LOGFILE No.

8 / August 2011

Maas & Peither AG GMP Publishing

How to Document
Design Qualification

The design qualification encompasses the

documentation of the planning phase including the decision as to which facility will
be used. The DQ should define the requirements for the intended facility.
"The documented verification that the proposed design of the facilities, systems and
equipment is suitable for the intended purpose." (EU-GMP Guideline, Annex 15) [2]

Author:
Thomas Peither
Maas & Peither AG
Halfmann Goetsch Peither AG

The qualification of facilities and equipment is part of a life cycle.

Figure 1: Life cycle approach [1]

The first stage of a qualification should be

the design qualification (DQ). According to
Annex 15, conformance of the design with
the GMP requirements should be demonstrated and documented.

Design qualification is the documentation

of the planning phase, including the decision making for the equipment. Design
qualification takes place before the equipment is constructed. The risk analysis is
often part of the design qualification. The
earlier risks can be recorded and evaluated, the sooner their minimization can be
taken into consideration in the equipment
or facility construction phase. [3]
With the design qualification, the conformity of the equipment or facility planning
with certain requirements is reviewed. To
this end, the requirements laid out in the
user requirements are compared with the
specifications compiled by the supplier
(technical specifications) and confirmed in
writing. [3]

Trace Matrix
A simple trace matrix can be used to simplify and for a clearer arrangement of the

Figure 2 : Example of a trace matrix [4]

UR
no.
UR
1.1

UR
1.2

UR text

TR no.

TR text

Use of rustfree stainless

steel

TA 1.1.1

1.4571 or higher
is to be used.

TA 1.1.2

The material
must be verified.

Smooth surface

TA 1.2.1

Roughness
depthRa < 0.8
m

Spec.
no.
SP 1.1

1.4435

Test
number
IQ 1.1

SP 1.2

3.1B Attestation

IQ 1.1

SP 1.3

Material confusion
test
Hand cut with
grain 400

IQ 1.1

Surface roughness measurements with record

IQ 1.2

SP 1.4

SP 1.5

Specification

IQ 1.2

Comments
Material is high
quality and is therefore accepted.
to be carried out
with documentation
-

Record and number

of test points is to
be defined.

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LOGFILE No. 8 / August 2011

comparison between the user requirements and the technical specifications.

The traceability characteristic means consistent referencing between user requirements, specifications and test cases. This
makes it possible to trace crossreferences between the specified elements (traceability). To this end, the user
requirements are to be provided with
unique numbers, so that referencing is
possible. Figure 2 shows a possible trace
matrix
For each user requirement (UR), there
must be at least one technical requirement
(TR). This is a 1:n relationship. For each
technical requirement (technical specification) there must in turn be at least one
specification. The project manager can
use the trace matrix in the design qualification to show clearly that all user requirements have been taken into account.
In addition, he can use it to check if the
technical specifications are complete and
if the technical implementation corresponds to the requirements. As a last step,
the trace matrix can be used in the test
plan compilation to prove that all user requirements have been tested.

User Requirements
The purpose of the user specifications is
to define the user's pharmaceutical and
technical requirements for the facility or
equipment (= user requirements). This
ensures that the facility or equipment is
suitable for the later application and that
the facility or equipment can be used to
manufacture a product that is in line with
the specifications under GMP-conform
conditions. The user specifications describe what, why and for what reason.
The configuration of the facility or equipment must reflect the current state-of-theart. Therefore, all technical, legal requirements (GMP, equipment safety, and employee protection) must be described and
taken into account in the user specifications. The information in the user specifi-

Maas & Peither AG GMP Publishing

cations can be used as a basis for tenders, offers and/or contracts.

Figure 3 shows the typical contents of user
specifications.

