Here you will find answers to the following questions:

• What is understood by the term "IQ"?
• When is FAT and/or SAT necessary?
• What is the scope of the technical documentation?
• What documents are reviewed during IQ?

Installation qualification (IQ)

"The documented verification that the facilities, systems and equipment, as installed ormodified, comply with the approved design and the manufacturer's recommendations."

• Stocktaking and inventory of the delivered components and checking against DQ requirements; Final acceptance check (FAT, SAT)
• Check for completeness of the technical documentation required in the DQ
• Checking assembly based on the pipework and instrumentation plans (R & I plans) and confirmation of correct execution
• Checking of the EMR installation (I/O tests, wiring checks, hardware loop tests)
• Compilation of a measuring and control technology point list (MSR list) and definition of the quality-related measuring points
• Checking the connections and connection parameters of the energy and utilities supply
• Initial cleaning/passivation of the equipment
• Identification of software and hardware components
• Compilation of an operating procedure for calibration and maintenance of the equipment
• Compilation of an operating procedure for cleaning or disinfection/sterilisation of the equipment
• Compilation of a list of all deviations that occurred during the IQ, with specification of the responsible person and deadlines for removal of these deviations

• Technical specifications
• Description of the equipment
• Operating manual
• Operating instructions
• Functional diagram
• Assembly/layout plans
• P & I plans
• Channelling plans
• Energy and utilities supply (including operational parameters)
• Technical data sheets

• Specifications/certificates for lubricants, processing aids and utilities
• Material certificates of product contact parts
• Environmental conditions
• Alarm concept
• Maintenance procedure (including intervals in operating hours)
• Cleaning procedure
• Terminal plans
• Calibration procedure and calibration report for works calibration

Record compiled

(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

(Date/signature)

Test result approved

(Date/signature)

1. Scope

This test protocol is an integral part of the qualification plan in accordance with qualification master plan 0915 and is valid at the Ixberg site for the qualification of new and existing manufacturing and control equipment for pharmaceutical products. It does not relate to the qualification of computer systems. This document must also be used if the qualification (or parts thereof) is to be carried out by external companies or consultants.

2. Test item

Subject of the test is all energy and utilities connections of the facility to be qualified.

3. Performance of test

Using the manufacturer's documentation (e.g. certificates), it must be checked if all product contact materials, lubricants and other quality relevant materials meet the requirements of the DQ. The materials actually used, including the surface properties (e.g. roughness, or inertisation) are to be entered in the test list.

4. Test list

Test feature

Acceptance criterion (in accordance with § DQ)

Actual value (e.g. in accordance
with certificate)

Date

Signature

Product contact parts

4.1

4.2

4.3

4.4

4.5

Lubricant

4.8

4.9

4.10

4.11

Other quality relevant materials

4.13

4.14

4.15

4.16

5. Test result

m Accepted

m  Not accepted, due to

Measures required

Record compiled

(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

(Date/signature)

Test result approved

(Date/signature)

1. Scope

This test protocol is an integral part of the qualification plan in accordance with qualification master plan 0915 and is valid at the Ixberg site for the qualification of new and existing manufacturing and control equipment for pharmaceutical products. It does not relate to the qualification of computer systems.

This document must also be used if the qualification (or parts thereof) is to be carried out by external companies or consultants.

2. Test item

Subject of the test is all utilities connections of the facility to be qualified.

3. Performance of test

All utilities connections available on the equipment are

• identified and labelled (in accordance with SOP 03567),
• compared with the DQ specifications
• compared with the manufacturer's documentation
• professionally connected to the corresponding house connections.

4. Test list

Test feature

Acceptance
criterion
(in accordance
with § DQ)

Actual value

Labelling

Connected

Date

Signature

Energy form

4.1

4.2

4.3

4.4

4.5

4.6

Medium (gas, water, steam, etc)

4.8

4.9

4.10

4.11

4.12

5. Test result

m Accepted

m  Not accepted, due to

Measures required

Record compiled

(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

(Date/signature)

Test result approved

(Date/signature)

1. Scope

This test protocol is an integral part of the qualification plan in accordance with qualification master plan 0915 and is valid at the Ixberg site for the qualification of new and existing manufacturing and control equipment for pharmaceutical products. It does not relate to the qualification of computer systems. This document must also be used if the qualification (or parts thereof) is to be carried out by external companies or consultants.

