What are the key benefits of validation?

Key benefits involve but are not limited to:

Importance of Validation
Increased throughput
Reduction in rejections and reworking
Reduction in utility costs
Avoidance of capital expenditures
Fewer complaints about process-related failures
Reduced testing in-process and in finished goods
More rapid and reliable start-up of new equipment
Easier scale-up from development work
Easier maintenance of equipment
Improved employee awareness of processes
More rapid automation

Definitions of Validation
Action of proving, in accordance with the principles of good manufacturing practice, that
any procedure, process, equipment, material, activity, or system, leads to the expected
result
Documented evidence which provides a high degree of assurance that a specific process
will consistently produce a product meeting its predetermined specifications and quality
attributes and characteristics
 Obtaining and documenting evidence to demonstrate that a method can be relied upon to
produce the intended result within defined limits
Action to verify that any process, procedure, activity, material, system, or equipment used
in manufacture or control can, will, and does achieve the desired and intended results

Justification of Validation
Validation is basically good business practice. The objective is to achieve success
in the first production of a new product.
Government regulations
Current good manufacturing practices (GMPs) have been established all over the world. The
GMPs basically serve as guidelines but do not provide step-by-step directions on how to
achieve them. However, the validation master plan and associated SOPs exactly define
responsibilities: who, when, where, and how much is sufficient to demonstrate.
Assurance of quality
Validation provides confidence in the quality of products manufactured as the over quality
of a particular process cannot be established due to the limited sample size. Validation leads
to less troubleshooting within routine production. As a result, it reduces the number of
customer complaints and drug recalls.
Cost reduction
Processes running at marginal levels often cause costs because of necessary reinspection,
retesting, rework, and rejection. Validation leads to the optimization of processes and
results in minimization of those expenses.