Technical Specifications
The technical specifications represent the
transformation of the requirements laid out
in the user specifications into the binding
technical specifications and requirements
for the supplier (technical requirements).
In certain cases, a detailed proposal can
replace the technical specifications (e.g. in
the procurement of HPLC facilities as
equipment off the shelf).
User requirements and technical specifications are important documents for the legally prescribed acceptance after delivery
of the equipment.

Risk Analysis
A lot of companies perform risk analysis to
identify the critical functions of a technical
system. This is an important step to reduce the effort for test performing. It must
be a commitment between pharmaceutical
manufacturer and supplier to get a common understanding and risk rating to concentrate on the real risks of a technical
system. In the past, nearly every function
or feature were tested. If you follow a risk
based approach it has to make differences
between critical and uncritical functions
and features. And there can be again a
reference to the trace matrix.

Summary
To avoid surprises, the equipment must be
carefully planned and exactly specified.
The supplier undertakes to accurately observe and implement the customer's requirements. The conformity of the user
specifications and the technical specifications is checked during design qualification. To improve the efficiency of a DQ
process it is recommended to implement a
risk analysis to identify critical functions
and features.

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LOGFILE No. 8 / August 2011

Maas & Peither AG GMP Publishing

Figure 3: Components of user specifications [4]

Project description
Legal requirements

Requirements for facility or equipment

documentation

Environmental conditions at the

planned place of installation

Safety devices

Utilities (e.g. gas, water, compressed

air, nitrogen, steam)
Technical dimensions and weights
Material quality

Constructive requirements

Equipment cleaning
Performance data (process conditions)
in routine operation

Controls

Calibration, maintenance

Brief description of the project and the project objective

GMP rules
Technical facility safety
Safety at work
Environmental protection
Construction plans
Diagrams (e.g. R & I, measuring and control technology,
electrics, hydraulics/pneumatics, utilities, plumbing, assembly
plan)
Usage procedures
Maintenance procedures
Spare parts list
Conformity declarations
Permissible floor load
Available utilities and their layout
Potential influencing factors (e.g. dust, vibrations)
Clean room requirements
Room conditions (temperature, air humidity including regulation areas) and finishes
Electrical and mechanical locks
Electrical protection classes
Electrical circuit breakers, safety valves, fault reports, alarms
Pressure reduction, non-return valve
Utilities including connection values and required performances
Cleanliness requirements
Installation dimensions
Weight of the overall installation
Compatibility certificates for product contact surfaces
Certificates for purchased components (e.g. software)
Requirements for the surface properties (e.g. roughness)
Required surface passivation (inertization)
Utilities supply and filter classes
Control equipment and systems for plant data acquisition
Sampling devices
Extension possibilities (e.g. additional docking points and
additional interfaces)
Cleaning procedures
Cleaning processes (manual, CIP)
Cleansing agent
Batch size (maximum, minimum)
Maximum and minimum process parameters (e.g. stirring
speed, pressure, temperature, time)
Mechanical and electrical performance requirements
Automatic process control
Requirements for computer validation
Control and documentation (e.g. screen, instruments, plant
data documentation paper/electronic)
Definition of the type and working range/sensitivity of measuring points requiring calibration
Maintenance and calibration plan
Maintenance agreements

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LOGFILE No. 8 / August 2011

Maas & Peither AG GMP Publishing

References
[1] Aide Memoire 07121105, ZLG, Germany,
2010

GMP MANUAL
Good Manufacturing Practice &
Implementation

[2] EU-GMP Guide, Annex 15, in GMP MANUAL; Maas & Peither AG, Germany, 2011

Includes 2 Parts:

[3] Design Qualification; GMP MANUAL; Chapter 6.D; Maas & Peither AG, Germany, 2011

GMP in Practice: 23 chapters written by

internationally renowned industry experts.

[4] Design Qualification, GMP MANUAL, Chapter 6.A.3; Maas & Peither AG, Schopfheim;
2011
Author:

GMP Regulations: 8 chapters with the

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Maas & Peither AG
Halfmann Goetsch Peither AG

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