Checklist for Product for Registration
Brand nan1e :.... .. .. .. ... ............................... ...... ............ ...... Pack size .. ........... .. ....................... .
a111e & Strength .... . ... . .............. . .................................. ............ .................... .............................. ..
INN
atne & Country ........ . ... .............. . ......... .... .. ... .. ............... .. ... .. ....... .. ... Category .. .... .... . .
Mf.
No.
A
1
2
3
4
5
PART I
AOMINISTRA TIVE DATA & PRODUCT INFORMAMATION
Certificate of Analysis from Cambodia NQC
Application form for Registration
Brand Name C learance
Manufacturer registration
Letter of Authorization
Original Cer·tificate of ~l Pharmaceutical Product ( CPP )
Summar-y of Pr·oduct Chat·actedstic ( SPC)
PART II QUALITY DOCUMENT
BODY DATA
A-Drug Substance
Sl : General Information
S2 : Manufacture
S3 : C haracter ization
S4 : Control of Drug Substance
85 : Refere nce Standards or Materials
S6 : Container C losure Svstem
S7 : Stabilitv
B-Drug Product
PI : Desc.-iption and Composition
P2 : Phannaceutical Development
P3 : Manufacture
P4 : Control of Excipients
PS: Control of Drug (Finished) Product
P6 : Reference Standards and Materials
P7 : Container Closure Svstem
P8: Pr·oduct Stability
P9: BE Study
PART Ill Non Clinical Data
PART IV Clinical Data
Sample
6
7
B
c
~.
E
Yes
No
Receptionist Comment : .......................... ... ............. .... ...... .............. ...................... . .. .. .
Evaluator Signature and date : ................................................ ... ...... ... ... ......... ............. .
Recheck b:v C hef Bureau
•
Pharmacist Lol< Saphy
Remark