Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-031.00 Effective date: mm/dd/yyyy
Approved by:
table 50.1
required documents for approval of new vendors
Primary Packaging
material
secondary
Packaging material
documentation with samples
active
excipient
Vendor approval sample lots
3
1
1
1
Vendor's information (brochure)
✓
✓
✓
✓
Vendor specifications
(1)
✓
✓
✓
ABC Pharmaceutical Company specifications
✓
✓
✓
✓
GMP certificate of the manufacturing site
✓
(2)
(2) or (3)
(2) or (3)
N/A
Copy of drug master file
(2)
✓
(6)
(3)
N/A
Site master file
—
✓
✓
✓
Manufacturing site license
✓
✓
✓
✓
Relationship letter between manufacturing,
supplier, and Julphar or as applicable
✓
✓
✓
✓
Letter of FDA approval
N/A
✓
✓
✓
Certificate of European suitability
✓
(1)
✓
(2) (3)
N/A
✓
Supply agreement contract
(1)
✓
✓
✓
Quality questionnaire (Attachment II)
✓
✓
✓
✓
Material safety data sheet
N/A
N/A
✓
✓
ISO 9001:2000
✓
(4)
✓
(4)
✓
(4)
✓
(4)
ISO 14001
✓
(4)
✓
(4)
✓
(4)
✓
(4)
Notes:
(1) If available. (2) FDA approval or certificate of suitability. (3) GMP certificate from the MOH of the country of
origin or FDA approval. (4) Preferable.
7. The vendors qualifying the ABC Pharmaceutical Company specifications will be notified
to the purchase manager by the QC director with a copy to the QA manager.
8. The QA manager will follow up documents from the purchase department or, if required,
directly from the manufacturer/supplier.
9. The material source approved by the QC and QA directors cannot be changed unless oth-
erwise justified and approved by the R&D director in coordination with the regulatory
affairs manager.
10. Each vendor approval/vendor rejection based on the sample analysis will be supported
with comments from the QC manager or director.
11. The QA manager will directly communicate with the vendor to provide the missing
documents.
12. If anomalies or deficiencies are observed, more information will be requested with correc-
tive actions report. Once full compliance is received, the QC manager will update the
master plan with the help of the QA manager.
13. In case of material received from brokers, the supplier will be asked to provide the details
of the manufacturers, including the certificate of analysis issued by the actual manufac-
turer of the material.
14. In case the manufacturer is new, it will pass through the same procedure defined in the
SOP for approval of new vendors, and will be requested to provide all the necessary docu-
ments mentioned in Table 50.1.
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