This document discusses the introduction, types, scopes, and needs of validation in the pharmaceutical industry. The major types of validation covered are process validation, cleaning validation, equipment validation, and validation of analytical methods. Process validation involves collecting data from design through production to establish a report. Cleaning validation ensures cleaning processes remove active pharmaceutical ingredients from equipment. Equipment validation checks that equipment works correctly. Validation of analytical methods assures methods used to test products are good. Validation is needed to decrease risks, assure production quality, control costs, and reduce recalls. A validation master plan outlines the validation program and policy.

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.