Introduction and scope of validation

1. Presented by,
Jahnabi Sarmah
Dept. of pharmacy
M. Pharm 1st sem
INTRODUCTION AND SCOPE
OF VALIDATION
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Guided by,
Dr. Ananta Choudhuri
Associate professor
Dept. of pharmacy

2. CONTENT:
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• Introduction
• Need for validation
• Types of validation:
 Prospective validation (or premarket validation)
 Retrospective validation
 Concurrent validation
 Revalidation
• Scope of validation
• Reference

3. INTRODUCTION:
• The concept of validation was first proposed by two Food
and Drug Administration (FDA) officials.
• Byers and Bud Loftus, in the mid 1979s in(USA )order to
improve the quality of pharmaceuticals. It was proposed in
direct response to several problems in the sterility of large
volume parenteral market.
• The first validation activities were focused on the
processes involved in making these products, but quickly
spread to associated processes including environmental
control, media fill, equipment sanitization and purified
water production.
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4. INTRODUCTION:
• Validation is the process of establishing documentary
evidence demonstrating that a procedure, process, or
activity carried out in testing and then production
maintains the desired level of compliance at all stages.
• In the pharmaceutical industry, it is very important that in
addition to final testing and compliance of products, it is
also assured that the process will consistently produce the
expected results.
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5. INTRODUCTION:
There are 3 key points to from this definition:
• The evidence must be documented.
• Valiodation applies to several aspects of manufacturing,
including process development, materials, personal and
equipment.
• It should demonstrate that the system does what is
expoected of it.
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6. NEED FOR VALIDATION:
• Customer satisfaction
• Customer mandated.
• Product liability.
• Control production cost
• Development of new generation.
• Safety.
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7. TYPES OF PROCESS VALIDATION:
The guidelines on general principles of process validation
mentions four types of validation:
A) Prospective validation (or premarket validation)
B) Retrospective validation
C) Concurrent validation
D) Revalidation
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8. PROSPECTIVE VALIDATION:
• This is performed for all new equipment, product and
processes.
• It is a proactive approach of documenting of design,
specification and performance before the system is
operational.
• This is the most defendable type of validation.
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9. RETROSPECTIVE VALIDATION:
• Retrospective validation is used for facilities, processes,
and process controls in operation use that have not
undergone a formally documented validation process.
• Validation of these facilities, processes, and process
controls is possible using historical data to provide the
necessary documentary evidence.
• Therefore, this type of validation is only acceptable for
well-established processes and will be inappropriate where
there have been recent changes in the composition of
product, operating processes, or equipment.
• This approach is rarely been used today because it’s very
unlikely that any existing product hasn’t been subjected to
the Prospective validation process. It is used only for the
audit of a validated process. 9

10. CONCURRENT VALIDATION:
• Concurrent validation is used for establishing documented
evidence that a facility and processes do what they purport
to do, based on information generated during actual
imputation of the process.
• This approach involves monitoring of critical processing
steps and end product testing of current production, to
show that the manufacturing process is in a state of
control.
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11. REVALIDATION:
• Revalidation means repeating the original validation effort
or any part of it, and includes investigative review of
existing performance data. This approach is essential to
maintain the validated status of the plant, equipment,
manufacturing processes and computer systems. Possible
reasons for starting the revalidation process include:
• The transfer of a product from one plant to another.
• Changes to the product, the plant, the manufacturing
process, the cleaning process, or other changes that could
affect product quality.
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12. REVALIDATION:
• The necessity of periodic checking of the validation
results.
• Significant (usually order of magnitude) increase or
decrease in batch size.
• Sequential batches that fail to meet product and process
specifications.
• The scope of revalidation procedures depends on the
extent of the changes and the effect upon the product.
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13. SCOPE OF VALIDATION:
• Validation requires an appropriate and sufficient
infrastructure including:–organization, documentation,
personnel and finances.
• Involvement of management and quality assurance
personnel
• Personnel with appropriate qualifications and experience
• Extensive preparation and planning before validation is
performed.
• A specific programme for validation activities in place.
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14. SCOPE OF VALIDATION:
• Validation done in a structured way according to
documentation including procedures and protocols.
• Validation should be performed:–for new premises,
equipment, utilities and systems, and processes and
procedures;–at periodic intervals; and–when major
changes have been made.
• Validation in accordance with written protocols.
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15. SCOPE OF VALIDATION:
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• A written report on the outcome to be produced.
• Validation over a period of time, e.g.–at least three
consecutive batches (full production scale) to demonstrate
consistency.
• Process, materials and equipment to prove consistent yield
of a product of the required quality.
• Manufacturers to identify what validation work is needed
• Significant changes (facilities, equipment, processes) -
should be validated
• •Risk assessment approach used to determine the scope
and extent of validation needed.

16. REFERENCE:
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• Fundamental of quality assurance techniques…by Ramesh
Sawant and Sandip Hapse, First edition Dec 2011, Career
publications.
• Pharmaceutical Quality Assurance...by Manohar Potdar,
Second edition Dec 2007,Nirali Prakashan.
• IJRPC 2011` An overview of pharmaceutical validation:
quality assurance view point’ by Nandhakumar et al.
• IJPR Review Article’ An Overview of pharmaceutical
Validation and Process Controls in Drug Development’
Elsie Jatto and Augustine O. Okhamafe.

17. SCOPE:
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