MODEL VALIDATION:
Validation is a documented evidence to demonstrate that all the processes, system, utility or
facility are designed is such a way that they produce the same result on repeated usage.
PRINCIPLES OF VALIDATION:
The execution of validation should be in compliance with regulatory expectations
Quality, safety and efficacy must be designed and build into the product
Quality cannot be inspected or tested into the product
Quality risk management principles should be applied in determining the need, scope
and extent of validation
Ongoing review should take place to ensure that the validated state maintained and
opportunities for continuing improvement are identified.
IMPORTANCE OF VALIDATION:
Validation ensures the product quality.
Reduces the changes of non-compliance.
Reduces the changes of product recall.
Data of validation acts as proof in making decisions.
Meet regulatory requirements.
During inspection validation data gives assurance to the inspecting bodies that the
procedures are reliable.
Cost of manufacturing is reduced due to less testing because once the product is
validated we do not require intensive testing on all the stages.
TYPES OF VALIDATION:
There are following types of validation.
1) Process validation
2) Cleaning validation
3) Method validation
4) Computer validation
1)PROCESS VALIDATION:
It is an establishment of documented evidence which provides a high degree of
assurance that a specific process will consistently produce a product meeting its predetermined
specifications and quality characteristics.
Stages of activities in process validation:
Process Design: The commercial manufacturing process is defined during this stage
based on knowledge gained through development and scale-up activities.
Process Qualification: During this stage, the process design is evaluated to determine if
the process is capable of reproducible commercial manufacturing.
Continued Process Verification: Ongoing assurance is gained during routine
production that the process remains in a state control.
TYPES OF PROCESS VALIDATION:
1. Prospective Validation
2. Concurrent Validation
3. Retrospective Validation
4. Revalidation
1. Prospective Validation is establishment of documented evidence of what a system does
or what it purports to do based upon a plan. This validation is conducted prior to the
distribution of new product.
2. Concurrent Validation is establishment od documented evidence of what a system does
or what it purports to do information generated during implemented of the system.
3. Retrospective Validation is the establishment of documented evidence of what a system
does or what it purports to do based upon the review and analysis of the existing
information. This is conducted in a product already distributed based on accumulated
data of productions, testing and control.
4. Revalidation: Whenever there are changes in packaging, formulation, equipment or
processes which could have impact on product effectiveness or product effectiveness or
product characteristics, there should be revalidation of the validated process.