Validation Policy
Below principles should apply for validation:
 The execution of validation should be in compliance with regulatory requirements.
 Validation should reinforce GMP.
 Quality risk management principles should be applied in determining the need,
scope and extent of validation.
 Ongoing review should take place to ensure that the validated state is maintained
and opportunities for continuous improvement is identified
 Time, personnel and financial requirements should be ensured for validation.
Validation master plan content
Content may include the following descriptions (but not be limited to):
1. Introduction
1.1 Project Description
1.2 What a Validation Master Plan Is
1.3 Scope of Validation Master Plan
1.4 Definition for the Term Validation
1.5 Validation Team Member
1.6 Validation Team Responsibility
2. Concept of Qualification or Validation
 2.1 Fundamentals
2.2 Concept of a Validation Life Cycle
2.3 Elements of Validation
2.4 Documentation Format of Qualification Programs
2.5 Numbering System
3. Revalidation
4. Facility Description
5. Description of Building
5.1 Dry Production Facility
5.2 Liquid and Semi-Solid Production Facility
5.3 Parenteral Production Facility
6. Equipment Description
6.1 Dry Production
6.2 Liquid and Semi-Solid Production
6.3 Parenterals Production
6.4 Overprinting Area
6.5 Quality Control
6.6 Quality Assurance (In-Process)
6.7 Product Development Laboratories
7. HVAC Description
7.1 Dry Production Facility
7.2 Liquid and Semi-Solid Production Facility
7.3 Parenterals Production Facility
7.4 Overprinting Area
7.5 Quality Control
7.6 Quality Assurance (In-Process)
7.7 Product Development Laboratories
8. Utilities Description
9. Validation Program Overview
9.1 Validation Project Management
9.2 Validation Responsibilities
9.3 Design and Validability Review
9.4 Validation Documents
9.5 Installation Qualification Protocols
9.6 Operational Qualification Protocols
9.7 Change Control Initiation
9.8 Cycle Development
9.9 Performance Qualification Protocols
9.10 Process Validation Protocols
9.11 Validation Final Reports
9.12 Validation Package
9.13 Certificate for Use in Manufacturing
9.14 Required Protocols and Procedures for Dry Production
9.15 Required Protocols and Procedures for Liquid and Semisolid Protocols
9.16 Required Protocols and Procedures for Parenterals Production
10. Calibration Program Summary
11. Preventive Maintenance Program Summary
12. Key SOPs
13. Validation of Building Test Functions and Acceptance Criteria
13.1 Civil Work
13.2 Drainage System
14. Validation of Utility Systems, Test Functions, and Acceptance Criteria
14.1 Plant Steam
14.2 Pure Steam
14.3 Water for Injection
14.4 Compressed Air
14.5 Nitrogen (N2)
14.6 Carbon Dioxide (CO2)
14.7 Heating Ventilation and Air Conditioning (HVAC)
14.8 Emergency Power
15. Process Description Dry Products
15.1 Process Flow, Variables, and Responses: Tablets
15.2 Process Flow, Variables, and Responses: Powder for Suspension
15.3 Process Flow, Variables, and Responses: Capsules
16. Process Description Liquids and Semi Solid Products
16.1 Process Flow, Variables, and Responses Syrups, Suspension, and Drops Products
16.2 Process Flow, Variables, and Responses Cream, Ointment, and Suppository
Products
17. Process Description Parenterals Product
17.1 Process Flow, Variables, and Responses Aseptic Fill Products
17.2 Process Flow, Variables, and Responses Aseptic Fill Ready-to-Use Disposable
Syringes
17.3 Process Flow, Variables, and Responses Terminal Sterilization Products
17.4 Process Flow, Variables, and Responses Lyophilized Products
18. Qualification of Process Equipment Test Functions and Acceptance Criteria
18.1 Commuting Mull
18.2 Oven
18.3 V-Shell Blender
18.4 Tablet Compression
18.5 Capsulation
18.6 Powder Filling
18.7 Capsule Polisher
18.8 Tablet Coating
18.9 Syrup Manufacturing Vessel
18.10 Suspension Manufacturing Vessel
18.11 Drops Manufacturing Vessel
18.12 Mixer
18.13 Emulsifying Mixer
18.14 Filter Press
18.15 Cream, Ointment, and Suppository Manufacturing Vessel
18.16 Syrup, Suspension, and Drop Filling Machine
18.17 Cream and Ointment Filling Machine
18.18 Suppository Filling Machine
18.19 Labeling Machine
 18.20 Capping Machine
18.21 Cartonator
18.22 Shrink Wrapping Machine
18.23 Overprinting Machine
18.24 Trays and Rack Washer
18.25 Autoclave (Steam Sterilizer)
18.26 Hot Air Tunnel (Dry Heat Sterilizer)
18.27 Vial and Ampule Washing Machine
18.28 Vial, Ampoule, and Syringe Filling Machine
18.29 Freeze Dryer (Lyophilizer)
18.30 Laminar Flow Unit
18.31 Pass Through
19. Validation of Support Processes Test Functions and Acceptance Criteria
19.1 Washing of Components
19.2 Sterilization of Components
19.3 Depyrogenation of Components
19.4 Aseptic Filling Validation (Media Fill Studies)
19.5 Cross-Contamination Control
19.6 Computerized Pharmaceutical System
20. Quality Assurance/Control Laboratory Validation
20.1 Laboratory Equipment Qualification
20.2 Computer-Related Systems in QA and QC
21. cGMP Procedures and Programs
21.1 Engineering Change Control
21.2 Calibration
21.3 Preventive Maintenance Program
21.4 Standard Operating Procedure (SOP)
21.5 Facility Cleaning and Sanitization
21.6 Environmental Monitoring Program
21.7 HEPA Filter Integrity Testing
21.8 Filter Integrity Testing
21.9 Label Control Program
21.10 cGMP Training
21.11 Equipment Log Book, Status Tags, and Room Clearance
21.12 Validation Files
22. Validation Schedule
23. Drawings and Layouts
23.1 Dry Production Facility
23.2 Liquid and Semisolid Production Facility
23.3 Parenterals Production Facility
23.4 Deionized Water System
23.5 HVAC
23.6 Water for Injection
23.7 Steam Distribution
23.8 Compressed Air Distribution
23.9 Nitrogen Distribution
23.10 Drainage System
 23.11 Personnel Flow
23.12 Materials Flow
23.13 Electrical Drawings
23.14 Equipment Installation Drawings
Equipment and utility:
 Facility is having below mentioned key equipment and utility:
 Rapid mixing granulator
 Fluid bed dryer
 Compression machine
 Blister packing machine
 Manufacturing vessel
 Liquid filling machine
 Double door autoclave
 Tunnel sterilizer
 Dry heat sterilizer
 Laminar air 􀃙ow
 Auto-cartonator
 Water system
 Pure steam generator
 HVAC
 Boiler
Process:
 Manufacturing process is divided in below steps:
 Dispensing
 Mixing
 Filling
 Packaging
 Testing
 Release