Vendor Qualification
Purpose
To describe the procedure for vendor qualification and
certification for raw and packaging materials for cGMP
compliance at vendor's (Manufacturer/Supplier) manufacturing site.
Procedure
Vendor Audit: A vendor audit is
a vehicle which is used to inspect and evaluate a vendor's
(manufacturer/supplier) quality management system, as well as its practices,
products and documentation.
Vendor audit procedure:
Vendor audit shall be carried out in following cases
(For Raw Material and Packing Material) if required.
Qualification audit (New Vendor and Alternate Vendor
Development).
Vendor Audit shall cover six systems but not limited
to:
Material
Management
System
Facility and Equipment System
Production
and Process Control
Packaging
and Labeling Control
Laboratory
Control
Quality
Management System
During audit, status of last audit CAPA (Corrective
Action & Preventive Action) shall be verified/ reviewed.
Audit observations to be discussed during audit close
out meeting with auditees.
Audit observations shall be categorized as:
Critical
Major
Minor
Critical Observations: Observations which
directly affects the quality, Safety, Purity of the product & can cause
potential health hazards to customer.
Major Observations: Observations which
indirectly affects the quality, Safety, Purity of product and which are not
complying cGMP practices. Corrective action to be taken immediately.
Minor Observation: Observations which
does not have impact on quality of product, which can be noted and corrected at
scheduled program.
Signed & scanned copy of audit report shall be
issued to vendor through e-mail along with copy to concerned departments within
15 working days from day of audit.
Vendor shall submit CAPA for audit observations within
30 working days from receipt of audit report.
Follow ups for CAPA shall be taken from vendor by QA
personnel. In case CAPA is not received then it shall be the responsibility of
purchase department to provide the CAPA from the vendor.
Based on review of submitted CAPA vendor can be
approved or rejected.
In case of approval of additional Raw material and
Packaging materials from already approved and audited vendor, re-audit of site
is optional. Audit can be done in below cases:
If raw material/ packaging material is manufactured in
new manufacturing block with multiple product facility.
If material is manufactured in new manufacturing block
and is dedicated for said product, then re-audit is not required.
Vendor Audit Schedule:
QAD personnel shall prepare audit schedule for Raw
Materials.
QAD personnel shall prepare audit schedule for
Packaging Materials
Initiate vendor audit in co-ordination with purchase
department as per vendor audit schedule.
Head QAD/Designee shall coordinate with
Head-Purchase/Designee for audit date.
Inform vendor and Head Purchase well in advance
regarding agenda, scope and proposed duration of audit.
Inform all concerned well in advance, in case audit is
preponed or postponed due to some or other reason.
For Raw Materials following updated documents (but not
limited to) shall be obtained from vendor:
For Raw Material:
Vendor
Questionnaire
Material
Specification
TSE/BSE
Declaration
Residual
Solvent Declaration
Material
Safety Data Sheet
Updated
Stability Data
Latest
Regulatory GMP certificates
Declaration
letter in case any change in manufacturing processing
Vendor will be considered as approved in case of:
FDR/ARD recommendation for Bio Batches
/ Trials / Validation to be conducted at site and/ or at FRD.
Satisfactory
vendor audit & compliance.
Satisfactory
review of vendor qualification documents as per procedure.
Note: Batches manufactured using API supplied by un
approved vendor shall not be commercialized prior. The status of vendor shall
be made “Approved” in Designated Software system prior to commercialize of
batch.
Vendor Qualification will be done for:
New
Vendor Development.
Alternate
vendor development.
Vendor
to be raised for New Item code and / or new material which are to be used for
first time.
Development
of another vendor as an alternate source for existing item code.
Procedure for new vendor development (Raw Material):
For initiating the qualification of any new Raw
material supplier/ manufacturer, purchase Department shall forward ABC Limited specification
of the specific Raw material and “Vendor Questionnaire” to vendor.
Purchase department shall receive samples of three
batches quantity sufficient, for 2 QC analysis along with Certificate of
Analysis complying ABC Limited specification, WRS with COA (if required) and
filled “Vendor Questionnaire”.
