Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-031.00 Effective date: mm/dd/yyyy
Approved by:
15. The list of approved vendors will provide the names of the manufacturers. The complete
address of the same could be obtained from the certificate of analysis provided by the cor-
responding manufacturers.
50.3.3 r eSPonSiBilitieS of Qa d ePartment
1. The QA manager will review the vendor's assessment form received from the vendors.
2. Once all the documents are received and the QA manager reviews to ensure that the docu-
ments are adequate, the vendor's assessment form will be signed by the QA manager and
approved by the QA director.
3. The assessment questionnaire (Attachment II) response received from the vendor will also
be reviewed by the QA manager and approved by the QA director to assure the vendor is
in GMP compliance.
The list of vendors in the process of approval will be as follows:
List A : Vendors qualifying on the basis of first three successful lots, test history (0% rejection),
and satisfactory document and GMP review
List B : Vendors qualifying a minimum of three lots, with rejection rate 0%, and documentation
and GMP compliance review in progress
List C : Vendors qualifying a minimum of three lots, with rejection rate NMT 2%, and
documentation and GMP compliance review in progress
List D : Vendors qualifying a minimum of three lots, with rejection rate NMT 5%, and
documentation and GMP compliance review in progress
1. Vendor exceeding the rejection criteria of 5% will be communicated for corrective action
or disqualified for a particular material permanently.
2. The QA manager will inform the QA director about critical vendors to be physically
inspected.
3. The QA manager will update the vendor approval master plan on an ongoing basis.
4. The QA manager will prepare the action plan for the vendor approval qualification.
50.3.4 r eSPonSiBilitieS of Qa d irector
1. The QA director will verify critical vendors to be inspected as per the QC manager's
recommendation.
2. The QA director will seek necessary approval from the top management for vendor
inspection.
50.4 reason for revision
First time issued for the ABC Pharmaceutical Company.
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