QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 484

abc Pharmaceutical comPany

ANNEXURE A

DOCUMENT STATUS CHECKLIST

Company name: Date:

Information provided by: Designation: Signature:

Serial
No.

Documents for Registration with MOH UAE Status* Remarks

1. a. Legalized current GMP certificate issued by

the competent authority in the country of
origin (attested true)

b. Legalized valid manufacturing license issued
by the competent authority in the country of
origin (attested true)

c. List of the products manufactured and/or
assembled by the site

d. Site master file

e. A notarized copy of registration certificate or
GMP evidence from other countries for the
manufacturing site

2. Declaration letter (for suppliers and brokers)

for business association with manufacturer
and the ABC Pharmaceutical Company. Draft
copy attached (Annexure B)

Serial
No.

Other Supporting Documents for Registration
with MOH (Mandatory)

Status* Remarks

1. FDA approval letter

2. Certificate of European suitability

3. Copy of drug master file (open part)

4. Quality questionnaire (self-evaluation

questionnaire)— Annexure C (for nonsterile);
Annexure D (for sterile)

5. Quality agreement, Annexure E

6. Material in-house specification