‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

● BUSINESS MANAGEMENT
● QUALITY MANAGEMENT
● MARKETING
● PERSONNEL
● DOCUMENTATION
● ENGINEERING
▸ R&D
▸ PROCESS EQUIPMENT
▸ UTILITIES
▸ CLEAN ROOM
▾ LOGISTICS
● GSP

● GDP

▸ PROCESS
● QUALITY CONTROL
● INFORMATION TECHNOLOGY
● OUTSOURCED ACTIVITIES
● SELF INSPECTION
● GACP
● GPP
▸ GMP BEST PRACTICES
● TERMINOLOGY
● FORUM

NEWS

ABOUT CONTACTS FORUM

Examples of facility qualification

In this chapter, the various components of facility qualification are illustrated by practical examples.

The general procedure to follow when carrying out qualifications is shown in chapter 6 Qualification.

https://gmpua.com/World/Ma/04/e_en.htm 1/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

1 Design qualification
All essential parameters for the subsequent use of pharmaceutical process equipment are defined in the specification (also known as user requirements).
Together with the technical specification (the approved supplier specification), this is an important part of the design qualification (DQ). Checks are carried out
throughout the remaining qualification modules (IQ/OQ) to verify whether the facility meets the requirements of the specification.

Elements of the facility specification

Direct references to standards and rules and regulations

Description of facility
Functionality
Procedural description
Accessory
Mechanical components
Version
Dimensions
Materials
Control and process monitoring
Supply of energy and utilities
Constructional prerequisites
Installation, start-up, acceptance tests
Documentation, validation, qualification
Appendix: drawings, internal guidelines

Figure 1 Elements of the facility specification

In the following, the specification for a washer is shown as an example:

Preliminary remark
This specification describes the minimum delivery scope for a facility that cleans, disinfects and dries equipment intended for use in the pharmaceutical industry.
This document does not provide a comprehensive or complete description of the system to be delivered. Instead, it defines a minimum technical standard and
refers to standards and specifications applicable in this case.

Direct references to standards and rules and regulations

The following standards and rules and regulations must be taken into consideration during the design and construction of automatic washers. This also applies
to specifications not stated here that are relevant to the construction of the facility.

EU GMP Guideline of good manufacturing practice for medicinal products

Current Good Manufacturing Regulations and Guidelines (cGMP) of US Food and Drug Administration (FDA)
European Pharmacopoeia
DIN standards
VDE guidelines
VDI 2890: scheduled maintenance; instructions for the compilation of maintenance and inspection plans
Trade association accident prevention regulations
Description of facility
Functionality: automatic cleaning, drying and disinfection of pharmaceutical equipment. Cleaning is carried out using water with varying qualities to which
cleansing agent is added depending on the programme step. The final rinse must be carried out using purified water.
Description of procedure: A standard cleaning procedure as shown in figure 2 should be possible. The tenside-based cleaners are specified. Water and air
temperatures must not exceed X °C.
Accessories: washing baskets

Rinsing programme

Prewash
Main wash with tenside-based cleaner
Repeat main wash cycle, as required
Rinsing in cycle
Clear rinse with purified water in single operation
Drying
Cooling

Figure 2 Rinsing programme

Mechanical components
Full drainage of machine and pumps; no exposed heating elements; variable partitioning of internal compartment
Pharma-compliant version characterised by:
use of material 316L for all surfaces and pipes coming into contact with fluids,
use of diaphragm valves and tri-clamp connections,
dead volume-free and fully drainable installation,
prevention of mixup or reverse contamination and
use of a validatable process control and machine documentation.

https://gmpua.com/World/Ma/04/e_en.htm 2/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

