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 (SOP’s) 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

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