2. Test item

Subject of the test is all measuring and control points of the facility to be qualified.

3. Performance of test

All M & C points available on the equipment are

• identified and labelled (in accordance with SOP 03568),
• compared with the DQ specifications
• compared with the manufacturer's documentation
• assessed as to whether calibration is required,
• initial calibration is carried out in accordance with SOP 98765.

4. Test list

Test feature

Acceptance criterion
(in accordance with § DQ)

Actual value

Labelling

Require calibration

Initial calibration

Date

Signature

M & C point

4.1

4.2

4.3

4.4

4.5

4.6

5. Test result

m Accepted

m  Not accepted, due to

Measures required

Record compiled

(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

(Date/signature)

Test result approved

(Date/signature)

1. Scope

This test protocol is an integral part of the qualification plan in accordance with qualification master plan 0915 and is valid at the Ixberg site for the qualification of new and existing manufacturing and control equipment for pharmaceutical products. It does not relate to the qualification of computer systems. This document must also be used if the qualification (or parts thereof) is to be carried out by external companies or consultants.

2. Test item

Subject of the test is the calibration records for all measuring points that require calibration in accordance with the list of measuring and control points (test protocol 3).

3. Performance of test

The following is reviewed for all measuring points that require calibration:

• Calibration protocol of the initial calibration available at the specified storage location (in accordance with SOP 03567)
• Traceability of the calibration to a certified standard, if existing
• Calibration in accordance with valid SOP (for the corresponding measuring point)
• Recalibration interval defined
• Measuring point included in the calibration plan.

The acceptance criteria are:

• The calibration records are complete, signed and available at the specified storage location.
• Traceability of the calibration to a certified standard, if existing
• Calibration was carried out in accordance with a valid SOP (for the corresponding measuring point).
• A recalibration interval has been defined and documented.
• The measuring point is included in the calibration plan.

4. Test list

Test feature

Calibration record available

Traceability
to certified standard

Calibration in
accordance with valid SOP

Recalibration interval
defined

Included in calibration list

Date

Signature

M & C point

4.1

4.2

4.3

4.4

4.5

4.6

4.7

4.8

4.9

5. Test result

m Accepted

m  Not accepted, due to

Measures required

Record compiled

(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

(Date/signature)

Test result approved

(Date/signature)

1. Scope

This test protocol is an integral part of the qualification plan in accordance with qualification master plan 0915 and is valid at the Ixberg site for the qualification of new and existing manufacturing and control equipment for pharmaceutical products. It does not relate to the qualification of computer systems. This document must also be used if the qualification (or parts thereof) is to be carried out by external companies or consultants.

2. Test item

Subject of the test is the P & I diagram of the facility to be qualified.

3. Performance of test

1. Correct identification of the P & I diagram: Check if the facility name/number is marked in the drawing header of the P & I diagram.

2. Checking of the P & I diagram and the installation of the facility.
Conformities are marked clearly on the plan as a tick. Deviations must be corrected on the plan. Conformity of the following points must be checked between the plan and the facility and documented in the plan with red markings:

• Correct illustration of the components
• Correct designation of the components on the P & I
• Labelling of the facility conforms to the requirements in the P & I
• Labelling is applied in a clearly legible manner in all places
• Places of installation of the actors and sensors and the allocation of the components conforms to the P & I.

3. Checking the P & I diagram to see if all the components indicated on the P & I are available in the facility and if all the components available in the facility are indicated in the P & I.

4. Check if all pipes are labeled with direction of flow and content. The qualification copy of the P & I diagram is to be enclosed as an appendix to this test protocol.

The acceptance criterion is: Installation and documentation are conform.