2 programmable liquid metering pumps for cleaning fluids with metering monitoring function.
Drying with high-performance blower, HEPA filter in the drying circuit not required. Suction of drying air from production room including filtering in accordance
with clean room grade D. Discharge of drying air via roof.
Condensate drainage in venting line to prevent backflow contamination
Dimensions
Materials: washing compartment and inner face of door: 316L (alternatively 1.4401). Cladding material: 1.4301. The materials used for seals and tubes must
correspond with the recommendations of the US Food and Drug Administration (FDA). Works certificates for the above materials must be included in the
delivery.
Control
Freely programmable control (microprocessor control or PLC). The programme should be structured in a modular fashion. Headings for the individual
programme modules must be provided.
Plain text display in the relevant language
Display of washing programme, current programme step, temperature of washing compartment and remaining running time.
It must be possible to print out the programmes and all their parameters (if required, printer to be connected).
Self-diagnosis, programme and malfunction statistics
The control should incorporate a memory that accommodates several (>10) wash programmes that may be called up individually.
The machine must stop if the preset parameters are not complied with. The operator should then be provided with the reason why the process was cancelled.
When the machine is restarted, the entire wash programme must be repeated.
Process monitoring
Monitoring of the following process parameters with display option and limit value monitoring with alarm or machine stop.
Temperature of rinsing water
Pump pressure (circulatory pump)
Drying temperature
The sensors must be readily accessible and removable for calibration purposes (cable length) and it must be possible to calibrate these with the entire
measurement chain.
Dosage monitoring of detergent pumps
Sampling tap for water samples
Error display for important functions and utilities
A connection that enables the machine to be regularly requalified must be provided. For example, a connection that can be used to log the progress of the
relevant parameters during a rinsing cycle via an on-site chart recorder.
Supply of energy and utilities
Connections for the following water types: purified water, 65 °C, connection to loop provided by installation location; drinking water both warm and cold.
Drainage via open funnel siphon to prevent backflow contamination
Electrical connection: 400 V/50 Hz
Steam connection
Connection to exhaust line provided by installation location
Constructional prerequisites
The equipment must be installed in a wash room. The particulate and microbiological loading of the room must correspond with clean room grade D. The
nominal room temperature must be 20 °C +5/-2 °C, at 50% r.h.. Data on the required limits at the installation location (temperature, rel. humidity, electrostatic and
magnetic influencing parameters) must be supplied.

Installation, start-up, acceptance tests

The scope of delivery includes:

Free delivery and placing at site (supervision of placing as minimum)

Complete assembly and start-up incl. test operation
Instruction of operating personnel
Necessary acceptance tests: the contract giver reserves the right to audit the manufacturing, programming and quality assurance at the premises of the contract
acceptor.
The "pre-delivery check", otherwise known as the Factory Acceptance Test (FAT), at the manufacturer's premises guarantees the necessary manufacturing quality
and ensures that the function tests are carried out.

The final acceptance, otherwise known as the Site Acceptance Test (SAT), by the contract giver takes place at the installation location once assembly and start-
up have been completed and the operating personnel have been instructed. It must be verified that

the delivery of the facility is complete and correct,

the documentation is complete,
the installation is correct,
the cleaning and auxiliary programmes specified by the operator and also the safety devices are functioning faultlessly,
the locks and alarms are functioning faultlessly,
the installation and function of the measuring equipment is correct and
the initial calibration of the sensors was carried out at the installation location (if carried out by contract acceptor)
The basis for the pre-delivery check and the site acceptance test is a reference programme to be compiled by the supplier according to the specifications of the
contract acceptor containing all elements of the subsequent cleaning task. This programme also serves as the basis for carrying out function tests within the
scope of the operational qualification.

Furthermore, three cleaning cycles with contaminated equipment are to be carried out to assess the success of the acceptance test using the following criteria:

Visually clean / analytically clean

Visually dry
Surface quality of the materials washed
Analysis of the cleansing agent residues (see chapter 8.E.2 Calculation of cleansing agent residues)

https://gmpua.com/World/Ma/04/e_en.htm 3/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

Documentation, validation, qualification

The technical documentation to be supplied for the purposes of qualifying the facility can be found in the basic documents table. (see figure 3, figure 4, figure 5).

2 Installation qualification
The basic structuring and detailed description of an installation qualification are not dealt with here. This information can be found in the chapter entitled
Qualification. (See chapter chapter 6 Qualification.) Only the measures that must be carried out (partly 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 3).

available
Responsible for
yes/no, Date/
Document supplementations,
drawing no. signature
changes, etc.
where applicable

Detailed operating instructions

Maintenance manual for entire facility, partial facility and components

Figure 3 IQ form - documentation

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
4).

checked
No. / Date of Training
Title of operating procedure Date/
Rev. no. implementation confirmed
signature

Operating instructions, fluid bed equipment

Logs

Preventative maintenance

Figure 4 IQ form - SOP

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 completed risk analysis must be included alongside 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 5).

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

Figure 5 IQ form - facility components

Terminal strip table

https://gmpua.com/World/Ma/04/e_en.htm 4/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

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).

Result
Page no. Checkpoint Terminal strip Terminal no.
Date/signature

220 Air inlet cover X44 7

340 Product temperature X54 34

675 Exhaust ventilator X27 22

Figure 6 IQ form - terminal strip table

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 7).

Date/signature

Description Central device

Manufacturer Siemens

Type 135 U/155 U

Serial number Determine on-site

ID number Determine on-site

Figure 7 IQ form - hardware

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 8).

