VALIDATION OF RAW MATERIAL

Idil Farhan 0811012058 Faculty of Pharmacy Andalas University

Variety of quality raw material Can be happen because of : Different of supplier Different bets from a same supplier Different quality in part of one bets such as top, bottom, and middle

Raw material consist of : 1. Active material 2. Excipients 3. Bahan pembantu

The factor must be consider for raw material

Characteristic fisikokimia of raw

material Distribution of particle measure Type of particle

Problem in raw material

Production not develop

Raw material from supplier and not

from producer Impor with lower cost in order to easy to marketed

Process of validation raw material

1. Make a list all of raw
2. 3. 4.

6. Make a procedure

5.

material Find of supplier, min two supplier Visiting of factory Analysis of certificate and sampling Make of specification

of testing 7. Make a procedure of sampling 8. Decide of optimal condition 9. Decide of storage age 10. Defiance of raw material

Process of validation raw material

1. Make a list all of raw material

Active material
Excipients Chemical substances Other material for testing Package

2. Find of supplier, min two supplier

Prevent from dependence Cost The product from two supplier will

validated

3. Visiting of factory
Make a good relation with the

personalia in industry of raw material Observe of sanitation, facility, procedures, production record, identification of material, using of laboratorium record , laboratorium instrument, production instrument, and staffing Discussion with personalia

4. Analysis of certificate and sampling

To know variation and measure of

raw material from a same supplier and different supplier Can be indicate present of variation between lot in specific trial

5. Make of specification
Specification must be strict compendium

6. Make a procedure of testing

Appropriate with method of testing in monograph

7. Make a procedure of sampling

The method of taking sample must

be clear General requirement : acceptance of material, amount of container, labelling, measure of sample, and method of taking sample Specific requirement : consideration of sterile product

8. Decide of optimal condition

Higroskopis,

Fotosensitivity,
Sensitivity for high and low

temperature, Reactivity with package and cover of container, Capacity of oxidation

9. Decide of storage age

Limit of expire date Example : NaCl can be storage in

10 years if a storage of NaCl appropriately

10. Defiance of raw material

Defiance of raw material related

with specification

THANK YOU