This document discusses validation in the pharmaceutical industry. It defines validation and explains why it is important. Validation ensures a process will consistently produce products meeting requirements. The document outlines the scope of validation, including analytical methods, equipment, and facilities. It also describes a validation master plan, which provides documentation for qualification and process validation. Validation has advantages like reduced costs, assured quality, and process optimization.

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MODERN PHARMACEUTICS
VALIDATION
RR COLLEGE OF PHARMACY
Submitted to:
Mrs Sujatha P M
Associate professor
Department of pharmaceutics
Submitted by:
SUPRITH D
1st sem. M.Pharm.
Department of pharmaceutics

2. CONTENTS
1) INTRODUCTION
2) WHY VALIDATION IS NEEDED
3) SCOPE OF VALIDATION
4) IMPORTANCE OF VALIDATION
5) VALIDATION MASTER PLAN
6) ADVANTAGES
7) REFERENCES
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3. INTRODUCTION
Validation is defined as “A Documented Programme , which provides a high degree of
assurance that a specific process will consistently produce a product meeting its pre-
determined specifications and quality attributes”.
Validation is the process of evaluating products or analytical methods to ensure compliance
with products or cleaning method requirements
AS PER WHO
Validation means providing documented
evidence that any procedure, process,
activity or system actually leads to the
expected results.
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4. WHY VALIDATION IS DONE ?
It would not be feasible to use the equipments without knowing whether
it will produce the product we wanted or not.
The pharmaceutical industry uses expensive materials, sophisticated
facilities & equipments and highly qualified personnel.
The efficient use of these resources is necessary for the continued
success of the industry.
The cost of product failures, rejects, reworks, recalls, complaints are the
significant parts of the total production cost.
Detailed study and control of the manufacturing process- validation is
necessary if failure cost is to be reduced and productivity improved.
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5. SCOPE OF VALIDATION
Analytical
Instrument Calibration
Raw materials
Packaging materials
Equipment
Facilities
Cleaning
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6. IMPORTANCE OF VALIDATION
 Reduction of quality costs
 Process optimization
 Assurance of quality
 Safety
 Increased output
 More rapid automation
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VALIDATION MASTER PLAN (VMP)
The VMP serves as the validation roadmap setting the course, justifying the strategy, outlining
the preliminary test and acceptance criteria, and documenting the necessary programs that ensure
a continuing state of validation.

8. Typical VMP Contents
1. Introduction
2. Scope
3. Facility Description
4. Commissioning
5. Qualification
6. Process Validation
7. Computer System Validation
8. List of Required Protocols and Procedures
9. List of Required Standard Operating Procedures
10. Equipment and Utility System Descriptions
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9. 1. Introduction
 This should include the company name, location, division or subsidiary name (if applicable) and business
sector served.
 A short overview of the project provides the reader with the necessary background from a macro standpoint.
A cross reference to the relevant company Quality Assurance Policy is appropriate here.
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10. 2. Scope
 This defines the breadth and reach of the validation effort covered by the
VMP
 A brief description of the installation, whether single- or multi-product, and
a breakdown of installed equipment as new or existing should be included
here.
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11. 3. Facility Description
 Whether the project is in a new building, extension, or remodeling of a current building, the facility
characteristics are listed here
 The number of floors, the inter-connectivity of process and utility systems, isolation means, and the design
product
 Personnel flow used to minimize cross-contamination are identified.
 Any room classification (cleanroom certification levels) and specialty surfaces and finishes integral to
achieving the required product quality.
 Useful in Process Flow Diagrams (PFDs), depicting the anticipated personnel, raw material, process, and
waste material flow.
 To eliminate cross contamination of material.
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12. 4. Commissioning
 Document here the selection criteria governing what equipment and utility systems will undergo
Commissioning.
 As Commissioning is not part of the Validation Program and is not regulated by the FDA, people often wonder
why they should include this section at all.
 It justifies about identifying support utilities that do not need to be validated because they do not directly affect
product quality.
 It also demonstrates thoroughness, showing the FDA that all systems have been examined for product quality
impact. To maximize the usefulness of commissioning, the system should be tested within the anticipated
operating range of the respective OQ
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13. 5. Qualification
 The selection criteria governing what equipment and utility systems will undergo Qualification is discussed
here.
 Individual definitions of IQ, OQ, and PQ, may be included. Company policies, regulatory references, and
published guidelines used in this selection process should be addressed.
 This discussion may include considerations such as product contacting surfaces, critical/non-critical
instrumentation, direct and indirect systems and downstream processing, among others.
 A discussion of protocol and final report formats may be included here, with either a reference to existing
protocol development procedures, or a description of the format to be utilized.
 Final Reports may be generated as attachments to the protocols themselves, or as separate documents
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14. 6. Process Validation
 This section addresses the selection criteria governing what equipment and utility systems need to undergo
Process validation.
 Company policies, regulatory references, and published guidelines utilized in the selection process should be
addressed.
 If this is to be a finished product, Packaging and Sterility validation needs to be addressed.
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15. 7. Computer System Validation
 A separate section should be devoted to the discussion of Computer Validation, whether that is in the form of
a Programable Logic Controller (PLC) or a Distributed Control System (DCS).
 Computer Validation criteria also should be discussed, and whether the installed control system is to be 21
CFR 11 compliant, i.e., secure audit trails, authority checks,etc.
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16. 8. List of Required Protocols and Procedures
 It Includes a tabular representation of the equipment and utility systems, and the required protocols and
procedures associated with each
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18. 9. List of Required Standard Operating Procedures (SOPs)
 This will help identify the level of SOP generation necessary to complete
validation activities.
 It will generally take the form of Operation, Maintenance, and Cleaning SOPs.
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19. 10. Equipment and Utility System Descriptions
 An overview of the particular system should be given, aligned with the Basis of Design documentation.
 A listing of proposed Qualification tests (IQ/OQ/PQ) should be identified with a brief description of the
procedure and how the associated Acceptance Criteria will be determined.
 As the VMP should be developed early in the planning stage, many system specifics will be in the draft phase
and subject to change.
 To avoid duplication of effort and unnecessary revisions, do not assign numeric-specific acceptance Criteria in
the VMP. Those details will be fully delineated in the respective Qualification
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21. ADVANTAGES
 Consistent through output.
 Reduction in rejections and reworks.
 Avoidance of capital expenditures.
 Fewer complaints about process relatedfailure.
 More rapid and accurate investigations intoprocess deviation.
 More rapid and reliable start-up of newequipment.
 Easier scale-up from development work.
 Easier maintenance of equipment.
 Improve employee awareness of processes.
 More rapid automation.
 Assurance of quality
 Process optimization.
 Reduction of quality cost.
 Reduced testing in process and in finished goods 30-04-2022
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22. REFERENCE
 The Official Journal of ISPE PHARMACEUTICAL ENGINEERING® May/June, 2001 Vol. 21 No. 3
 U.S. Food and Drug Administration, Manual of Standard Operating Procedures and Policies, Communication, SOPP 8101.1,
Version 1, Effectivity date February 11, 1999
 Federal Food, Drug and Cosmetic Act, Chapter III, Sections 301, 303, 304, as amended by the FDA Modernization Act of
1997
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