Table Of Contents (TOC) for OMAN

OMAN

Authority

Oman National Drug Policy

website

www.moh.gov.om/nv_menu.php?fNM=pharma/regulation.htm

if any

DOSSIER REQUIRMENTS

S.No

INDEX

Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg

Page No.

1.

Approvals of the mfg. site(s) where the finished product is manufactured and packed.

2.

Label claim

3.

Unit formula, giving details about empty gelatin capsules and coating material composition used in formulations.

4.

Development Report as per CTD format

5.

Rawmaterial specifications (Active) and test methods. Reference to Pharmacopoeia for material used.

6.

COS/USDMF for active materials, GMP of active material manufacturer. Access to DMF file for active materials.

7.

A declaration letter from the API manufacturer stating that is the holder of COS/DMF and that is supplies the API to the company for mfg.of the finished product.

8.

Rawmaterial specifications and test method (Excipients). Reference to Pharmacopoeia for material used.

9.

TSE/BSE certificate for active and excipients

10.

Supplier’s contact details for active material and excipients

11.

Packaging component specifications and test methods

12.

Supplier contact details about packaging material.

13.

Manufacturing process in details listing all equipment used and In process controls.

14.

Detailed packaging process listing all equipment used and In process controls.

15.

Conditions required for manufacturing and Packaging of products.

16.

Process Validation for manufacturing and Packaging.

17.

Cleaning validation of product.

18.

In process specifications and test methods.

19.

Finished product release and stability specifications, Reference to pharmacopoeia if it is official.

20.

Analytical method for finished product release and stability. Reference to pharmacopoeia if it is official.

21.

Details of reference standards / working standards used.

22.

Validation of test method for Assay, related substance, dissolution etc. as per ICH guidelines.

23.

Pack sizes

24.

Production batch sizes and one filled batch record of Batch manufacturing and Batch packaging record.

25.

Stability protocol

26.

Stability data of three production batches up to shelf life.

27.

In-use stability data

28.

BE report from approved BE center by MOH, UAE

 29.

Comparative dissolution profiles

30.

Compression tooling drawings

31.

10 finished product samples

32.

Samples  of Packaging components

33.

Artworks of Packaging components

34.

Reference information used to prepare the leaflet

35.

Scientific documents – literature on clinical studies, Pharmacology, toxicology, safety & efficacy.