PLC Date/
Signal transmitter/receiver Description
Input/Output signature

NOMINAL ACTUAL

e7.0 Exhaust ventilator Input is high for electr. exhaust fan O.K.

a4.7 Steam valve Input is high if supply air steam valve is open.

Figure 8 IQ form - I/O list

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 9).

Software no.:

Designation:

Version:

Date:

Programmer:

Back-up copy:

Operating system:

Version:

https://gmpua.com/World/Ma/04/e_en.htm 5/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

Figure 9 IQ form - software

Initial cleaning
Once installation has been completed 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 10).

Electrical Connection Date/

Connection specifications + tolerances, if required
connection (measured) Signature

Operating voltage 3 x 400 V

Control voltage 230 V

Frequency 50 Hz

Figure 10 IQ form - utilities

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 11).

Facility available Date/

No. Facility Description
component yes/no signature

1 Emergency off Operator control The facility halts operation as soon as the button is pressed. All motors and pumps are switched
button panel off and the valves for media supply are no longer supplied with electricity.

Figure 11 IQ form - safety

Construction and assembly materials

Materials used in the facilities or any of their components that come into contact with raw materials, intermediate or final products, must be listed in the form
(see figure 12).

Material
Component/part acceptable visually checked date/signature
specified

Spray device stainless steel, 1.4401

Work tower, product contact parts stainless steel, 1.4435

Figure 12 IQ form - materials

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 13).

Type: Separation efficiency:

Location: Material:

Number of filters: Facility/model no.:

Manufacturer: Serial no.:

Signature: Date:

Figure 13 IQ form - filters

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.
https://gmpua.com/World/Ma/04/e_en.htm 6/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

IQ - site acceptance test

A summary of the results obtained during the installation check is presented in the IQ site acceptance test . The results are checked using the form (see figure
14).

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:

Figure 14 IQ form - site acceptance test

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 14).

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. (See chapter chapter 6 Qualification.)

3 Operational qualification
The basic structuring and detailed description of an operational qualification are not dealt with here. This information may be found in the chapter entitled
Qualification (see chapter chapter 6 Qualification). Only the measures that must be carried out (partly using forms) during the operational qualification are listed
below using fluid bed equipment for illustration purposes. Computer validation measures are dealt with in chapter 9 Computer Validation.

Testing equipment required for qualification

The testing equipment required to carry out the operational qualification (OQ) must be listed (see figure 15). It must be ensured that calibration can be traced
back to the standards of the NIST (National Institute of Standards and Technology) or equivalent organisations. It must be checked that the time interval prior to
recalibration has not been exceeded. Copies of the documents from the last calibration of the testing equipment used must be included with the
equipment/qualification documents.

Description Calibration Date of last Date/

Manufacturer Serial number
of equipment interval calibration signature

Stopclock Solex

Multimeter Fluke

Figure 15 OQ form - testing equipment

Calibrations
The quality-relevant MC points (measuring and control points) have been named. A copy of the compiled list can be found in the installation qualification report.
The measuring circuits must be calibrated before the operational qualification is carried out. A copy of the calibration report is filed with the OQ report. (See
chapter 4.G Calibration.)

Alarms
All alarms that respond to malfunctions in the facility must be checked by simulating the appropriate malfunctions. The type of simulation must be described in
the form and documented. Care must be taken to ensure that only authorised personnel carry out these simulations.

Safety devices/locks
https://gmpua.com/World/Ma/04/e_en.htm 7/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

All safety devices in the facility must be checked to make sure that they are functioning correctly. "Safety devices" means all equipment that protects the
operator from personal injury and the facility from improper handling. The tests must be documented with the aid of the form (see figure 16).

functioning
Date/
No. Facility Description correctly
signature
yes/no

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

Press the emergency off button when the facility is in operation:

All motors stop moving

The valves for the utility supply are closed.

Figure 16 OQ form - safety

Flow rate test

The facility is started with a flow rate of 1000 mі/h without heating output and product (this corresponds with the minimum capacity). The air velocity is
measured and recorded at three different measuring points. This measurement is then repeated with a flow rate of 3500 mі/h and 6000 mі/h. The values
determined at the various measuring points are compared with one another and assessed. The analysis is documented using a form.

Flow rate control

A check must be carried out to verify that the flow rate is being controlled correctly using three different flow rates. This involves starting the facility with a flow
rate of 1000 m3/h without heating output and product. This setting is maintained for 15 minutes. The flow rate is then increased to 3500 m3/h for a further
15 minutes and then finally to 6000 m3/h for 15 minutes. During this time the control must maintain a stable value that falls within the specified range. The
tolerance values are specified in a form where the results are also documented.

