2. Contents
1) Introduction
2) Definitions
3) The field of validation
4) Reason for validation
5) Functions of different departments
6) Scope of validation
7) Merits of validation
8) Reference
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3. Introduction
The concept of validation was first proposed by two Food and
Drug Administration (FDA) officials, Ted Byers and Bud Loftus, In
1979 in USA, to improve the quality of pharmaceuticals. And later
on it became an important part of current good manufacturing
practices.
Validation is an integral part of quality assurance; it involves the
systemic study of systems, facilities and processes aimed at
determining whether they perform their intended functions
adequately and consistently as specified.
Validation in itself does not improve processes but confirms that
the process have been properly developed and are under control.
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4. Definitions:
• According to the US Food and Drug Administration (FDA), the goal of
validation is to:
“Establish documented evidence which provides a higher degree of
assurance that a specific process will consistently produce a product
meeting its predetermined specifications and quality attributes.”
• 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.”
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5. • According to European Commission:
“Action providing in accordance with the principles of GMP, that
any procedure, process, equipment, material, activity or system
actually lead to the expected results”.
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6. Validation should thus be considered in the
following situations:
• Totally new process;
• New equipment;
• Process and equipment which have been altered to suit changing
priorities; and
• Process where the end-product test is poor and an unreliable
indicator of product quality.
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7. The field of validation
1. Equipment validation
2. Facilities validation
3. HVAC System validation
4. Cleaning validation
5. Process validation
6. Analytical method validation
7. Computer system validation (CSV)
8. Packaging validation
9. Cold chain validation
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8. Reason For Validation
1) It is regulated requirement stipulated in cGMP
2) Greater impart on product development process
3) Cost reduction
4) To produce zero defect product
5) End result of validation will be higher quality more
uniform and reproducible product
6) Makes a good business source ,decrease batch reject
& retails
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9. Functions of different department
Validation is a team effort.
Validation
Team
QA
QC
R & DManufacturing
ENGINEERING
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10. Engineering Install, quality & certify plant facility, equipment and support
system
R & D Design, optimize, quality manufacturing process with limits &
specifications
Manufacturing Operate & maintain plant facilities, equipment support system
process and strictly follow SOP
QC Follow the validation protocol develop by QA & validate the
incoming stock in process critical system & final product
QA Establish approvable validation protocols & conduct process
validation by monitoring, sampling, challenging the process and
equipment
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11. Classification of validation
1) Analytical validation
2) Process validation
3) Qualification validation
4) Cleaning validation
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12. Scope of validation
Validation requires an appropriate & sufficient
infrastructure including:
Organization, Documentation, Personnel and Finances
Involvement of management and quality assurance
personnel
Personnel with appropriate qualifications and
experience
Extensive preparation & planning before validation is
performed
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13. Continue…
Validation done in a structured way according to
documentation including procedures and protocols
Validation should be performed:
For new premises, equipment, utilities system and processes
and procedures
At periodic intervals; and
When major changes have been made.
Validation is accordance with written protocols.
Manufactures to identify what validation work is
needed
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14. Merits of validation
During the process the knowledge of process increases
Assures the repeatability of the process
Assures the fluency of production
Assures that the product is continuously according to
the marketing authorization
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15. Continue…
Decreases the risk of manufacturing problems
Decreases the expenses caused by the failure in
production
Decreases the risk of failing in GMP
Decreases the expenses of the every day production
even through the validation itself will create expenses
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16. Reference
Industrial pharmacy, A Comprehensive approach, by D.K
Tripathi,(671-699)
Pharmaceutical process validation: An Overview, by M.d Shoaib Alam
etal ; Journal of advanced pharmacy education & research, Oct-Dec
2012, vol 2, issue 4, (190-196)
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