AREAS COVERED : validation , advantages , process validation , types

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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