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Variety of quality raw material

Can be happen because of :Different of supplier

Different bets from a same supplierDifferent quality in part of one betssuch as top, bottom, and middle

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Raw material consist of :1. Active material

2. Excipients3. Bahan pembantu

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The factor must be consider forraw material

Characteristic fisikokimia of rawmaterialDistribution of particle measureType of particle

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Problem in raw material

Production not developRaw material from supplier and notfrom producerImpor with lower cost in order toeasy to marketed

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Process of validation rawmaterial

1. Make a list all of rawmaterial

2. Find of supplier, mintwo supplier

3. Visiting of factory4. Analysis of

certificate andsampling

5. Make ofspecification

6. Make a procedureof testing

7. Make a procedureof sampling

8. Decide of optimalcondition

9. Decide of storageage

10. Defiance of rawmaterial

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Process of validation rawmaterial

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1. Make a list all of raw materialActive materialExcipients

Chemical substancesOther material for testingPackage

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2. Find of supplier, min two supplier

Prevent from dependenceCost

The product from two supplier willvalidated

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3. Visiting of factory

Make a good relation with thepersonalia in industry of raw material

Observe of sanitation, facility,procedures, production record,identification of material, using of

laboratorium record , laboratoriuminstrument, production instrument, andstaffing

Discussion with personalia

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4. Analysis of certificate and sampling

To know variation and measure ofraw material from a same supplier

and different supplierCan be indicate present of variationbetween lot in specific trial

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5. Make of specification

Specification must be strictcompendium

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6. Make a procedure of testing

Appropriate with method of testing inmonograph

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7. Make a procedure of sampling

The method of taking sample mustbe clear

General requirement : acceptance ofmaterial, amount of container,labelling, measure of sample, and

method of taking sampleSpecific requirement : considerationof sterile product

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8. Decide of optimal condition

Higroskopis,Fotosensitivity,

Sensitivity for high and lowtemperature,Reactivity with package and cover

of container,Capacity of oxidation

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9. Decide of storage age

Limit of expire dateExample : NaCl can be storage in10 years if a storage of NaClappropriately

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10. Defiance of raw material

Defiance of raw material relatedwith specification

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THANK YOU