Qualification of Existing Facilities, Systems, Equipment and Utilities

27/11/2022, 12:00 Qualification of existing facilities, systems, equipment and utilities - Pharmaceutical Guidance
Qualification of existing facilities, systems, equipment and utilities

 Pharmaceutical Guidanace  December 4, 2020  Validation & Qualification  1,895 Views
Qualification of existing facilities, systems, equipment, and

utilities
An existing facility has a mixture of new fully qualified equipment (DQ, IQ, OQ, PQ) and partially qualified/
unqualified equipment.
Through many years of use, it can usually be shown that facilities, systems, equipment, and utilities can
function to varied requirements. Nevertheless, cGMPs necessitate that, items that have an impact on the
quality of the intermediate or API, should be qualified.
Formal qualification is the basis for the related activities such as validation associated with new product
introduction or validation of existing processes.
Qualification should provide documented verification that the parameters defined as critical for operation
and maintenance are adequately controlled.
It is essential that the qualification is practical and achievable, adds value to the project, and is concentrated
on the critical elements of the system.
It is recommended that a risk assessment approach is used to define the depth of qualification. There
should always be a reasonable proportionality between risk for the product quality, the amount of measures
to be taken, and documentation to be prepared (.e.g. stage of manufacture, regulatory status, and intended
use)
Regulatory requirements The ICH Q7A
The requirement is that facilities, systems, equipment and utilities are properly qualified and maintained to
assure data and product integrity.
PIC/S Guidance:
“While it is not possible to undertake the details of an Installation Qualification for established equipment nor
the detailed approach for an Operational Qualification, nevertheless there should be data available that
support and verify the operating parameters and limits for the critical variables of the operating equipment.
Additionally, the calibration, cleaning, preventative maintenance, operating procedures and operator training
procedures for the use of the equipment should be documented and in use as standard operating
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procedures (SOPs).”
Risk Assessment 
RA is a formal and systematic approach to identify GMP risks related to equipment and supporting systems.
It is a very helpful tool that can be applied to plant, equipment, and systems which have been in use for
many years.
It is recommended that the manufacturing instructions are used in combination with general GMP
requirements (e.g. design, documentation, risk for contamination, usage in final dosage form, etc.) as the
basis for the risk assessment.
Each manufacturing step can be assessed individually with respect to critical operations/activities (e.g.
stirring speeds, temperature ranges, pressure, hygroscopy, open product handling, etc.).
Process descriptions, development reports, product quality reviews and process validation reports can
assist in identifying the quality critical operations and parameters.
Equipment risk assessment can be performed by equipment train or by individual processing units and
supporting systems. A grouping strategy of similar/identical processing units can be used.
Unit operations or functions could be assessed according to the following scheme:
Does Function / Operation directly impact product quality?
Does Function / Operation create (electronic) data which are the basis for GMP related activities?
Would malfunction impact directly on product quality?
Does a measuring instrument control or measure quality critical processing steps/parameters?
Does Operation / Installation cause contamination risk of product or of the facility environment?
Are materials of construction in direct contact with product?
If any of the above questions are answered with „yes“, the operation/function is considered as GMP-
relevant. During risk assessment, the probability of occurrence and detectability should be considered and
measures to reduce the risk identified.
An example of a technical GMP risk assessment is given below:
The objective of the risk assessment
– Identification of potential risks related to products, preventive/corrective actions, and checks related to
qualification.

Scope
– Identification of processing unit and location.
General
– Description of the processing unit (size, configuration, supporting systems
(heating/cooling/vacuum/nitrogen/solvents, etc.), type of products produced (e.g. APIs, API intermediates,

drug product application, etc.), possible connections with other processing units (like filters, centrifuges,
supporting systems, containers, gases, water systems, waste gases, etc.),
System boundaries
– Description of what will be addressed during the risk assessment Related documents/baseline documents
for risk assessment.
– P &IDs, engineering documents, SOPs, deviations.
The risk assessment can be performed using a template, where typical working steps /activities for the
processing units are listed (including instrumentation and control systems).
An example is given below for a reactor:
– Stirring
– Crystallisation
– Supporting systems
– Heating/cooling
– Charging / discharging
– Evacuation
– Sampling
Additionally, materials of construction with direct product contact are assessed and critical measuring `and
control devices are identified that need to be calibrated.
Procedure
It is recommended that the following activities are carried out during qualification of existing equipment: 
1. Collect flow diagrams and matrixes which can be useful in providing an overview and monitoring tool. A
flow scheme for the introduction of a new product into an existing plant is shown below.
2.0 Refer to the below table which indicates the activities in the qualification.
Table
Flow Scheme of Activities in the Qualification

