Protocol DQ 07/21-001

Design Qualification (DQ) Page 1 of 6

Rev.: 1
Romaco Kilian S 710 Prime Date: 18 Jul 2021
Attachment No.: 004

Aim of the Design Qualification

The aim of the present DQ Protocol is to provide the documented proof that for the newly planned/
system Romaco Kilian S 710 Prime:
 all quality relevant requirements (GMP) are listed as specifications in a User Requirement Specifications
document (URS).
 the specifications from the URS are correctly transferred to the technical documentation/scope
statement of the manufacturer/provider/distributor.
 all quality relevant changes during the planning stage are considered in the relevant executive
documents

Document history

Rev. Date Reason for Change Name /Company, Department

1 18 Jun 2021 Production increase Tim-Andreas Moll/HHU, Production

Author – Authorization - Release

Department/
Name Function Date Signature

Author Tim-Andreas Moll Production, Manager 18 Jun 2021 Tim-A. Moll

Production, Head of
Authorization Department
Quality Control, Head of
Authorization Department
Engineering, Head of
Authorization Department
Quality Assurance, Head
Release of Department
 Protocol DQ 07/21-001
Design Qualification (DQ) Page 2 of 6

Rev.: 1
Romaco Kilian S 710 Prime Date: 18 Jul 2021
Attachment No.: 004

1 Related Documents

Document Document No.

Risk-Trace-Matrix 1
Validation Master Plan 2
User Requirement Specifications 3
Operation Manuals 4
Installation Manual 5
Guarantee Card 6
Technical Drawings 7
Service part list 8
Maintenance Manual 9
Cleaning Manual 10
Performance Qualification 11
Factory Acceptance Test 12
Site Acceptance Test 13

2 Design Qualification

2.1 Scope of the Design Qualification

The following tests are to be performed for the system Romaco Kilian S 710 Prime:

Cons. No. Subject of the test: Acceptance criteria

1
GMP – classification has been
performed;
Test for the systematic registration and written documentation
2.1.1 Risk analysis based on the GMP
of all GMP relevant requirements
classification are available; All
requirements have been listed in the
URS.
All requirements specified in the URS
Test for compliance of technical documents of the can be found correctly in the technical
2.1.2 manufacturer/distributor with the specifications listed documentation of the
in the URS manufacturer/distributor

GMP – relevant changes have

been documented by Change
Test for correct documentation of GMP-relevant changes Control Management and can be
2.1.3
found in the technical
documentation

1
The GMP classification defines the policies relevant for the present case
 Protocol DQ 07/21-001
Design Qualification (DQ) Page 3 of 6

Rev.: 1
Romaco Kilian S 710 Prime Date:
Attachment No.:
18 Jul 2021
004

2.1.1 Test for the systematic registration and written documentation of all GMP relevant
requirements

The quality relevant requirements of the system Romaco Kilian S 710 Prime are
analyzed and specified in the following document:

Anforderungen:
GMP-classification has been performed; Risk
analysis based on the GMP classification is
present; All requirements are listed in the URS.
Document File location
Present Complete Up-to-date
yes no yes no yes no

Risk analysis Folder: X:\Production\Upgrade\HSTP X X X

Validation Master Plan Folder: X:\Production\Upgrade\HSTP X X X

URS Folder: X:\Production\Upgrade\HSTP X X X

Please mark with a cross where applicable!

Comments:

Yes No
Results: The requirements are fulfilled: x

Performed by: Date Signature

Tim-Andreas Moll 18 Jun 2021 Tim-A. Moll
Checked for accuracy by: Date Signature
 Protocol DQ 07/21-001
Design Qualification (DQ) Page 4 of 6

Rev.: 1
Romaco Kilian S 710 Prime Date:
Attachment No.:
18 Jul 2021
004

2.1.2 Test for compliance of technical documents of the manufacturer/distributor with

the specifications listed in the URS

The following technical documents for the system Romaco Kilian S 710 Prime have been
checked for accordance with the requirements specified in the URS:

Requirements:
All requirements specified in the
URS can be found correctly in the
technical documentation of the
Document Description of the requirement manufacturer/distributor.2

fulfilled:
yes no
Operation Manuals Settings of the machine X

Installation Manual Setup of the machine, technical data x

Maintenance Manual Machine maintenance instruction X

Cleaning Manual CIP/SIP instructions X

Site Acceptance Test Delivery protocol and appropriate documents X

Please mark with a cross where applicable!

Comments:

Yes No
Results: The requirements are fulfilled: X
Performed by: Date Signature
Tim-Andreas Moll 18 Jun 2021 Tim-A. Moll
Checked for accuracy by: Date Signature

2
The relevant technical documets are to be listed under “related documents”
 Protocol DQ 07/21-001
Design Qualification (DQ) Page 5 of 6

Rev.: 1
Romaco Kilian S 710 Prime Date:
Attachment No.:
18 Jul 2021
004

2.1.3 Test for correct documentation of GMP-relevant changes

The following relevant changes to the URS regarding System Romaco Kilian S 710
Prime have been made, documented, and transferred to the technical
documentation during the planning phase.

Requirements:
GMP – relevant changes have been
documented by Change Control
Management (SOP- XX-XXX) and can be
Description of relevant changes: found in the technical documentation

Fulfilled:
yes no
none x

Please mark with a cross where applicable!

Comments:

Yes No
Results: The requirements are fulfilled: X

Performed by: Date Signature

Tim-Andreas Moll 18 Jun 2021 Tim-A. Moll
Checked for accuracy by: Date Signature
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Design Qualification (DQ) Page 6 of 6

Rev.: 1
Romaco Kilian S 710 Prime Date: 18 Jul 2021
Attachment No.: 004

3 Completion of DQ and release for start of IQ

The DQ has been performed successfully without constraints

X

The DQ has been performed successfully with constraints. The

Constraints are not quality relevant and have no impact on the further
qualification (see constraint assessment)

The DQ was not successful.

The identified constraints are quality relevant and have an impact on the
further qualification.

Rectification of the constraints was: sufficient 3 requalification is necessary 4

Comments:

Release for starting the IQ X no release

Executer Date Signature

Tim-Andreas Moll 18 Jun 2021 Tim-A. Moll
Validation commissioner Date Signature

Release by head of department Date Signature

3
The successful rectification of all constrains has to be documented under „Comments“. Afterwards, release can be executed.

4
In case of requalification, the scope and extend of such has to be documented under “Comments” and if necessary in a
separate document. Release and IQ is not possible in this case. In has to be performed based on the requalification.