SHRI BMCPER, MODASA NIKITA 1 1 Seminar on VALIDATION PROTOCOLS DEPARTMENT OF PHARMACEUTICS SHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND REASERCH, MODASA-2013 GUIDED BY: Dr. M. R. PATEL Principale & HOD in pharmaceutics PRESENTEDE BY: SAHILHUSEN I . JETHARA M. PHARM – I (2013-14) ROLL NO. - 02
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SHRI BMCPER, MODASA NIKITA 11
Seminar on
VALIDATION PROTOCOLS
DEPARTMENT OF PHARMACEUTICSSHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND
REASERCH, MODASA-2013
GUIDED BY: Dr. M. R. PATELPrincipale & HOD in pharmaceutics
PRESENTEDE BY:
SAHILHUSEN I . JETHARAM. PHARM – I (2013-14)ROLL NO. - 02
SHRI BMCPER, MODASA NIKITA2
LIST OF CONTENTS………
INTRODUCTION TABLETSPHARMACEUTICAL POWDERSORAL LIQUID SEMISOLID DOSAGE FORM
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INTRODUCTIONVALIDATION
It is a documented programme which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications & quality attributes.
Why validation is required? Manufacturers require by law to conform to cGMP. To avoid possibility of rejected or recalled batches.
- To ensure the product uniformity , reproducibility, &
quality
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Validation Protocol
It gives Details of the critical parts of the of the
manufacturing process. Information about the key parameters that are
to be measured. Allowable range of variability in case of
measured parameters. The manner in which the system will be tested.
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Types of validation Prospective Validation:- an experimental protocol is
run before starting of actual use. Concurrent Validation:-In process monitoring of critical
processing steps & end product testing of current production
Retrospective Validation:-It is chosen for established products where their manufacturing processes are considered to be stable ( i.e. long history state of control)
Validation is done for.:- a) Raw materials
b) Process
c) Product.
TABLETS
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It is unit solid dosage forms containing drug substances with or without suitable diluents and prepared by compressing powdered or granulated medicinal substances in die.
Validation
IN CASE OF TABLETS IT IS DONE FOR:-
1. RAW MATERIAL
2. PROCESS
3. PRODUCT
4. FINISHED PRODUCT
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RAW MATERIAL VALIDATION:- Raw material is validated for particle size, surface area,
API + EXCIPIENT POWDER (BOTH ARE IN POWDERED FORM) DOSAGE FORM
Powder are homogeneous mixture of drug/drugs and excipient/excipients in a dry, fine state of subdivision.
It is important to note that term" POWDER” is restricted only to “POWDERS FOR INTERNAL USE ONLY”.
But not used for other powder mixtures. For EX. like powder for external use they rather called as “Dusting powders”.
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POWDERS AS A PRIMARY REQUIREMENT FOR DOSAGE FORM
VALIDATION1. Validation of Raw material
2. Validation of Blending Equipments
3. Validation of Blending operation
4. Validation of final packed material
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1. VALIDATION OF RAW MATERIAL
Physical characteristics of raw material can vary among manufacturers of drug substances.
Inspection should cover the firm’s data for the specification for drug substances.
RAW MATERIAL SPECIFICATION Description, identification, melting range, ph, water,
residue on ignition, chloride, sulfate, sulfide, heavy metals, readily carbonizable substances, total aerobic microbial count, mould and yeast count, E. Coli, acceptable container, approved expiry date, approved suppliers.
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2. VALIDATION OF BLENDING EQUIPMENTS
What is the working capacity of equipment? Does the equipment operate more efficiently with the density
of fluffy powders? What is the working load range, i.e. the proper blender load to
ensure good uniformity of blend? What feature does the equipment have for ease of handling of
powders, automated charging and discharging Can the equipment heat the powder blend if needed for
application as a dryer as well as a granulator? Is the method of heating electric or steam?
May a vacuum be used with the equipment? Does the equipment have the capacity to wet the powder
blend?
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3. Validation of Blending
operation
Determination of the optimum blending time De-mixing or segregation Verification of homogeneity of mixed powders Interaction between process & material Validation of characteristics of blend. -Bulk density -Particle size distribution -Moisture content Load size in blending apparatus Powder flow
Major test parameters used for final product testingAppearance
pH
Viscosity
Specific gravity
Microbial count
Leakage test for filled bottle (By plastic vacuum dessicator)
Check the cap sealing
Fill volume determination
Particulate matter testing
Water vapour permeability test
Stress test
Test parameters specific for suspension • Sedimentation rate• Resuspendibility• Particle size & particle size distribution• Zeta potential measurement
Type of emulsion determination by• Dilution test • Conductivity test• Dye solubility test• COCl2 filter paper• Fluorescence test• Direction of creaming
Test parameters specific for solution • Clarity of solution• Color of solution
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Semisolid Dosage Form
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Process validation protocol
Contents
1. Protocol Approval2. Objective3. Scope4. Validation Approach5. Document Required 6. List of Equipments7. Product Detailed8. Parameter to be tested9. Sampling plan10. Acceptance Criteria