceptance check (FAT, SAT)
• Check for completeness of the technical documentation required in the DQ

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• Checking assembly based on the pipework and instrumentation plans (R&I plans)
and confirmation of correct execution
• Checking of the EMR installation (I/O tests, wiring checks, hardware loop tests)
• Compilation of a measuring and control technology point list (MSR list) and defini-
tion of the quality-related measuring points
• Checking the connections and connection parameters of the energy and utilities
supply
• Initial cleaning/passivation of the equipment
• Identification of software and hardware components
• Compilation of an operating procedure for calibration and maintenance of the
equipment
• Compilation of an operating procedure for cleaning or disinfection/sterilisation of
the equipment
• Compilation of a list of all deviations that occurred during the IQ, with specification
6.E

of the responsible person and deadlines for removal of these deviations

Figure 6.E-2 Typical elements of installation qualification

Possible scope of the supplier's technical documentation

• Technical specifications • Specifications/certificates for lubri-

• Description of the equipment
• Operating manual
• Operating instructions
• Functional diagram
• Assembly/layout plans
• P & I plans
• Channelling plans
• Energy and utilities supply (includ-
ing operational parameters)
• Technical data sheets
cants, processing aids and utilities
• Material certificates of product contact
parts
• Environmental conditions
• Alarm concept
• Maintenance procedure (including in-
tervals in operating hours)
• Cleaning procedure
• Terminal plans
• Calibration procedure and calibration
report for works calibration

Figure 6.E-3 Possible scope of the supplier's technical documentation

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 6.E Installation qualification (IQ)

After acceptance of the equipment, the technical documentation must corre-

spond to the ACTUAL status (as built). In the documentation, the manufacturer
must take into account all changes made during the construction, assembly and
start-up phases. Changes during the qualification phase are not subject to the
change control procedure of pharmaceutical quality assurance. This begins after

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the "qualified" status has been assigned (often there is a project-specific change
control procedure).

6.E.1 Examples of IQ plans

The general requirements of the qualification documentation are described in

chapter 6.C Qualification documentation, including examples of test plans, see fig-
ure 6.C-4 and figure 6.C-5. There are numerous ways of structuring the individual
documents. One possible systematic procedure is presented in this chapter. The
forms may be used as a template for filling with the facility-specific test points. The
documents are structured so that the qualification plan (list of the test points with
acceptance criteria) and the test protocol (documentation of the test carried out)

6.E
are summarised in a single document.

The following forms are included:

• IQ test protocol: Materials and lubricants page 4
• IQ test protocol: Utilities (energy and media) supply page 7
• IQ test protocol: M&C points and initial calibration page 9
• IQ test protocol: Calibration records page 11
• IQ test protocol: P&I diagrams page 13
• IQ test protocol: Pipelines page 16
• IQ test protocol: Technical documentation page 18
• IQ qualification report page 21

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 6 Qualification

6.E.1.1 Materials and lubricants

Company IQ qualification plan Page x v. y

IQ test protocol 1
Materials and lubricants

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QP-0815-4711 Qualification plan for facilities and equipment valid from
for pharmaceutical products at the Ixberg site 01.10.2005

Qualification Facility/equipment Inventory no.

project no.

Record compiled
(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

(Date/signature)
6.E

Test result approved

(Date/signature)

1. Scope
This test protocol is an integral part of the qualification plan in accordance with qualifica-
tion master plan 0915 and is valid at the Ixberg site for the qualification of new and exist-
ing manufacturing and control equipment for pharmaceutical products. It does not re-
late to the qualification of computer systems. This document must also be used if the
qualification (or parts thereof ) is to be carried out by external companies or consultants.

2. Test item
Subject of the test is all energy and utilities connections of the facility to be qualified.

3. Performance of test
Using the manufacturer's documentation (e.g. certificates), it must be checked if all prod-
uct contact materials, lubricants and other quality relevant materials meet the require-
ments of the DQ. The materials actually used, including the surface properties (e.g.
roughness, or inertisation) are to be entered in the test list.

Figure 6.E-4 IQ test protocol 1: Materials and lubricants

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 6.E Installation qualification (IQ)

Company IQ qualification plan Page x v. y

IQ test protocol 1
Materials and lubricants
QP-0815-4711 Qualification plan for facilities and equipment valid from

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for pharmaceutical products at the Ixberg site 01.10.2005

Qualification Facility/equipment Inventory no.

project no.

4. Test list

Actual value (e.g.

Acceptance criterion (in
Test feature in accordance Date Signature
accordance with § DQ)
with certificate)

Product contact parts

4.1

6.E
4.2

4.3

4.4

4.5

Lubricant

4.8

4.9

4.10

4.11

Other quality relevant materials

4.13

4.14

4.15

4.16

Figure 6.E-4 IQ test protocol 1: Materials and lubricants (cont.)

