Vendor Evaluation SOP
1.0
PURPOSE:
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1.1. To evaluate/approve product/material to
verify their compliance with GMP, quality, cost and delivery issue(s).
2.0 SCOPE:
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2.1. It covers foreign and local vendors of
all products and materials purchased (except promotional items) once the vendor
is approved, it is considered an important player of ______ Pharmaceuticals
team.
3.0 RESPONSIBILITY:
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3.1. Director
3.2. QC Manager
3.3. Admin Manager
3.4. QA Manager
4.0 PROCEDURE:
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4.1. General:
4.1.1. Multiple
approved vendors are maintained whenever possible to ensure material availability
of all items.
4.1.2. Sufficient
quantity of Raw / Packing materials is taken from new vendors.
4.1.3. These
samples are provided to Quality Control Department for testing and analysis.
4.1.4. In
case of new product after approval of QC Department sample is provided to
R&D Department for trial batch.
4.1.5. In
case of running product after detailed QA sampling and approval by QC / R&D
vendor evaluation report is issued and the vendor is informed.
4.1.6. Annually
review the quality attributes and prepare the trend analysis.
4.2. Selection
Criteria for Vendor of Active Pharmaceutical Ingredients (API):
4.2.1. The
Vendor of API will provide the following for approval/Qualification:
4.2.1.1. COA
of said API.
4.2.1.2. API
Stability data.
4.2.1.3. MSDS
of the said material.
4.2.1.4. Valid
GMP certificate.
4.2.1.5. Sample
of 3 different lots (If material of vendor is approved from USFDA/ WHO/ ICH
then these samples may be omitted).
4.2.1.6. CoA
of 3 different samples of 3 different lots.
4.2.1.7. Preferably
reference standard of said materials along with of impurities. In case of
non-availability of reference standard working standard will be provided along
with COA.
4.2.1.8. Validated
analytical method (in case of non-compendial API)
4.2.1.9. Customer
list for cross reference.
4.2.1.10. Any
Accreditation from USFDA /WHO /ICH
4.3.
Selection Criteria for Excipients Vendor:
4.3.1. The
vendor will provide the COA of materials.
4.3.2. Customer
list will also be provided for cross reference.
4.4. Selection
Criteria for Primary Packing Material Vendor:
4.4.1. Sufficient
quantity of each item along with printing specimen (Where applicable) is taken
from new vendors.
4.4.2. Specifications
of material i.e. Al foil will be provided before Qualification.
4.4.3. Where
applicable drawing will also be provided.
4.4.4. Machine
trial where applicable will also be performed.
4.4.5. After
being satisfied with the information provided by the vendor and evaluation of
items by the QC, the vendor is approved or rejected for that item.
4.5. Selection
Criteria for Secondary Packing Material Vendor:
4.5.1. Client
list / Brochures / Details are asked from the vendors.
4.5.2. Preliminary
study / review of the above information will be done by the purchase department.
4.5.3. The
vendor should be capable for designing the packing components.
4.5.4. The
vendor will be bound to provide specifications of card, paper etc.
4.5.5. He
will also provide Master Copy of design as reference.
4.6. Condition
under which an on-site audit of a local vendor will become mandatory:
4.6.1. All
local API (Active Pharmaceutical Ingredients) manufacturer to be visited and
Vendor Evaluation Checklist are to be filled in case of non compliance of
conditions mentioned in section 2.
4.6.2. In
case of non API vendors, if there are repeated complaints of quality/delivery.
4.6.3. In
case of packing components compliant of mix up of different packing components
is observed.
5.0
REVIEW FREQUENCY:
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SOP will be reviewed at least annually.
EVIDENCES OF RECORDS & REFERENCES
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API Vendor Approval (F-07-010)
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FORMAL KPIs (Key Performance Indicators)
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No. of vendors approved or rejected,
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GENERAL RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Vendor approved without fulfilling any of the
requirements
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Product quality
will suffer
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Do not qualify the vendor until unless all necessary
data/items have been provided
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QA Manager/
QC Manager
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Machine trial has not been performed for packing
material
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Material may get problematic while on machine
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Always perform a machine trial for all those packing
materials whose trial is necessary and recommended
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Vendor audit has not been done after
non-compliance
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Chances of repetition of non-compliance and
product may suffer
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Auditing the vendor is a must condition whenever a
non-compliance observed regarding material
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