4. Test list

Test feature

OK

Not OK

Date

Signature

P&I diagram no..............

4.1 The facility is clearly identifiable in the drawing header.

4.2 The components are illustrated correctly.

4.3 The designations of the components on the P & ID are correct.

4.4 Labelling conforms to the requirements in the P & I diagram.

4.5 The labelling is applied in a clearly legible manner in all places

4. The places of installation of the actors and sensors and the allocation of the components conform to the P & ID.

4.7 All components indicated on the P & ID are available in the facility.

4.8 All components available in the facility are indicated on the P & ID.

4.9 All pipes are labeled with direction of flow and content.

5. Test result

m Accepted

m  Not accepted, due to

Measures required

Record compiled

(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

(Date/signature)

Test result approved

(Date/signature)

1. Scope

This test protocol is an integral part of the qualification plan in accordance with qualification master plan 0915 and is valid at the Ixberg site for the qualification of new and existing manufacturing and control equipment for pharmaceutical products. It does not relate to the qualification of computer systems.
This document must also be used if the qualification (or parts thereof) is to be carried out by external companies or consultants.

2. Test item

Subject of the test is the pipes (including their connections, welds) of the facility to be qualified.

3. Performance of test

1. Visual inspection of the connections, to ensure that they are welded in accordance with the DQ with the TIG welding (tungsten inert gas) procedure or through manual welds and that they are installed without defects.

2. Colour labelling of the connections that have been tested in the weld documentation (to be enclosed as an appendix to this test protocol).

The acceptance criteria are:

1. All pipes are welded. Only in exceptional cases were detachable connections selected.

2. Only the required welding procedure (WIG orbital welding) has been used. Manual welding has only been used where absolutely necessary.

4. Welds are visually (in accordance with EN 970) OK.
Test list

Test feature

Connection type

Welding procedure

Free from defects

Date

Signature

Test point 1

Test point 2

Test point 3

Test point 4

Test point 5

Test point 6

Test point 7

Test point 8

Test point 9

5. Test result

m Accepted

m  Not accepted, due to

Measures required

Record compiled

(Date/signature)

Record approved for implementation

(Date/signature)

Test carried out

(Date/signature)

Test result approved

(Date/signature)

1. Scope

This test protocol is an integral part of the qualification plan in accordance with qualification master plan 0915 and is valid at the Ixberg site for the qualification of new and existing manufacturing and control equipment for pharmaceutical products. It does not relate to the qualification of computer systems.
This document must also be used if the qualification (or parts thereof) is to be carried out by external companies or consultants.

2. Test item

Subject of the test is the technical documentation of the facility to be qualified, and the internal SOPs Operation and servicing, inspection and maintenance. The SOP calibration SOP is not part of this test. Test protocol ...... should be used in this case.

3. Performance of test

1. Check if the technical documentation required in accordance with the DQ is available, legible, complete, technically correct and up-to-date, and is stored at the specified location (in accordance with SOP XYZ Documentation).

2. Check if the SOPs Operation and servicing, inspection and maintenance have been compiled and approved.

The acceptance criterion is: The documents are available at the locations specified according to SOP XYZ, and are complete, up-to-date and approved.

4. Test list

Test feature

Acceptance
criterion:
available,
up-to-date and
approved

Date

Signature

4.1 List of system components

4.2 Sectional drawings

4.3 Assembly/layout plans

4.4 Installation drawings for utilities supply and disposal

4.5 P&I diagrams (pipes and installation)

4.6 Measuring and control technology plan

4.7 Electrics diagram, wiring plans

4.8 Functional diagram, process flow diagrams (PFD), flow charts

4.9 Operating instructions

4.10 Spare parts list

4.11 Maintenance procedures, including intervals (supplier)

4.12 Calibration procedure and calibration report for works calibration

4.13 Assembly and disassembly instructions

Test feature

Acceptance
criterion:
available,
up-to-date and
approved

Date

Signature

4.14 Certificates for delivered materials used (e.g. factory test results)

4.15 Supplier certificates for system components, e.g. for validated software

4.16 Technical certificates, e.g. weld certificates

4.17 External certificates (e.g. pressure testing by TЬV)

4.18 CE conformity declaration or manufacturer's declaration

4.19 SOP Operation

4.20 SOP Servicing, inspection and maintenance

5. Test result

m Accepted

m  Not accepted, due to

Measures required

Record compiled

(Date/signature)