Vendor should revert with filled “Vendor Questionnaire”
within 15 working days.
Samples along with the Certificate of Analysis and
“Filled Vendor Questionnaire” shall be forwarded to the Head Quality Assurance.
If “Vendor Questionnaire” and Certificate of Analysis
are found satisfactory with the ABC Limited Specifications, QAD shall send the
sample along with COA(Certificate of Analysis) to QCD for analysis.
QAD shall record Vendor sample details.
QCD shall analyze the sample as per the ABC Limited specification.
For API based on the analytical results and Vendor
Questionnaire review, if both found satisfactory intimate to purchase
department and vendor audit may or may not be planned. Vendor can be qualified
based on the analytical results and document provided.
In case of failure, QAD shall communicate the findings
to purchase department to inform the manufacturer.
In case of excipients, vendor may be approved /rejected
on the basis of the provided documentation.
QAD shall intimate to purchase department to arrange
the required documents & sufficient quantity of API, required to take three
trail batches.
If the raw material (API & excipients)
manufacturers has manufacturing unit out of India then RM supplier shall
provide all the required documents and based on the provided documents, vendor
can be approved/ rejected.
Audit shall not be done for those Manufacturer/
Supplier approved by any regulatory agencies and based on the documents
provided, vendor can be approved.
The representatives from Quality Assurance shall carry
out vendor audit.
Vendor Audit shall be carried out to review the vendor
for Quality System, Manufacturing process capabilities, delivery and commitment
to prevent Quality problems based on:
Quality
management system at company premises.
Technical
capabilities of the firm.
Financial
soundness and performance of the company.
Vendor shall be evaluated as per respective “Vendor
Audit Checklist”
Vendor should revert with compliance report within 30
working days.
On receipt of the compliance report from the vendor,
submit the “Vendor Evaluation Form” along with the copy of audit findings and
Compliance report to Head QA. Head QA
reviews the details. If found satisfactory informs the Purchase Department to
proceed for signing the “Audit Closer Note” with the vendor.
Purchase department shall ensure that the “Audit Closer
Note” is signed between the vendor and ABC Limited.
In case a new vendor is approved, include the vendor “Details
of New Approved Vendor”. After three-month review vendor shall be added in
approved vendor list.
QA shall maintain the separate approved vendor list for
Active Raw Materials.
Vendor evaluation and rating summary shall be performed
on yearly basis and same shall be recorded.
Based on trend data, percentage rejects shall be
calculated for each manufacturer and quality rating/score shall be done as per
given blow procedure:
For
example, if a vendor has supplied 25 batches to the plant and 2 out of 25
batches were rejected by QC/complaint received, the percentage rejects shall be
2/25 X100= 8%.
The quality score shall be calculated by subtracting
percentage reject from 100% i.e. 100-8 =92%.
Note: In case percentage is coming out in decimals,
lower side of national numbers shall be considered.
If rating of the vendor goes below the quality
acceptance level then the vendor shall be informed for the same.
On the basis of rating & trend data, Head-QAD shall
give decision to reject for further supply of vendor. Re-approval of vendor
shall be done as per the Vendor Qualification procedure.
Procedure for new vendor development (Packing
Material):
Packaging materials are categorized as primary,
secondary and tertiary material.
Primary Packing Material: The material that
first envelops the product and holds it.
This usually is the smallest unit of distribution or use and is the
package which is in direct contact with the contents. Example : CAN’s, Valves, Actuators etc.
Secondary Packaging Material: The
materials that holds the primary packaging.
Example: Cartons, Plastic tray
etc.
Tertiary Packaging Material: The
material is used for bulk handling, warehouse storage and transport. Example: Shippers,
BOPP tapes etc.
Vendor approval of packaging materials (Primary,
Secondary and Tertiary):
For initiating the qualification of any new Packing
material supplier/ manufacturer, purchase Department forwards the “Vendor
Questionnaire” specific to the Packing materials.
Vendor should revert with filled “Vendor Questionnaire”
within 15 working days.
Purchase department shall receive the filled “Vendor
Questionnaire” and required documents forwards to Head-QAD.
