This document discusses process validation. It begins by defining validation as proving that a process leads to expected results and quality products. It notes that validation is needed for new methods, changes to established methods, out of control situations, and comparing methods. The advantages of validation include quality assurance through consistent quality production and process optimization. There are several types of validation: prospective uses pre-planned protocols, retrospective reviews historic data, concurrent involves monitoring, and revalidation ensures changes don't affect quality. In conclusion, validation ensures quality products, equipment qualification, and process optimization and cost reduction.

1. Presented By :
RONIT GHOSH
ROLL NO : 18901914082
REG NO. : 141890210082
4th Year 7th Semester Section- B
Guided By :
Dr. SUBHRA BHATTACHARYYA
(Associate Professor)
Dr. B.C. Roy College Of Pharmacy And Allied Health Sciences, Durgapur -713206
PROCESS VALIDATION

2. CONTENTS
Ø Introduction
Ø Need of Validation
Ø Where Validation is required
Ø Advantages of Validation
Ø Process Validation and its activities
Ø Types of Process Validation :
v Prospective Validation
v Retrospective Validation
v Concurrent Validation
v Revalidation
Ø Conclusion
Ø References 2

3. ü Validation is the action of proving that any process,
equipment, method or activities actually leads to the expected
results and produce a quality products.
q Need of Validation:
v To obtain accurate data.
v Helps in decision making.
v To get assurance of Quality product.
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INTRODUCTION

4. WHERE VALIDATION IS REQUIRED
v New method development for a particular problem.
v Changes in established method.
v Certain out of control situation.
v Comparison of two methods.
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5. q Advantages of Validation :
ü Quality assurance:-
v It is not possible to control a process properly without
thorough knowledge of the capabilities of that process.
v Without validated and controlled processes, it is impossible
to produce quality products consistently.
ü Process optimization :
v Validation helps to optimize the process for its maximum
efficiency with maintaining its quality standards.
v The optimization of the facility, equipment, systems, and
processes results in a product that meets quality requirements
at the lowest cost.
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6. ü Quality cost reduction:
v Any validated and controlled process will result in fewer
internal failures like :-
i. Fewer rejects
ii. Reworks
iii. Re-tests
iv. Re-inspection
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7. ▸ It is defined as the collection and evaluation of data which provides
an assurance that a process will consistently produce a quality
product.
PROCESS VALIDATION ACTIVITIES
v Process validation involves a series of activities taking place over the
lifecycle of the product and process.
v Process validation activities follows three stages :
• Stage I: Process Design
• Stage II: Process qualification
• Stage III: Continued process verification
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PROCESS VALIDATION

8. q Stage I – Process Design:
The commercial manufacturing process is defined during this stage
based on knowledge gained through development and scale-up activities.
q Stage II – Process Qualification:
During this stage, the process design is evaluated to determine
whether the process is capable to produce reproducible results or not.
q Stage III – Continued Process Verification:
On-going assurance is done during routine production, So that the
process remains in a state of control.
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9. TYPES OF PROCESS VALIDATION
v Prospective Validation
v Retrospective Validation
v Concurrent Validation
v Revalidation
ü Prospective Validation :
It is establishing documented evidence prior to process
implementation that a system does what it proposed to do based on
pre-planned protocols.
It is normally undertaken for a new drug product, which are
introduced into a routine pharmaceutical production.
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10. ü Retrospective Validation :
It is an establishing documented evidence that a process does
what it is supposed to do based on review and analysis of
historic data.
v Steps require for Retrospective Validation :
• Protocol preparation
• Validation reports
• Data analysis
• Conclusion
• Recommendations
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11. ü Concurrent Validation :
Is a type of evidence that can be gathered to defend the use of
a test for predicting other outcomes.
q Concurrent Validation involves –
v In-process monitoring
v End product testing
ü Revalidation :
It provides the evidence that changes in a process introduced
either intentionally or unintentionally, do not affect product
quality.
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12. q There are two basic categories of Revalidation:
v Re-validation in cases of known change.
v Periodic Re-validation carried out at scheduled
Intervals.
q Changes that are likely to require Revalidation are as
follows:
v Changes of raw materials.
v Change of starting material
v Changes of packaging material
v Changes in the process
v Changes of equipment
v Transfer of processes to another site
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13. CONCLUSION
ü Validation provides the good quality product and equipment.
ü Validation gives the surety about the equipment qualification like:
design, operation, installation and performance.
ü Validation of equipment can able to produce satisfactory results.
ü Validation also helps in process optimization and cost reduction.
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14. REFERENCES
v Rockville M D. guideline on General principle of process validation.
U.S Food and Drug Administration., U.S, FDA:1987
v Rockville M D. guideline on General principle of process validation.
U.S Food and Drug Administration., U.S, FDA:2010
v Lamberts J. Validation guidelines for the pharmaceuticals Dosage
forms. Health Products and Food Branches inspectorates,2004,7-15
v Tatzlaff R F, Shepperd RE, LeBianc A.J. The validation development.
Perspectives on the systemic GMP inspection approach and validation
development. Pharm Tec.,1993,100-116
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