Installation qualification ensures that pharmaceutical equipment is correctly installed according to design requirements and manufacturer recommendations. It includes a series of tests documented in a format detailing test descriptions, acceptance criteria, and results to validate the installation. Documentation and certifications are crucial throughout the process to verify compliance and ensure proper operating conditions.

1. What to include in Installation
Qualification
Installation Qualification provides documented evidence
that the process equipment is installed according to the
equipment’s design requirements and manufacturer’s
recommendation. Let’s discuss what to include in an
Installation Qualification.
Installation Qualification is part of equipment validation activity, performed
after the equipment is installed.
It provides documented evidence that the pharmaceutical equipment is
installed according to the equipment’s design requirements and the
manufacturer’s recommendation. Additionally, after installation, the equipment
will operate and perform as per the buyer’s requirements.
These requirements and recommendations are thoroughly discussed during
the design qualification phase.
Installation Qualification Format
There are no strict rules and regulations for designing a format, and mainly
depends on the manufacturer and the buyer’s decision. However, a typical
format consists of a test description, its acceptance criteria, and the actual
result.

2. Tests are written in tabular form, with their corresponding acceptance criteria,
actual value, and result, i.e., Pass or Fail.
When a particular set of tests have been conducted, the person conducting
the IQ signs it, and the quality person approves the test by its signature.
Common Installation Qualification format is mentioned blow
S.No Test Acceptance Criteria Result PASS / FAIL

3. In the above table, below is the explanation of each column
● Test: it is parameter under test during the IQ activity
● Acceptance Criteria: The recommended result of the test, on which the
IQ test is considered satisfactory.
● Result: The actual outcome of the test being conducted
● Pass/ Fail: Whether the test is fail or pass, depending upon the test
outcome
Installation Qualification Checklist
Installation Qualification is a series of tests performed related to equipment
installation. Before conducting Installation Qualification, the manufacturer
prepares the desired IQ tests in an approved format. These tests are then
sent to the buyer for their review and approval. When both manufacturer and
buyer approve the test format, the Installation Qualification protocol becomes
official.
Let’s look at common tests routinely performed in an Installation Qualification
activity.
Design Characteristics

4. It includes tests related to the design attributes of the equipment being
installed. It ensures that all the attached components are installed according
to the agreed characteristics.
Let’s look at some design characteristics tests and their acceptance criteria.
S.No Test Acceptance Criteria Result PASS / FAIL
1 Material of construction of
associated components
Piping
Exhaust
Electrical Conduit
Pneumatic Conduit
Duct
SS / MS / Insulation
MS
SS / MS
SS / MS
SS / MS
2 Area of Installation The area must be free
from dust and particle
3 Ventilation There must be
adequate
arrangements of
ventilation in area
4 Foundation The equipment
foundation must be
solid and rigid

5. 5 Space for person movement Adequate space for
operator and other
personnel movement
must be provided
6 Space for material Adequate space for
placing different
material must be
provided
7 Electrical safety The electrical supply
must be properly
provided with relevant
safety system
8 Compressed Air The compressed air
must be supplied with
adequate pneumatic
components and
safety system
9 Steam Line The steam line must
be proper with
adequate components
and safety system
Utility Requirements
This section verifies that the utilities provided are according to the equipment
requirements, as agreed during the design qualification phase.
Every pharma equipment requires standard utility supplies for its satisfactory
performance. The equipment will not operate according to design
specifications if these are not provided.
Some tests common in this section are mentioned below.

6. S.No Test Acceptance Criteria Result PASS / FAIL
1 Electricity The electrical supply must
· 380V/220 VAC
· 3 phase / single phase
2 Steam The steam pressure must be
_____ bar / psi
3 Compressed Air The compressed air must be
___bar / psi.
The compressed air must be
dry, free from water.
4 Natural gas The natural gas pressure must
be-------- bar / psi.
5 Chilled Water The chilled water supply must
be -------- bar / psi, at --------⁰C
6 Purified Water The purified water supply must
be -------- bar / psi.
7 Water for Injection The water for injection supply
must be -------- bar / psi.

8. Documentation
During the design qualification phase, the buyer mentions the documentation
they require, which becomes mandatory for the manufacturer to supply with
equipment.
In this test, the buyer checks and verifies all the required documentation that
the manufacturer has supplied with the equipment.
Some common tests performed in this section include the following.
S.N
o
Test Acceptance Criteria Result PASS / FAIL
1 Operation Manual Operational manual with detailed
guidelines should be supplied
2 Wiring Diagram Wiring diagram with detailed guidelines
should be supplied
3 Maintenance
manual
Maintenance manual, containing
schedule with detailed guidelines should
be supplied

9. 4 Validation
documents
(including DQ, IQ,
OQ and PQ)
Manufacturer must provide complete
Validation documents
5 Preventive
Maintenance
Manual
Manufacturer must provide Preventive
maintenance procedure with complete
6 Calibration Manufacturer must provide calibration
procedure of all measuring instrument
and devices with proper schedule.
7 Spare parts list Manufacturer must provide spare parts
list of all the critical items and
components.
Certificates
This test includes verification that the desired certificates are provided with the
machine, agreed upon during the design qualification stage.
Certificates are necessary because the pharma process are critical and
requires specialized materials, devices, and instruments. To ensure that the

10. manufacturer has adequately applied all requirements, the manufacturer
provides certificates as a proof. Additionally, regulatory authorities such as
the United States FDA can also review them during their routine inspection.
Some common tests performed in this section include the following
S.No Test Acceptance Criteria Result PASS / FAIL
1 Calibration certificates Calibration certificates for all
the recording and measuring
devices must be provided
The certificates must not be
expired
2 Material of
construction
Product contact parts
Non – Product contact
parts
Certificates for material of
construction of specific
machine parts must be
SS 316L
SS 304
Environmental Conditions
In this section, environmental condition equipment is checked and verified.

11. Pharmaceutical equipment require specific conditions for their satisfactory
performance. If the desired environmental conditions are not provided, it will
negatively impact the output product and equipment performance.
Some common tests performed in this section include the following.
S.No Test Acceptance Criteria Result PASS / FAIL
1 Area Temperature The temperature must be-----
⁰C
2 Area Humidity The humidity must be --------
4 Laminar Flow Laminar air flow with ----- air
speed must be installed
5 Air Changes Air changes in the area must
be ----
6 Differential Pressure Differential pressure of the
area must be-------
The pressure in the areas
must be negative / positive
Area Classification The area for production must
be ___ (Class A , B , C , D)