Head Quality Assurance shall review the Vendor
Questionnaire. If Questionnaire found satisfactory Vendor Audit shall be
planned.
In case of primary packing material and printed
material, vendor audit shall be done. However in case of unprinted packing
material and tertiary packing material vendor can be approved on the basis of
provided documentation.
For Packing Materials following updated documents (but
not limited to) shall be obtained from
vendor:
For Packing Material:
Vendor
Questionnaire
Food
Grade certificate
Material
Safety Data Sheet (as applicable)
Solvent
Declaration
Latest
Regulatory GMP certificates
Declaration letter in case any change in manufacturing
Vendor Audit shall be carried out to review the vendor
for Quality System, Manufacturing process capabilities, delivery and commitment
to prevent Quality problems based on:
Quality
management system at company premises.
Technical
capabilities of the firm.
Financial soundness and performance of the company.
If the vendor has manufacturing unit out of India then
PM supplier shall provide all the required documents and based on the provided
documents, vendor can be approved/ rejected. Vendor audit may or may not be
done for those vendor having manufacturing unit out of India
Manufacturer/ Supplier approved by any regulatory
agencies, audit shall not be done for and based on the documents provided
vendor can be approved.
Vendor shall be evaluated as per respective “Vendor
Audit Checklist”
After the vendor audit, any non-compliance observed
during the inspection are compiled and forward to the vendor within 15 working
days after audit closer.
Vendor Audit Report Shall be prepared
Vendor should revert with compliance report within 30
working days.
On receipt of the compliance report from the vendor,
submit the “Vendor Evaluation Form” along with the copy of audit findings and
Compliance report to Head QA. Head QA
reviews the details. If found satisfactory informs the Purchase Department to
proceed for signing the “Audit Closer Note” with the vendor.
Purchase department shall ensure that the “Audit Closer
Note” is signed between the vendor and ABC Limited.
In case a new vendor is approved, include the vendor
“Details of New Approved Vendor”. After three-month review vendor shall be
added in approved vendor list.
QA Shall maintain the approved vendor list for Packing
Materials.
Vendor evaluation and rating summary shall be performed
on yearly basis and same shall be recorded
Based on trend data, percentage rejects shall be
calculated for each manufacturer and quality rating/score shall be done as per
given blow procedure:
For example, if a vendor has supplied 25 batches to
the plant and 2 out of 25 batches were rejected/complaint received, the
percentage rejects shall be 2/25 X100= 8%.
The quality score shall be calculated by subtracting
percentage reject from 100% i.e. 100 -8 =92%.
Note: In case percentage is coming out in decimals,
lower side of national numbers shall be considered.
If rating of the vendor goes below the quality
acceptance level then the vendor shall be informed for the same.
On the basis of rating & trend data, Head-QAD shall
give decision to reject for further supply of vendor. Re-approval of vendor
shall be done as per the Vendor Qualification procedure.
Change in Vendor Name & Address:
In case there is change in vendor name (e.g. From X Ltd to Y Ltd), purchase department
shall intimate to QAD.
In case there is change in vendor manufacturing site
address, purchase department intimate to QAD and provide the technical
documents / enclosures.
Documents like
(but not limited to) change in
manufacturing site declaration, vendor declaration letter for
new manufacturing site
address, declaration for no change
in manufacturing process, vendor questionnaire, material specification, certificate of analysis, residual solvent
declaration, TSE-BSE
declaration, material safety data sheet.
QAD shall initiate the change control for change in
respective documents.
QAD shall perform the site audit of new manufacturing
unit.
Procedure for Inclusion of material with different
Pharmacopoeial grade:
In such cases, vendor shall be treated as new vendor
and new item code shall be assigned.
Purchase shall raise vendor qualification documents as
per defined procedure.
Procedure for generation of new item code for existing approved
material:
In case, there is need for generation of new item code
for existing approved excipient, same
can be done
through Change control
procedure and thereafter
approval of change control same
shall be included in Designated Software.
New Item code shall be generated in below conditions,
but not limited to:
Required
for specific market or customer
Required
for specific product based on criticality