SNo. Activity Examples Document
Define qualification scope including

1.0 – VMP (QP)
systems and equipment
2.0 Execute Risk Assessment (RA) – RA matrix
Set-up of a Qualification Matrix with

3.0 – Qualification Matrix (IQ)
all systems, components
4.0 – Datasheet(s) / Technical

Description / Certificates (e.g.
material of construction)
– Drawing(s)
– Parts list(s) Engineering Files
– Installation instructions and Documentation
– Operating instructions Matrix
– Maintenance instructions
and records
Review historical documents and
– Calibration instructions and
production data
records
– Copy of supplier’s proposal,
order and order confirmation Process Validation and
– Commissioning and test Production Campaign

Reports
plans
– Electrical diagrams
– Batch records and analytical
results and plant parameter
data
Collect and review all historical
deviations, changes related to – Deviation Reports Change Evaluation Report

equipment/systems, and failures if Reports Complaint Files Annual Product Review
available
Reviewing the available procedures – Maintenance, calibration SOP’s and working

around the equipment/system procedures instructions

Review the qualification/accuracy of Qualification Matrix (OQ,
5.0 OQ, PQ
equipment and implement OQ/PQ PQ)
Updating the available procedures Maintenance, calibration, and SOP’s and working
6.0
around the equipment/system operating procedures. instructions
Prepare Validation Report / Validation Master Report

7.0 –
Qualification Report (or equivalent reports)
Have basis for on-going Change

8.0 – –
Control
3.0 Prepare a Validation Master Plan (VMP) and/or Qualification Plan (QP). A section of the Validation
Master Plan should cover the qualification of plant and equipment.
4.0 Collect, review and update related documentation to the equipment (procedures, change control,
historical production data, process deviations). This activity may be done using a documentation matrix,
example as shown below-
5.0 Execute the Risk Assessment Process to identify which items of equipment require qualification. The
Risk Assessment Process will be carried out on every system or sub-system.
6.0 Prepare a Qualification Matrix for IQ. Please see below –
The weigh scale and solvent meter has still to be calibrated.
The weigh scale and solvent meter have still to be calibrated.
7.0 Update the detailed line diagram of the plant by checking it against the physical plant. The existing
Installation Qualification (IQ) and engineering files should be reviewed and updated.
8.0 Prepare a further Qualification Matrix to review the accuracy and range of equipment/ instruments and
identify items requiring OQ and PQ . Please see below –
9.0 Perform the OQ and PQ to complete the qualification.
10.0 Ongoing change management should be implemented after reporting and approval of all activities in
the VMP and/or QP.
Reference: Guidance on Qualification of existing facilities, systems, equipment and utilities(APIC)
Pharmaceutical Guidanace
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of
rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco
remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC,
TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently
leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube
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27/11/2022, 12:00 Qualification of existing facilities, systems, equipment and utilities - Pharmaceutical Guidance

Qualification of existing facilities, systems, equipment, and

introduction or validation of existing processes.

on the critical elements of the system.

Regulatory requirements The ICH Q7A

basis for the risk assessment.

assist in identifying the quality critical operations and parameters.

Unit operations or functions could be assessed according to the following scheme:

Does Function / Operation directly impact product quality?

Would malfunction impact directly on product quality?

Does a measuring instrument control or measure quality critical processing steps/parameters?

Are materials of construction in direct contact with product?

measures to reduce the risk identified.

An example of a technical GMP risk assessment is given below:

The objective of the risk assessment

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– Identification of processing unit and location.

– Description of the processing unit (size, configuration, supporting systems

(heating/cooling/vacuum/nitrogen/solvents, etc.), type of products produced (e.g. APIs, API intermediates,

supporting systems, containers, gases, water systems, waste gases, etc.),

– P &IDs, engineering documents, SOPs, deviations.

processing units are listed (including instrumentation and control systems).

An example is given below for a reactor:

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Define qualification scope including

2.0 Execute Risk Assessment (RA) – RA matrix

Set-up of a Qualification Matrix with

4.0 – Datasheet(s) / Technical

– Installation instructions and Documentation

– Operating instructions Matrix

– Commissioning and test Production Campaign

Collect and review all historical

deviations, changes related to – Deviation Reports Change Evaluation Report

Reviewing the available procedures – Maintenance, calibration SOP’s and working

Prepare Validation Report / Validation Master Report

Have basis for on-going Change

Master Plan should cover the qualification of plant and equipment.

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6.0 Prepare a Qualification Matrix for IQ. Please see below –

The weigh scale and solvent meter has still to be calibrated.

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The weigh scale and solvent meter have still to be calibrated.

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9.0 Perform the OQ and PQ to complete the qualification.

the VMP and/or QP.

Reference: Guidance on Qualification of existing facilities, systems, equipment and utilities(APIC)

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