Just as measuring instruments need to be calibrated, it is important to demonstrate that the equipment and utilities in a pharmaceutical company are appropriate for their intended use and to prove that they are performing as expected. The activities undertaken to generate such evidence are called Qualifications.
Definition
Qualification may be defined as the act of proving and
documenting that a given equipment, process, or utility is correctly installed,
working properly, and consistently producing the expected results.
Qualification is a part of the process of validation;
however, qualification alone does not complete process validation.
Phases of Qualification
There are four major phases of qualification – Design
Qualification (DQ), Installation Qualification (IQ), Operational Qualification
(OQ), and Performance Qualification (PQ).
(a) Design Qualification is defined as documented
verification that the proposed design of equipment, systems, and facilities is
appropriate for the intended purpose. DQ must be performed whenever purchasing
new equipment; it should also be performed when existing equipment is going to
be used for any new application.
(b) Installation Qualification is defined as
documented evidence that the equipment, supporting utilities, and premises have
been built or installed in keeping with design specifications. IQ serves to
verify that equipment installation has been done as recommended by the
manufacturer, correctly, and kept in a suitable environment.
(c) Operational Qualification is defined as
establishing documented evidence that an equipment, facility, or utilities
functions as intended, in keeping with its operational specifications. OQ thus
helps to verify that the installed equipment works correctly.
(d) Performance Qualification is defined as
establishing documented evidence that the process works to consistently produce
a product that meets all the predetermined quality requirements. PQ helps to
verify that performance within the specified limits is as expected.
WHO Definitions
DQ - Documented evidence that the premises,
supporting systems, utilities, equipment, and processes have been designed according
to the requirements of good manufacturing practices.
IQ - The performance of tests to ensure that the
installations (such as machines, measuring devices, utilities, and
manufacturing areas) used in a manufacturing process are appropriately selected
correctly installed, and operated by established specifications.
OQ - Documented verification that the system or
subsystem performs as intended overall anticipated operating ranges.
PQ - Documented verification that the equipment or
system operates consistently and gives reproducibility within defined
specifications and parameters for prolonged periods.
Scope of Qualification Phases
|
Phase of
qualification |
Question it
answers |
|
Design
qualification |
Has it been
designed (or selected) correctly? |
|
Installation
qualification |
Has it been
installed (or built) correctly? |
|
Operational
qualification |
Is it working
correctly? |
|
Performance
qualification |
Is it
performing correctly within specified limits? |
Considerations While Doing Qualification
The following factors must be considered when doing
qualification:
1. Qualification must be performed as per predetermined and
approved qualification protocols.
2. Results must be recorded and should be a part of the
qualification reports.
3. Areas or rooms must be qualified before utilities;
utilities must be qualified before equipment.
4. Equipment can be used only after it has been qualified
and documented evidence shows that it is suitable for the intended purpose.
5. Qualification should be done in a logical sequence –
first DQ, then IQ, then OQ, and finally PQ.
6. Some stages of qualification may be performed by a third
party; however, the final responsibility of ensuring the qualification is done
as per GMP rests with the contract giver.
7. All documents related to the qualification process
(specifications, standard operating procedures, manuals, acceptance criteria,
and certificates) should be maintained.
8. All equipment, utilities, and systems must be maintained
in a qualified state at all times. When necessary, they must undergo periodic
requalification.
9. Validation of processes must be done using qualified
equipment only.
Requalification
When any equipment undergoes any kind of modification or
relocation on a scale that has a direct impact on the product quality, it must
undergo pre-qualification. This process must be handled with a documented
change control procedure, after due review and authorization.
Factory Acceptance Test and Site Acceptance Test
In some situations, equipment, or a system or utility may be
assembled fully or partially at some other site. In such cases, testing and
verification must be performed to ensure it is fit for dispatch, and results
must be recorded in the Factory Acceptance Test report before shipment of the
item.
After the shipment is received by the end user, tests must
be repeated to verify that the equipment, system, or utility is of acceptable
quality. The results of these tests must be recorded in the Site Acceptance
Test report.