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6.E Installation qualification (IQ)

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?

Figure 6.E-1 Definition of IQ

Definition of IQ (EU GMP Guideline, Annex 15)

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."

Installation qualification is the documented evidence that the equipment complies with the requirements made of it in terms of identity, installation, conformity with the guidelines and documentation. Installation qualification takes place after delivery of the equipment, at the same time as installation/assembly of the equipment at the place of installation. In the case of preassembled equipment, the installation qualification can be carried out, at least partially, at the supplier's premises (for example: water treatment system).

During installation qualification, the equipment is tested for conformity with the user requirements and for proper installation. During installation qualification, the overall scope of delivery of the equipment is identified and confirmation is given that all components of the delivery correspond to the specifications defined in the technical specification during the planning phase. The essential elements of installation qualification are summarised in figure 6.E-2.

Figure 6.E-2 Typical elements of installation qualification

Typical elements of installation qualification

  • 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

In this qualification phase, particular attention is placed on the technical documentation, the scope of which is to be described precisely during design qualification and which is to be provided by the supplier (see chapter 6.D Design qualification (DQ) and chapter 4.F Technical documentation). To ensure a good customer-supplier relationship, it is recommended that the exact time of provision of the technical documentation be defined. It is not always advisable to deliver this at the same time as the equipment, as foreseeable (planned) adaptations also involve changes to the documentation. Figure 6.E-3 shows an overview of the scope of the technical documentation.

Figure 6.E-3 Possible scope of the supplier's technical documentation

Possible scope of the supplier's technical documentation

  • 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

Acceptance at the supplier's premises (Factory Acceptance Test, FAT) is optional. Acceptance after delivery of the pharmaceutical process equipment (Site Acceptance Test, SAT) is legally required and includes all characteristics approved in the user specifications and specified in the technical specifications and order.

After acceptance of the equipment, the technical documentation must correspond to the ACTUAL status (as built). In the documentation, the manufacturer must take into account all changes made during the construction, assembly and start-up phases. Changes during the qualification phase are not subject to the change control procedure of pharmaceutical quality assurance. This begins after the "qualified" status has been assigned (often there is a project-specific change control procedure).

6.E.1 Examples of IQ plans

The general requirements of the qualification documentation are described in chapter 6.C Qualification documentation, including examples of test plans, see figure 6.C-4 and figure 6.C-5. There are numerous ways of structuring the individual documents. One possible systematic procedure is presented in this chapter. The forms may be used as a template for filling with the facility-specific test points. The documents are structured so that the qualification plan (list of the test points with acceptance criteria) and the test protocol (documentation of the test carried out) are summarised in a single document.

The following forms are included:

  • IQ test protocol: Materials and lubricants
  • IQ test protocol: Utilities (energy and media) supply
  • IQ test protocol: M & C points and initial calibration
  • IQ test protocol: Calibration records
  • IQ test protocol: P & I diagrams
  • IQ test protocol: Pipelines
  • IQ test protocol: Technical documentation
  • IQ qualification report

6.E.1.1 Materials and lubricants

Figure 6.E-4 IQ test protocol 1: Materials and lubricants 

Company

IQ qualification plan
IQ test protocol 1
Materials and lubricants

Page x v. y

QP-0815-4711

Qualification plan for facilities and equipment
for pharmaceutical products at the Ixberg site

valid from
01.10.2005

Qualification project no.

Facility/equipment

Inventory no.

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

6.E.1.2 Supply of (energy and media) utilities

Figure 6.E-5 IQ test protocol 2: Utilities (energy and media) supply 

Company

IQ qualification plan
IQ test protocol 2
Utilities (energy and media) supply

Page x v. y

QP-0815-4712

Qualification plan for facilities and equipment for pharmaceutical products at the Ixberg site

valid from
01.10.2005

Qualification project no.

Facility/equipment

Inventory no.

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

6.E.1.3 Measuring and control technology points and initial calibration

Figure 6.E-6 IQ test protocol 3: Measuring and control technology points and initial calibration 

Company

IQ qualification plan
IQ test protocol 3:
M & C (Measuring and control) points and initial calibration

Page x v. y

QP-0815-4713

Qualification plan for facilities and equipment for pharmaceutical products at the Ixberg site

valid from
01.10.2005

Qualification project no.

Facility/equipment

Inventory no.

