DINESH KUMAR Mankaran Singh Deepak Sharma Gurmeet Singh M.

PHARMACY PHARMACEUTICS CT Institute of Pharmaceutical sciences Jalandhar, INDIA AICTE , PCI approved

VALIDATION
It is established documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting it predetermined specifications and quality characteristics. Prevention based activity Proactive tool of Quality assurance activity

The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing through out the production phase.

OBJECTIVE
To review risk analysis and critical steps of processing for achievement of Quality, safety and effectiveness in the ultimate formulation.
The purpose of validation of any material, equipment or process is achieved by means of a

validation protocol
Tests to be carried out Frequency of testing

Results expected
Acceptance criteria

The validation of facilities, equipment and services is called Qualification Stage of Validation Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)

VALIDATION PLAN
Design Qualification (DQ)
User requirement specification Functional specification Operational specification Vendor Qualification Check arrival as purchased Check hardware as well as software

Installation Qualification (IQ)

Operational Qualification (OQ)

Test of key operational functions Test of security functions

Performance Qualification (PQ)

Test for specified application Preventive maintenance On-going Performance tests

TYPES OF VALIDATION
Prospective
Documented before the process is operational Pre-planned protocol

Concurrent
Based on data collected during actual performance of a process already implemented in a manufacturing facility On-going validation Suit manufacturers of long standing, have well-controlled manufacturing process

Retrospective
Based upon existing and/or historical processing data Is not generally accepted

PROCESS VALIDATION
Can be defined as a means of challenging a process during development to determine which variables must be controlled to ensure the consistent production of a product or intermediate.

STEPS IN PROCESS TESTING

Record keeping Evaluation of sources of variation In-Process testing Challenge Approvals

RECORD KEEPING
Standard Operating Procedures (SOPs) Specifications Test Procedures Manufacturing Formulae Manufacturing Instructions Approval Process

STANDARD OPERATING PROCEDURES

Cleaning procedures Environment control Maintenance function Safety House-keeping

Facilities

Control

Personnel

Practices Cleanliness

Equipment

Equipment cleaning Sterilization Maintenance Equipment operation

SPECIFICATIONS
Water content pH range Packaging components Finished product

Reference Material

EVALUATION OF SOURCES OF VARIATION

Materials Machines Methods Men

IN-PROCESS TESTING
CGMP Testing conditions a. Temperature b. Humidity Zone concept

RESPONSIBILITY
Facilities and Environment Equipment Materials Personnel

GUIDELINES FOR PROCESS VALIDATION OF SOLID DOSAGE FORMS

TABLETS SUSPENSIONS

COMPRESSED AND COATED TABLETS

Tablet Composition Process Evaluation and Selection Wet Granulation Equipment Evaluation

TABLET COMPOSITION
Density Particle Size Distribution Surface Area Flow properties Moisture Content

PROCESS EVALUATION AND SELECTION

Blending Operations Color Uniformity Loading Charging Dwelling

WET GRANULATION
Binder Mixed Granulation Drying Milling Operation Tablet Compression Direct Compression Tablet Coating

TEST FAILED

PAN SIZE

SUBCOATING

PAN LOAD

SEAL COAT

TABLET COATING

PAN RPM

BAFFLING STYLE

DRYING TEMPERATURE

SPRAY TYPE AND CLOGGING

EQUIPMENT EVALUATION
Blending Equipment
CAPACITY CHARGING STYLE HEAT JACKET VACUUM

Granulating Equipment
CAPACITY MIXING STYLE SPRAYING TEMPERATURE

Tablet Equipment
COMPRESSION STATIONS COMPRESSION FORCE AUTO WEIGHING CONTROL FEEDING STYLE

Tablet Coating Equipment

SUSPENSIONS
Introduction Facilities Equipment Raw Materials Compounding Microflora Oral suspensions Product Process validation Stability Packaging