Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-031.00 Effective date: mm/dd/yyyy
Approved by:
50.1 PurPose
To describe the procedure of vendor evaluation to supply the raw materials, packaging materials,
and semifinished bulk of consistent quality conforming to the ABC Pharmaceutical Company's
approved specifications.
50.2 resPonsibility
The QC manager, QA manager, and purchase manager are responsible for following the vendor
approval system. The QC director and quality affairs director are responsible for the SOP
compliance.
50.3
Procedure
50.3.1
r
eSPonSiBilitieS
of
P
urchaSe
d
ePartment
1. The purchase department will send purchasing specifications to the vendor who would
commit his material to comply with the pharmacopeial- and/or Julphar-approved purchas-
ing specification.
2. Based on the specifications, the purchase department shall provide samples at least from
one lot and preferably from three lots to be evaluated by the QC department.
3. All samples should be submitted to the QC department with an analysis request form and
a copy of it is sent to the QA manager (refer to Attachment I).
4. The documentation requirement for each type of material is specified in Table 50.1. It is
the responsibility of the purchase department to provide all the documentation require-
ment specified in Table 50.1 to be accompanied with a vendor approval sample analysis
requirement form at the time of sample submission with a copy to the designated QA
manager.
5. It is the responsibility of the purchase manager to follow all the documents with the vendor
to be responded along with the vendor approval samples.
50.3.2
r
eSPonSiBilitieS
of
Qc d
ePartment
1. All the samples received by the QC department shall be tested as per the pharmacopeial
specifications on FIFO basis or as per the urgency of the material. All samples received
will be entered in a designated register.
2. The sample quantity should be sufficient for at least three complete analysis and should be
kept as a reference sample.
3. A unanimous decision may be taken by R&D, production, and QA directors to request for
a larger sample of material passing analysis for product development experiments when
needed.
4. The QA manager will create a documentation file related to each vendor to keep the records
of testing.
5. Only those vendors meeting the quality level of the ABC Pharmaceutical Company speci-
fication shall be dealt with. The purchase department shall keep the list of vendors approved
by QC/QA.
6. All vendor approval sample analysis shall be carried out on a workbook like all other rou-
tine samples of raw materials.
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