Record checked

(Date/signature)

Test result approved

(Date/signature)

1. Scope

This qualification report summarises the results of the IQ in accordance with qualification master plan 0915. It is valid at the Ixberg site for the qualification of new and existing manufacturing and control equipment for pharmaceutical products. It does not relate to the qualification of computer systems. This document must also be used if the qualification (or parts thereof) is to be carried out by external companies or consultants.

2. Test list

Test feature

Acceptance
criterion:
OK

Date

Signature

2.1 Examination for transport damage

2.2 Installation by experts in accordance with installation instructions

2.3 Assignment of an inventory number and inclusion in the equipment list

2.4. Log book created

2.5 Checking of materials and lubricants in accordance with test protocol IQ1

2.6 Checking of utilities supply in accordance with test protocol IQ2

2.7 Checking of measuring and control technology plans and initial calibration in accordance with test protocol IQ3

2.8 Checking of the calibration records in accordance with test protocol IQ4

2.9 Checking of P&I diagrams (pipes and installation) in accordance with test protocol IQ5

2.10 Checking of the pipes in accordance with test protocol IQ6

2.11 Checking of technical documentation, the operating SOP and the maintenance SOP in accordance with test protocol IQ7

2.12 Compilation of a cleaning SOP

2.13 Initial cleaning

2.14 Staff training

3. Comments

4. Qualification result

m Accepted

m  Not accepted, due to

Measures required

Detailed operating instructions

Maintenance manual for entire facility, partial facility and components

Operating instructions, fluid bed equipment

Logs

Preventative maintenance

Description

Exhaust ventilator

Capacity

6000 m3/h

Manufacturer

Lima

Type

SCL 3 U333

Serial number

Determine on-site

ID number

Determine on-site

220

Air inlet cover

X44

7

340

Product temperature

X54

34

675

Exhaust ventilator

X27

22

Description

Central device

Manufacturer

Siemens

Type

135 U/155 U

Serial number

Determine on-site

ID number

Determine on-site

e7.0

Exhaust ventilator

The input is high, if exhaust air ventilator electr. o.k.

a4.7

Steam valve

Input is high if supply air steam valve is open.

Software no.:

Designation:

Version:

Date:

Programmer:

Back-up copy:

Operating system:

Version:

Operating voltage

3 x 400 V

Control voltage

230v

Frequency

50 Hz

1

Emergency off button

Control panel

The facility halts operation as soon as the button is pressed. All motors and pumps are switched off and the valves for utilities supply are no longer supplied with electricity.

Spray device

stainless steel, 1.4401

Work tower, product contact parts

stainless steel, 1.4435

Type:

Separation rate:

Location:

Material:

Number of filters:

Facility/model no.:

Manufacturer:

Serial no.:

Signature:

Date:

1

Technical documents are complete:

2

The facility supplied is checked to verify completeness and compliance with the technical specifications (incl. safety features and equipment).

3

The facility supplied is assembled and connected correctly.

4

The hardware and software for the automated system has been compiled, documented and installed correctly.

5

The required operating procedures are available: cleaning, operation, maintenance.

6

A log book template has been compiled.

7

Initial cleaning has been carried out.

8

All deficiencies have been rectified.

9

Initial start-up has been successfully carried out.

Comments:

Date/signature:

Summary

During installation qualification (IQ) the equipment is checked and documented for compliance with the requirements profile (user requirements) and for proper installation. The SAT is a legally prescribed part of this. The technical documentation must correspond to the ACTUAL status. Changes during the qualification phase are not subject to the Change-Control procedures of pharmaceutical quality assurance.
IQ is an essential part of the qualification of a facility and must be successfully completed.