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Vladimir Veselov, Helen Roytman, and Lori Alquier: Installation Qualification

This document discusses the key aspects of equipment validation which includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). IQ establishes that the equipment is installed correctly according to specifications. OQ establishes process control limits to ensure the product meets requirements. PQ establishes that the equipment and process consistently operates within limits to produce a product meeting all requirements. Validation is important to confirm equipment and processes can consistently fulfill their intended use.

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Sandra Rodriguez
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68 views1 page

Vladimir Veselov, Helen Roytman, and Lori Alquier: Installation Qualification

This document discusses the key aspects of equipment validation which includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). IQ establishes that the equipment is installed correctly according to specifications. OQ establishes process control limits to ensure the product meets requirements. PQ establishes that the equipment and process consistently operates within limits to produce a product meeting all requirements. Validation is important to confirm equipment and processes can consistently fulfill their intended use.

Uploaded by

Sandra Rodriguez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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V l a d i m i r V e s e l o v, H e l e n Ro y tm a n , a n d Lo r i A l q u i e r

structed, placed, and installed to facilitate maintenance,


adjustment, cleaning, and use.
Validation means confirmation by examination and provisionofobjectiveevidencethattheparticularrequirements
for a specific intended use can be consistently fulfilled (1).
Therefore, equipment validation is one of the most
important components of process validation. Unfortunately, the QSR doesnt define which equipment is
considered to be major. It means that companies should
have procedures to define which equipment should be
validated, and which should not be validated. GAMP
5, system classification can be used for equipment categorization and defining which validation deliverables
are required (9).
An example of process validation documentation is
presented in Figure 3. Software validation and test method
validation are two widely separate topics that cannot be
covered in this paper.

INSTALLATION QUALIFICATION
Installation qualification is establishing by objective
evidence that all key aspects of the process equipment
and ancillary system installation adhere to the manufacturers approved specification and that the recommendations of the supplier of the equipment are suitably
considered (4).
Important IQ considerations are as follows:
Equipment design features (i.e., materials of construction cleanability)
Installation conditions (i.e., wiring, utilities,
functionality)
Calibration, preventative maintenance, cleaning
schedules
Safety features
Supplier documentation, prints, drawings and
manuals
Software documentation
Spare parts list
Environmental conditions (e.g., cleanroom requirements, temperature, humidity) (5).

OPERATIONAL QUALIFICATION
Operational qualification is establishing, by objective evidence, process control limits and action levels that result
in product that meets all predetermined requirements (4).
OQ considerations include the following:
Process control limits (e.g., time, temperature, pressure, line speed, setup conditions)
Software parameters
Raw material specifications
Process operating procedures
g x p a n d j v t . co m

Material handling requirements


Process change control
Training
Short term stability and capability of the process (latitude studies or control charts)
Potential failure modes, action levels and worst-case
conditions (failure mode and effects analysis [FMEA],
fault tree analysis) (4).
Frank defines OQ as studies which are designed
to challenge the process and process equipment, and
establish objective evidence that the process meets predetermined requirements throughout all anticipated
operating ranges (3).
The following are examples of OQ elements:
Verification of all systems and subsystem functions
Confirmation of all safety devices and systems
Software qualification
Evaluate impact of key parameters on the process (i.e.,
DOE, worst-case testing)
Measurement system suitability
Bias or repeatability and reproducibility of measurement systems
Operator training and qualification (3).

PERFORMANCE QUALIFICATION
Equipment performance qualification is establishing by objective evidence that the equipment, under
anticipated conditions, consistently performs within
the specified limits. The equipment PQ shall contain
evidence that the equipment is suitable for the process,
for which it is used.
Process PQ is establishing by objective evidence that
the process, under anticipated conditions, consistently
produces a product that meets all predetermined requirements (4).
The medical device guidance provides definitions for
process PQ and product PQ, as follows:
Process performance qualification: establishing
documented evidence that the process is effective
and reproducible.
Product performance qualification: establishing
documented evidence through appropriate testing
that the finished product produced by the specified process(es) meets all release requirements for
functionality and safety (5).
PQ considerations include the following:
Actual product and process parameters and procedures established in OQ
Acceptability of the product
Assurance of process capability as established in
OQ (4).
Journal of Validation Technology [SPRING 2012] 87

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