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 6 Qualification

Company IQ qualification plan Page x v. y

IQ test protocol 1
Materials and lubricants
QP-0815-4711 Qualification plan for facilities and equipment valid from

EXCERPT of GMP MANUAL - www.gmp-manual.com

for pharmaceutical products at the Ixberg site 01.10.2005

Qualification Facility/equipment Inventory no.

project no.

5. Test result

❍ Accepted

❍ Not accepted, due to Measures required

Figure 6.E-4 IQ test protocol 1: Materials and lubricants (cont.)

6.E

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 6.E Installation qualification (IQ)

6.E.1.2 Supply of (energy and media) utilities

Company IQ qualification plan Page x v. y

IQ test protocol 2
Utilities (energy and media) supply

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QP-0815-4712 Qualification plan for facilities and equip- valid from
ment for pharmaceutical products at the 01.10.2005
Ixberg site

Qualification Facility/equipment Inventory no.

project no.

Record compiled
(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

6.E
(Date/signature)

Test result approved

(Date/signature)

1. Scope
This test protocol is an integral part of the qualification plan in accordance with quali-
fication master plan 0915 and is valid at the Ixberg site for the qualification of new and
existing manufacturing and control equipment for pharmaceutical products. It does
not relate to the qualification of computer systems.
This document must also be used if the qualification (or parts thereof ) is to be carried
out by external companies or consultants.

2. Test item
Subject of the test is all utilities connections of the facility to be qualified.

3. Performance of test
All utilities connections available on the equipment are
• identified and labelled (in accordance with SOP 03567),
• compared with the DQ specifications
• compared with the manufacturer's documentation
• professionally connected to the corresponding house connections.

Figure 6.E-5 IQ test protocol 2: Utilities (energy and media) supply

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 6 Qualification

Company IQ qualification plan Page x v. y

IQ test protocol 2
Utilities (energy and media) supply
QP-0815-4712 Qualification plan for facilities and equip- valid from

EXCERPT of GMP MANUAL - www.gmp-manual.com

ment for pharmaceutical products at the 01.10.2005
Ixberg site

Qualification Facility/equipment Inventory no.

project no.

4. Test list
(in accordance

Actual value
Test feature

Acceptance

Connected
with § DQ)

Signature
Labelling
criterion

Date
6.E

Energy form

4.1

4.2

4.3

4.4

4.5

4.6

Medium (gas, water, steam, etc)

4.8

4.9

4.10

4.11

4.12

5. Test result

❍ Accepted

❍ Not accepted, due to Measures required

Figure 6.E-5 IQ test protocol 2: Utilities (energy and media) supply (cont.)

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 6.E Installation qualification (IQ)

6.E.1.3 Measuring and control technology points and initial calibration

Company IQ qualification plan Page x v. y

IQ test protocol 3:
M&C (Measuring and control) points

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and initial calibration
QP-0815-4713 Qualification plan for facilities and equipment valid from
for pharmaceutical products at the Ixberg site 01.10.2005

Qualification Facility/equipment Inventory no.

project no.

Record compiled
(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

6.E
(Date/signature)

Test result approved

(Date/signature)

1. Scope
This test protocol is an integral part of the qualification plan in accordance with qualifi-
cation master plan 0915 and is valid at the Ixberg site for the qualification of new and
existing manufacturing and control equipment for pharmaceutical products. It does
not relate to the qualification of computer systems. This document must also be used if
the qualification (or parts thereof ) is to be carried out by external companies or consult-
ants.

2. Test item
Subject of the test is all measuring and control points of the facility to be qualified.

3. Performance of test
All M&C points available on the equipment are
• identified and labelled (in accordance with SOP 03568),
• compared with the DQ specifications
• compared with the manufacturer's documentation
• assessed as to whether calibration is required,
• initial calibration is carried out in accordance with SOP 98765.

Figure 6.E-6 IQ test protocol 3: Measuring and control technology points and
initial calibration

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 6 Qualification

Company IQ qualification plan Page x v. y

IQ test protocol 3:
M&C (Measuring and control) points
and initial calibration

EXCERPT of GMP MANUAL - www.gmp-manual.com

QP-0815-4713 Qualification plan for facilities and equipment valid from
for pharmaceutical products at the Ixberg site 01.10.2005

Qualification Facility/equipment Inventory no.

project no.

4. Test list
(in accordance with § DQ)
Acceptance criterion

Require calibration

Initial calibration
Actual value
Test feature

Signature
Labelling
6.E

Date

M&C point

4.1

4.2

4.3

4.4

4.5

4.6

5. Test result

❍ Accepted

❍ Not accepted, due to Measures required

Figure 6.E-6 IQ test protocol 3: Measuring and control technology points and
initial calibration (cont.)

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