Escolar Documentos
Profissional Documentos
Cultura Documentos
8 / August 2011
How to Document
Design Qualification
Author:
Thomas Peither
Maas & Peither AG
Halfmann Goetsch Peither AG
Trace Matrix
A simple trace matrix can be used to simplify and for a clearer arrangement of the
UR
no.
UR
1.1
UR
1.2
UR text
TR no.
TR text
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
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
-
http://www.gmp-publising.com/
2011 Maas & Peither AG GMP Publishing, Germany, all rights reserved
Page 1
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-
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.
http://www.gmp-publising.com/
2011 Maas & Peither AG GMP Publishing, Germany, all rights reserved
Page 2
Safety devices
Constructive requirements
Equipment cleaning
Performance data (process conditions)
in routine operation
Controls
Calibration, maintenance
http://www.gmp-publising.com/
2011 Maas & Peither AG GMP Publishing, Germany, all rights reserved
Page 3
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
[4] Design Qualification, GMP MANUAL, Chapter 6.A.3; Maas & Peither AG, Schopfheim;
2011
Author:
Thomas Peither
Maas & Peither AG
Halfmann Goetsch Peither AG
CD-ROM only
thomas.peither@gmp-publishing.com
thomas.peither@hgp.ag
Phone +49 7622 666 86-70
Karlstrasse 2
79650 Schopfheim
Deutschland
More information:
http://www.gmp-publishing.com
For a free online-trial contact:
annette.crawford@gmp-publishing.com
http://www.gmp-publising.com/
2011 Maas & Peither AG GMP Publishing, Germany, all rights reserved
Page 4