Table Of Contents (TOC) for URUGUAY OR PARAGUAY

URUGUAY / PARAGUAY

Authority

ministerio de salud publica y Bienestar social

website

www.mspbs.gov.py/ http://www.msp.gub.uy/index_1.html

if any

DOSSIER REQUIRMENTS

S.No.:

Documents

Page No.:

1.

Free sale certificate legalized ……………………………………….

2.

GMP certificate ……………………………………………………..

6.

Protocol ……………………………………………………………..

6.1

Proposed name ……………………………………………...

6.2

Design ………………………………………………………

  Primary packing …………………………………………….

Secondary packing ………………………………….……...

  Insert ……………………………………………….………..

6.3

Formula quail-quantitative………………………………..…

6.4

Monograph …………………………………………………

6.4.1

Active Raw Material (Therapeutic Group, ATC Classification, INN,BAN,SDS),

Certificate of analysis supplier and own. ………….

6.4.2

Excipients ………………………………………….

6.5

Packing material specification ……………………………..

6.6

Manufacturing process ……………………………………..

6.6.1

Detailed description of the process ………………..

6.6.2

Formula per batch . ………………………………..

6.6.3

Batch record ……………………………………….

6.6.4

In process control …….……………………………

6.7

Analytical methodology of finished product ………………

6.7.1

Specifications ……………………………………..

6.7.4

Certificate of analysis with spectra,              chromatograms etc ………………………………...

6.7.5

Methodology validation incase no pharmacopoeia method used ………………………………………

6.7.6

Microbiological controls …………………………..

6.8

Stability studies ……………………………………………..

6.8.1

Long term ………………………………………….

6.8.2

Accelerated…………………………….…………..

6.8.3

Duration and schedule ………………..……………

6.8.4

Experimental conditions ………………..………….

6.8.5

Batch size and number………………..……………

6.8.6

Type of packing………………..…………………..

6.8.7

Shelf life propose………………..…………………

6.8.8

Test used during the study………………..………..

6.8.10

Degradation product study………………..………..

6.8.11

Table, number and quantity of batches ……………

6.9

Pharmacology, toxicological studies ………………..….…..

6.1

Clinical studies ………………..…………………………....