Validation

An Introduction to Pharmaceutical
Validation , Calibration
and Qualification

By: Ahmed Abdelaziz

 Contents

➢ Meaning of Validation
➢ Meaning of Calibration
➢ Meaning of Verification
➢ Meaning of Qualification
➢ Purpose of Validation
➢ Types of Validation
➢ Types of Qualification
 Validation

 Action of proving, in accordance with the principles of

GMP, that any procedure, process, equipment, material,
activity or system actually leads to the expected results
(WHO TRS986 – 2014)
 Validation is an integral part of Quality Assurance , it
involves the systematic study of systems, facilities and
processes aimed at determining whether they perform their
intended functions adequate and consistently as specified.
 Validation

 A validated process is one which has been demonstrated to

provide a high degree of assurance that uniform batches will
be produced that meet the required specifications and has
therefore been formally approved.

 Validation itself doesn't improve processes but confirms that

the processes have been properly developed and are under
control.
 Validation

 According to ISO :
“Validation is the confirmation by examination and the
provision of objective evidence that the particular requirements
for a specific intended use are fulfilled”
 According to FDA
“Establish documented evidence which provides a high degree
of assurance that specific progress will consistently produce a
product meeting its predetermined specifications and quality
attributes”.
 Calibration

 The set of operations that establish, under specified

conditions, the relationship between values indicated by an
instrument or system for measuring (especially weighing),
recording, and controlling, or the values represented by a
material measure and the corresponding known values of a
reference standard. Limits for acceptance of the results of
measuring should be Established.
(WHO TRS986 – 2014)
 Calibration of an instrument is the process of determining its
accuracy.
 Calibration

 Calibration involves obtaining a reading from the instrument

and measuring its variation from the reading obtained from a
standard instrument.

 Calibration achieves 2 main objectives:

1- It checks the accuracy of an instrument.
2- It determines the traceability of the measurement.
 Calibration

 Balances and other measuring equipment of an appropriate

range and precision should be available for production and
control operations and should be calibrated according to a
fixed schedule.
(WHO TRS986 – 2014)
Verification
Ensure the correct operation of equipment or a process
according to its stated operating specification
 Verification is a calibration but in small scale or short
intervals.
 Qualification

 Action of proving that any premises, systems and items of

equipment work correctly and actually lead to the expected
results. The meaning of the word “validation” is sometimes
extended to incorporate the concept of qualification.

 It is the action of proving and documenting that equipment

or ancillary systems are properly installed, work correctly,
and actually lead to the expected results.

 Qualification is part of validation, but the individual

qualification steps alone don’t constitute process validation.
 Why do we Validate?

1- Assure Quality.
2- Time bound.
3- Process Optimization.
4-Reduction in rejection.
5-Minimal batch failures, improved efficiently and
productivity.
 Why do we Validate?

6- Reduction of quality cost.

7-Increased output.
8- Reduced testing in process and in finished
products.
9- Governmental regulations (Compliance with
validation requirements is necessary for obtaining
approval to manufacture and to introduce new
products).
Which items we should
Validate?

Process
validation

Validation

Cleaning
validation
 Types of validation

1-Prospective
4-Revalidation
validation

Validation
3-Concurrent 2-Retrospective
validation validation
 What is the purpose of
Qualification?
 A qualification serves to prove that
equipment is fit for purpose.
 “fit for purpose” means that:
 the equipment meets the proscribed
requirements.
 the equipment meets the requirements in a
reproducible manner.
 Qualification

 Every pharmaceutical manufacturer is

responsible to qualify its quality relevant
equipment and facility, i.e. rooms, production
equipment, machines and utility systems.
 Qualification

 Design Qualification .
 Installation Qualification.
 Operation Qualification .
 Performance Qualification.
 Qualification

DQ

PQ Qualification IQ

OQ
Validation v/s Qualification
Validation v/s Calibration
 Discussion

Thank you for your

attention!!!!