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

6.E.1.4 Calibration records

Figure 6.E-7 IQ test protocol 4: Calibration records 

Company

IQ qualification plan
IQ test protocol 4: Calibration records

Page x v. y

QP-0815-4714

Qualification plan for facilities and equipment for pharmaceutical products at the Ixberg site

valid from
01.10.2004

Qualification project no.

Facility/equipment

Inventory no.

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

6.E.1.5 P & I diagrams

Figure 6.E-8 IQ test protocol 5: P & I diagrams

Company

IQ qualification plan
IQ test protocol 5: P & I diagrams

Page x v. y

QP-0815-4715

Qualification plan for facilities and equipment for pharmaceutical products at the Ixberg site

valid from
01.10.2005

Qualification project no.

Facility/equipment

Inventory no.

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

6.E.1.6 Pipes

Figure 6.E-9 IQ test protocol 6: Pipes 

Company

IQ qualification plan
IQ test protocol 6: Pipes

Page x v. y

QP-0815-4716

Qualification plan for facilities and equipment
for pharmaceutical products at the Ixberg site

valid from
01.10.2005

Qualification project no.

Facility/equipment

Inventory no.

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

6.E.1.7 Technical documentation

Figure 6.E-10 IQ test protocol 7: Technical documentation 

Company

IQ qualification plan
IQ test protocol 7:
Technical documentation

Page x v. y

QP-0815-4717

Qualification plan for facilities and equipment
for pharmaceutical products at the Ixberg site

valid from
01.10.2003

Qualification project no.

Facility/equipment

Inventory no.

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

6.E.1.8 IQ report

Figure 6.E-11 Qualification report IQ  

Company

Qualification report IQ

Page x v. y

QP-0815-4720

Qualification plan for facilities and equipment
for pharmaceutical products at the Ixberg site

valid from
01.10.2003

Qualification project no.

Facility/equipment

Inventory no.

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

6.E.2 Example: Fluid bed equipment

The measures that must be carried out (sometimes using forms) during the installation qualification are listed below, using fluid bed equipment as an example. Computer validation measures are dealt with in chapter 9 Computer Validation.

Technical documentation

To complete the technical documentation, documents concerning the facility or its components must be available. These are required for the installation, operation and maintenance of the facility and must be checked as part of the installation qualification and documented in the form (see figure 6.E-12).

Figure 6.E-12 IQ form - documentation

Document

available
yes/no
Drawing no. if relevant

Responsible for supplementations, changes, etc.

Date/
signature

Detailed operating instructions

     

Maintenance manual for entire facility, partial facility and components

     

Operating procedures (SOPs)

The procedures required to operate the facility or its components must be checked (e.g. calibration, operating, maintenance and cleaning procedures). Attention must be paid to the personnel training documentation (see chapter 2.C Training). The form provides confirmation that the check has been carried out (see figure 6.E-13).

Figure 6.E-13 IQ form - SOP

Title of operating procedure

No. /Rev. no.

Date of implementation

Training
confirmed

checked
Date/
signature

Operating instructions, fluid bed equipment

       

Logs

       

Preventative maintenance

       

Risk analysis

The facility and its operating functions are assessed and tested during the risk analysis. Critical areas during operation, possible errors and causes of the various risks, as well as the steps that must be taken to minimise the risks, must be defined and recorded. The compiled risk analysis is to be enclosed with the IQ report (see chapter 6.B.6 Risk analysis).

Facility components

The technical data of the facility or its components is to be checked against the functional specification and documented in the form. The available ID numbers of the individual facility components are registered during this check (see figure 6.E-14).

Figure 6.E-14 IQ form - facility components

   

Date/signature

Description

Exhaust ventilator

 

Capacity

6000 m3/h

 

Manufacturer

Lima

 

Type

SCL 3 U333

 

Serial number

Determine on-site

 

ID number

Determine on-site

 

Terminal strip

The electrical circuit diagram must be used to check whether the wiring of the facility's components is correct. A random check is sufficient. The circuits to be checked are specified in the form. If no deviations from the manufacturer's documentation are found during the check, the circuit diagram may be accepted. Where deviations are found, the circuit diagram must be reviewed. The results must be documented in the form (see figure 6.E-15).

Figure 6.E-15 IQ form - terminal strip

Page no.

Checkpoint

Terminal strip

Terminal no.