Spray rate
The facility is to be prepared as if a product cycle was about to be carried out, it is started with a flow rate of 2000 m3/h without heating and product. The spray
medium to be used is water. Measurements are carried out for 10 minutes with the minimum, 50 % and the maximum spray rates respectively. The spray quantity
is determined by establishing the tare weight. The trial must be carried out three times for each spray rate which must not deviate by more than ±5 %. The tests
are documented in the form.

Heat distribution
To check the heat distribution, the facility must be prepared as if a product cycle was about to be carried out and must be started with a flow rate of 3000 m3/h
without a product load. The temperature is set at 50 °C. Following a five minute warm-up phase, the temperature is measured at 5 different points above the
sieve screen for 10 minutes. None of the measured values may deviate by more than ±5 °C from the average value determined above the screen. The trial is
repeated at 80 °C and 110 °C. The tests are documented in a form.

Temperature control
The temperature control is checked without a product with a flow rate of 5000 m3/h, at 50 °C, 80 °C and 110 °C respectively. After the five minute warm-up phase
the temperature must settle down to a constant level which is maintained for 10 minutes. The same procedure is then carried out for temperatures of 80 °C and
110 °C respectively and the control checked. The deviations must not be more than ±5 °C from the preset value. The results must be documented. A printout of
the plot must be included with the OQ report.

Screen masks
Checks must be carried out to verify whether the screen masks perform the functions they have been assigned. It must be ensured that the operational
parameters can be modified within their assigned limits. It must be possible to store new formulations with the programmed operational parameters and call
these up again. The temperature, humidity and pressure values displayed are checked during calibration. A hardcopy of each screen mask must be made and
included with the form.

Equipment functions
This involves testing specific functions of the facility such as the "on/off" or "raise/lower" operator control elements. The decision as to which tests should be
carried out is influenced by insights gained from the risk analysis (see chapter 6.B.6 Risk analysis). The tests are documented in a form.

Product cycle
To check the entire sequence of functions in context, a trial run is carried out with the product. The manufacturing instructions for the product must be used as
the basis for the trial run.

Results
Product cycle correct:
yes/no

The product cycle was implemented in accordance with the manufacturing instructions.

It was possible to implement the product cycle without interruption.

The prescription steps were processed correctly.

https://gmpua.com/World/Ma/04/e_en.htm 8/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

The step enabling conditions were achieved and identified.

No process-related malfunctions occurred.

The preset process parameters were complied with.

The product was checked in accordance with existing guidelines and corresponds with the specifications.

Comments:

Date/signature:

Figure 17 OQ form - product cycle

The final product is checked in accordance with the relevant test procedure. The implementation and the test results must be documented (see figure 17). The
product cycle data may be used for the performance qualification and validation.

Batch record
The recording of a batch starts when the process begins and ends when the container is lowered. It must be ensured that the process data entered and the
measured values gathered are reproduced correctly in the batch record . To check this, the batch record for the test run described above must be recorded
manually in the form. Once the trial has ended, the batch record which is generated automatically is compared with the manually recorded data. There must be
no deviations.

Data backup
Checks must be carried out to determine how the system responds in the event of a power/utilities failure. It must be ensured that the operating data that has
accumulated up to this point is not lost in the event of a sudden power/utilities failure. The facility must also be capable of continuing with the last process
status following restoration of the power/utilities and final confirmation. There must be no deviations in the parameters set or the process data. The test is
documented using the form.

Access protection
It must be demonstrated that unauthorised individuals cannot access the system and manipulate data. A check must be carried out to determine whether
operational parameters can only be modified by authorised personnel. The analysis is documented using the form.

Deficiency report
Deviations identified during the operational qualification must be documented in the deficiency report. The operator defines the measures required to rectify the
deficiencies or deviations; names the departments and/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 identified must be documented.

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 a requalification carried out as required.

https://gmpua.com/World/Ma/04/e_en.htm 9/10
‫ م‬5:30 2024/‫‏‬5/‫‏‬8 Examples of facility qualification

Navigation
■ GXP
■ ACTIVE PHARMACEUTICAL INGREDIENTS
■ BIOTECHNOLOGY
■ ENVIRONMENTAL MANAGEMENT

■ ABOUT
■ CONTACTS
■ FORUM

© 2018
Licence Privacy Policy Terms Of Service

https://gmpua.com/World/Ma/04/e_en.htm 10/10