Vendor qualification is done for Raw material (Active Pharmaceutical
Ingredients/Excipients), Packaging Material (Both primary, secondary packaging
material) or any other materials.
DEFINITION:
Vendor: Who manufactures and supplies the materials (API, Excipients, and
packing material) to customers.
Supplier: Who supplies materials to customers on behalf of vendor
API: API is defined as any substance or mixture of substances
intended to be used in the manufacture of a drug product and has
pharmacological activity.
Excipients:
An ingredient added intentionally to the drug substance which does not have
pharmacological properties in the quantity used.
Packaging Material: Any material employed in packaging of medicinal
product, excluding any outer packaging used for transportation and shipment.
1.
Primary Packaging Material: Vials/Ampoules/PFS/Rubber stoppers/ Aluminum
Seals/LDPE Granules for BFS/LDPE Bottles/LDPE nozzle/HDPE Cap
2.
Secondary and Tertiary Packaging Material: Example: Cartons/ Labels/
Leaflet/ Others.
Vendor
Identification:
API
and Excipients -- identified by FRD in coordination with Purchase
Packaging
Material -- identified by PRD in coordination with Purchase
Quality
Assurance -- coordinate the vendor qualification process with Purchase, FRD and
PRD
Vendor
Qualification for API, Excipients, Packing material:
Purchase
Department initiates the vendor qualification process for new/additional /
alternative vendor(s).
Incase
of outsourced API’s, three lots of API samples are analyzed by FRD and
specifications are finalized accordingly.
API’s:
In
house API’s : single lot sample is analyses Outside API’s: 3 lot samples to be
analyzed Excipients : Only one lot sample is analyzed
Manufacturing
sites, which are registered with either ISO or have submitted their DMF to EU
can be approved base on Audit Questionnaire
Vendor
qualification questionnaire is forwarded by QA
purchase Vendor which includes
Part
– A –General Information Part – B – Technical Information
Part
– C – Material Specific information
The
manufacturer questionnaire is accepted, if it meets our requirements for any
material having VQ of that material in other Aurobindo units shall be evaluated
based on the questionnaire
Revised VQ questionnaires or specifications
are forwarded to purchase department
Get the filled Vendor Qualification
Questionnaire
QA
has to assess the vendor based on Part
A,B,C
Provisional
Approval - during initial vendor evaluation and VQC is prepared
Provisionally Approved Vendor shall be
evaluated based on Exhibit batch stability data.
Satisfactory on –site inspection
Vendor
evaluation is completed before commercial batches.
In
house API -final approval is given based on
Evaluation
of questionnaire
Exhibit
batch stability data
In case of sterile API:
Evaluation
of Questionnaire
Evaluation
of lot sample Analysis
Satisfactory
on –site inspection
Vendor sites in India -audited by QA and QC
Outside
India -audited by QP or third party.
Vendor
audit for API is conducted as per Check list
API
material storage other than room temperature, transport validation documents
are verified before the final approval of the vendor.
New
material Existing vendor-part-c & statement of agreement and onsite
inspection during periodic requalification
Alternate
vendor qualification -Initiate Change request
Packaging material
One
time Approval - ERP for procurement of the Packaging Material for Machine
trial.
Printed
and unprinted packing materials-Evaluated based on
Evaluation of Questionnaire
On
–site inspecti
Vendor
Requalification-qualified periodically
When
Failures observed in critical parameters (Assay, Microbial count Etc...)
Site
transfer of the supplied material.
Requalification
is done based on
On
site inspection
Quality
system certificate by official accredited body self –assessment report (By
vendor)
Requalification
criteria
Active Pharmaceutical Ingredient (API):
Once
in 2years+ 30 days Excipients:
Once
in 4years + 60 days. Primary Packaging Materials:
Once
in 4years + 60 days Printed & unprinted Packaging Materials:
Once
in 4years + 60 days
Vendor
Disqualification
Consistent
quality product is not provided as per specification.
First rejection of a consignment –Caution
letter (detailed investigation report with CAPA )
Rejection
parameter is serious in nature (Failure in Assay, Microbial contamination-
vendor site audited)
Second
rejection- Warning letter (Reason for failure, IR, CAPA)
Third
rejection- Vendor Black listed
QA
forwards notification to all departments and to vendor through purchase
department
ConversionConversion EmoticonEmoticon