Wednesday, February 18, 2009

INDUSTRIAL PHARM N REG ASSG OUTLINE:

1. Introduction-explain briefly about the herb

2. Product specification:
a) product description
-indication, dosage form, significant, parameter(eg:polyphenol content should be 10%, if more than that …..)
b) product safety-moisture content, heavy metal content, microbial content
c) product efficacy-concentration, type of tablet (eg:modified release), adverse effects
d) packaging
e)shelf life
f)storage conditions
- API, finished product

3. Production system-equipment, excipient, procedures, clean room specification

4. QC n QA-maintaining product within product specification, more detail on product safety

5. Clinical trials- supporting activities, claims

6. Conclusion

7. References

**can add ur own points, follow dr kausar format, submit on 2nd MARCH 2009 =)
**source=dr Maryanto

3 comments:

Wanbada said...

hantar 2hb March.?!. Ohh syukur..

tamu said...

1500 tu dalam brp page?

geng said...

tak byk. min. 1500ke? ke max?