Biomedical Engineering Reference
In-Depth Information
50.5
attachment forms
abc Pharmaceutical comPany
LEVEL 3
SOP No.: QAS-031
Issued on:
Revision No.:
Initiator name:
ATTACHMENT I
Analysis Request Form
From : Purchase manager
To
: [ ] Quality control manager
[ ] R&D lab director
[ ]
[ ]
Date:
/
/
Subject: Sample of
Manufacturer name:
Supplier name:
Primary
Packaging
Material
Secondary
Packaging
Material
Documentation with Samples
Active
Excipient
(R)
(S)
(R)
(S)
(R)
(S)
(R)
(S)
Vendor approval samples lots
3
1
1
1
Vendor's information (brochure)
✓
✓
✓
✓
Vendor specifications
(1)
✓
✓
✓
Julphar specifications
✓
✓
✓
✓
GMP certificate of the manufacturing site
(2)
or
(3)
(2)
or
(3)
N/A
✓
(2)
Copy of drug master file
(2)
(3)
N/A
✓
(6)
Site master file
-
✓
✓
✓
Manufacturing site license
✓
✓
✓
✓
Relationship letter between manufacturing,
supplier, and Julphar or as applicable
✓
✓
✓
✓
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