LOGFILE No.

8 / August 2011 Maas & Peither AG GMP Publishing

How to Document The design qualification encompasses the

documentation of the planning phase in-
Design Qualification cluding the decision as to which facility will
be used. The DQ should define the re-
quirements for the intended facility.

"The documented verification that the pro-

Author: posed design of the facilities, systems and
Thomas Peither equipment is suitable for the intended pur-
Maas & Peither AG
Halfmann Goetsch Peither AG pose." (EU-GMP Guideline, Annex 15) [2]

Design qualification is the documentation

The qualification of facilities and equip-
ment is part of a life cycle.
of the planning phase, including the deci-
sion making for the equipment. Design
qualification takes place before the equip-
ment is constructed. The risk analysis is
often part of the design qualification. The
earlier risks can be recorded and evalu-
ated, the sooner their minimization can be
taken into consideration in the equipment
or facility construction phase. [3]

With the design qualification, the confor-

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 demon-
strated and documented.
mity 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 sim-
plify and for a clearer arrangement of the

Figure 2 : Example of a trace matrix [4]

UR Spec. Test
UR text TR no. TR text Specification Comments
no. no. number
UR Use of rust- TA 1.1.1 1.4571 or higher SP 1.1 1.4435 IQ 1.1 Material is high
1.1 free stainless is to be used. quality and is there-
steel fore accepted.
TA 1.1.2 The material SP 1.2 3.1B Attestation IQ 1.1 -
must be verified.
SP 1.3 Material confusion IQ 1.1 to be carried out
test with documentation
UR Smooth sur- TA 1.2.1 Roughness SP 1.4 Hand cut with IQ 1.2 -
1.2 face depthRa < 0.8 grain 400
m
SP 1.5 Surface rough- IQ 1.2 Record and number
ness measure- of test points is to
ments with record be defined.

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LOGFILE No. 8 / August 2011
comparison between the user require-
ments and the technical specifications.
The traceability characteristic means con-
sistent referencing between user require-
ments, specifications and test cases. This
makes it possible to trace cross-
references between the specified ele-
ments (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 specifica-
tion) there must in turn be at least one
specification. The project manager can
use the trace matrix in the design qualifi-
cation to show clearly that all user re-
quirements have been taken into account.
In addition, he can use it to check if the
technical specifications are complete and
if the technical implementation corre-
sponds to the requirements. As a last step,
the trace matrix can be used in the test
plan compilation to prove that all user re-
quirements 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 de-
scribe what, why and for what reason.
The configuration of the facility or equip-
ment must reflect the current state-of-the-
art. Therefore, all technical, legal require-
ments (GMP, equipment safety, and em-
ployee protection) must be described and
taken into account in the user specifica-
tions. The information in the user specifi-
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Maas & Peither AG GMP Publishing
cations can be used as a basis for ten-
ders, 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 specifica-
tions are important documents for the le-
gally 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 re-
duce the effort for test performing. It must
be a commitment between pharmaceutical
manufacturer and supplier to get a com-
mon understanding and risk rating to con-
centrate 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 ob-
serve and implement the customer's re-
quirements. The conformity of the user
specifications and the technical specifica-
tions is checked during design qualifica-
tion. To improve the efficiency of a DQ
process it is recommended to implement a
risk analysis to identify critical functions
and features.
Page 2
LOGFILE No. 8 / August 2011 Maas & Peither AG GMP Publishing

Figure 3: Components of user specifications [4]

Project description Brief description of the project and the project objective
Legal requirements GMP rules
Technical facility safety
Safety at work
Environmental protection
Requirements for facility or equipment Construction plans
documentation 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
Environmental conditions at the Permissible floor load
planned place of installation Available utilities and their layout
Potential influencing factors (e.g. dust, vibrations)
Clean room requirements
Room conditions (temperature, air humidity including regula-
tion areas) and finishes
Safety devices Electrical and mechanical locks
Electrical protection classes
Electrical circuit breakers, safety valves, fault reports, alarms
Pressure reduction, non-return valve
Utilities (e.g. gas, water, compressed Utilities including connection values and required perform-
air, nitrogen, steam) ances
Cleanliness requirements
Technical dimensions and weights Installation dimensions
Weight of the overall installation
Material quality 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)
Constructive requirements 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)
Equipment cleaning Cleaning procedures
Cleaning processes (manual, CIP)
Cleansing agent
Performance data (process conditions) Batch size (maximum, minimum)
in routine operation Maximum and minimum process parameters (e.g. stirring
speed, pressure, temperature, time)
Mechanical and electrical performance requirements
Controls Automatic process control
Requirements for computer validation
Control and documentation (e.g. screen, instruments, plant
data documentation paper/electronic)
Calibration, maintenance Definition of the type and working range/sensitivity of meas-
uring points requiring calibration
Maintenance and calibration plan
Maintenance agreements

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LOGFILE No. 8 / August 2011 Maas & Peither AG GMP Publishing

References
GMP MANUAL
[1] Aide Memoire 07121105, ZLG, Germany,
Good Manufacturing Practice &
2010
Implementation
[2] EU-GMP Guide, Annex 15, in GMP MAN-
UAL; Maas & Peither AG, Germany, 2011 Includes 2 Parts:

[3] Design Qualification; GMP MANUAL; Chap- GMP in Practice: 23 chapters written by
ter 6.D; Maas & Peither AG, Germany, 2011 internationally renowned industry experts.
GMP Regulations: 8 chapters with the
[4] Design Qualification, GMP MANUAL, Chap-
ter 6.A.3; Maas & Peither AG, Schopfheim; most important GMP regulations.
2011 Offered in different versions for your con-
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