1. Presented by
Ujjwal Mandal
1st year,1st sem
M.pharm(Pharmaceutics
)
INTRODUCTION,TYPES,
SCOPES & NEEDS OF
VALIDATION

2. CONTENTS
 INTRODUCTION
 TYPES OF VALIDATION
 Process Validation
 Cleaning Validation
 Equipment Validation
 Validation of Analytical method
 SCOPES OF VALIDATION
 NEEDS OF VALIDATION
 VALIDATION MASTER PLAN(VMP)
 CONCLUSION
 REFERENCE

3. Introduction
 The concept of validation was first proposed
by Food
and Drug Administration (FDA) officials, in1979s
in(USA).
 Definition : Validation is a written
documented process for establishing
documentary evidence demonstrating a
procedure, process, or activity of a
pharmaceutical product.

4. TYPES OF VALIDATION
The major types of Validation :
 1. Process Validation
 2. Cleaning validation
 3. Equipment validation
 4. Validation of analytical methods

5. o 1. Process Validation : In process validation,
the collection of data from the process design
stage throughout production, which setup a report.
o Its are four types.
 Prospective validation.
 Retrospective validation.
 Concurrent validation.
 Revalidation.

6. o 2. Cleaning Validation:
Cleaning validation is the methodology used to
assure that a cleaning process removes residues of
the active pharmaceutical ingredients(API) of the
product manufactured from the equipment.
 The U.S. Food and Drug Adminstration (FDA)
has strict regulation about the cleaning validation.

7. o3. Equipment Validation:
Equipment validation is done for any
equipment works correctly or checked that it may
leads to the expected result as pre-determined.
 It is not a single step activity.
o 4. Validation of analytical methods:
In product manufacture have various analytical
methods, which are to be validated for get good
assurence of product.

8. SCOPES OF VALIDATION
 Involvement of management and quality
assurance.
 A written report outcome.
 Significant changes (facilities, equipment,
processes) -should be validated.
 Validation should be performed:–for new
premises, equipment, utilities and systems, and
procedures ,when major changes have been
made on it.

9. NEEDS OF VALIDATION:
 Decrease the risk of manufacturing.
 Assures the fluency of production.
 During the process the knowledge of process
increases.
 Control production cost.
 Reduces the chances of product recall from the
market.
 Make process better understood.
 Increases patients compliance.

10. VALIDATION MASTER PLAN
(VMP):
 The validation master plan (VMP) should reflect
the key elements of the validation program. It
should be concise and clear contain of the
following……
• a validation policy.
• Planning and scheduling.
• Documents format use for validation.
• Change in control.
• Reference to existing documents.

11. CONCLUSION
At the conclusion of validation activities, a
final report should be prepared. This report
should summarize and reference all protocols
and results of a process.
By validation report, we can produce a product
at pre-determined level of quality.

12. REFERENCES
 Robert A. Nash, Alfred H. Watcher,
Pharmaceutical Process Validation, An
international Third Edition, Revised and
Expanded, vol-129
 P.P. Sharma ,Validation In Pharmaceutical
Industry, Second Edition , Vandana publications.
 Ramesh Sawant and Sandip Hapse,
Fundamental of quality assurance techniques,
First edition Dec 2011, Career publications.