Result
Date/ Signature

220

Air inlet cover

X44

7

 

340

Product temperature

X54

34

 

675

Exhaust ventilator

X27

22

 

Hardware installation

The system hardware must be checked by inspecting the hardware configuration, the wiring and the electrical supply. The results are documented in the form (see figure 6.E-16).

Figure 6.E-16 IQ form - hardware

   

Date/signature

Description

Central device

 

Manufacturer

Siemens

 

Type

135 U/155 U

 

Serial number

Determine on-site

 

ID number

Determine on-site

 

Input/output list

Checks must be carried out to verify that the control has been correctly connected to the functional modules and facility sensors, and this must be documented. If the manufacturer delivers an I/O list, a random check on 15% of I/Os will suffice. If no deviations from the manufacturer's documentation are found during the check, the list may be accepted. If deviations are found, all I/Os must be checked. The results must be documented in the form (see figure 6.E-17).

Figure 6.E-17 IQ form - I/O list

PLC
Input/Output

Signal transmitter/receiver

Description

Date/
signature

TARGET

ACTUAL

     

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 installation

The software installation must be documented. The designation, type, name and version number (date) of the software must be noted. Similarly, the manufacturer and/or developer and the back-up system must be recorded. The results are documented in the form (see figure 6.E-18).

Figure 6.E-18 IQ form - software

Software no.:

                                                                                                

Designation:

                                                                                                

Version:

                                                                                                

Date:

                                                                                                

Programmer:

                                                                                                

Back-up copy:

                                                                                                

Operating system:

                                                                                                

Version:

                                                                                                

Initial cleaning

Once installation has been carried out for the first time, facilities or their components must be thoroughly cleaned in accordance with the relevant operating procedures and confirmation provided to show that this has been carried out.

Inspection of utility connections

The connected loads of all utilities to and from the facility must be compared with the manufacturer's data. The connections must also be checked to make sure that they have been carried out correctly. The results must be documented in the form (see figure 6.E-19).

Figure 6.E-19 IQ form - utilities

Electrical
connection

Connection
specifications + tolerances, if required

Connection
(measured)

Date/signature

Operating voltage

3 x 400 V

   

Control voltage

230v

   

Frequency

50 Hz

   

Safety devices and locks

A list of the safety devices and locks included with the facility or its components must be compiled with reference to the manufacturer's specifications. When qualifying the installation, checks must be carried out and documented to verify that all facilities are available. The actual function of the facilities is checked within the scope of the operational qualification. The results of the installation qualification are documented in the form (see figure 6.E-20).

Figure 6.E-20 IQ form - safety

No.

Facility

Facility
component

Description

available yes/no

Date/signature

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.

   

Construction and installation materials

Materials used in the facilities or any of their components that come into contact with raw materials, and intermediate or final products, must be listed in the form (see figure 6.E-21).

Figure 6.E-21 IQ form - materials

Component/part

Material
specified

acceptable

visually checked date/signature

Spray device

stainless steel, 1.4401

   

Work tower, product contact parts

stainless steel, 1.4435

   

Filter list

A list of the filters required for operation of the facility must be compiled. For sterile filters, copies of the test reports and the SOP used for implementation are also required. The filters are listed on the form (see figure 6.E-22).

Figure 6.E-22 IQ form - filters

Type:

                               

Separation rate:

                               

Location:

                               

Material:

                               

Number of filters:

                               

Facility/model no.:

                               

Manufacturer:

                               

Serial no.:

                               

Signature:

                               

Date:

                               

Measuring and control points (M&C points)

A list must be compiled of the available M&C points that includes the numbers of M&C points, the relevant manufacturer, the date of the last calibration and the recalibration interval. The documentation of the last calibration must be included with the IQ report.

IQ - site acceptance test

A summary of the results obtained during the installation check is presented in the site acceptance test IQ. The results are checked using the form (see figure 6.E-23).

Figure 6.E-23 IQ form - site acceptance test 

No.

Description

Date/signature

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:

Deficiency report

Deviations identified during the installation qualification must be documented in the deficiency report. The operator defines the measures required to rectify the deficiencies or deviations; names the departments or persons responsible; specifies deadlines by which the deficiency must be rectified at the latest; and authorises implementation of the measures. Rectification of the deficiencies found must be documented in the form (see figure 6.E-23).

It must be ensured that changes made, as a result of rectifying deficiencies that have been determined, are assessed and documented in accordance with the established change control procedures, and also ensured that a requalification is carried out as required. The regulations governing requalification are laid down in the relevant operating procedures.

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.


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