STANDARD OPERATING
PROCEDURE
VENDORS QUALIFICATION
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PURPOSE
This Standard Operating Procedure (SOP) describes the steps necessary to ensure suppliers
effectiveness of their quality assurance system and to ensure that the requirements of the
Good Manufacturing Practice (GMP) are being met. It assesses supplier’s reliability as well
as continuous quality of products and services
This SOP is to provide clear guidance for Quality personnel conducting Audits of suppliers.
SCOPE
Applies to the audit of all approved suppliers of Hamim Global Services Limited, Alhaji
Muniru Street Ogombo, Ajah. Lagos.
.
CONFIDENTIALITY
This SOP is a property of Hamim Global Services Limited, Alhaji Muniru Street Ogombo,
Ajah. Lagos.
and remains very confidential. It should not be made available outside the company without
written permission from the Quality Assurance Manager.
RESPONSIBILITY
The Quality Assurance Manager makes a schedule for the audit of all approved suppliers and
communicate to them accordingly through the procurement manager.
The Quality Assurance Manager circulates the report of the audit to all concerned
The Quality Assurance Manager and his/her team monitor all suppliers for compliance and
follow-up audit if need be.
DEFINITIONS
QMS: Quality Management System
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STANDARD OPERATING
PROCEDURE
VENDORS QUALIFICATION
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SOP: Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
RM: Raw Material
R&D: Research and Development
CAPA: Corrective Action and Preventive Action
GMP: Good Manufacturing Practice
Mfg: Manufacturing
REFERENCE
Nil
PROCEDURE
Procedure for inclusion of vendor in approved vendor list (Raw materials)
New vendors shall be qualified and approved by QA department before regular supply of raw
materials.
Purchase department shall locate the new vendor and find out the details of products
manufactured supplied by them. In case of existing materials, Purchase department shall
provide specification to the vendor.
In case of RM source, after the initial assessment, Purchase department shall arrange to get
the Supplier Questionnaire filled by the supplier.
If the Questionnaire evaluation is found suitable, Purchase department after discussion with
R&D and QA shall ask for 3 batches of samples along with certificate of analysis of in-house
& Public Testing Laboratory for quality evaluation and subsequent stability studies.
Purchase department shall arrange to send 3 batches of samples along with New Source
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STANDARD OPERATING
PROCEDURE
VENDORS QUALIFICATION
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Request form to R&D for quality evaluation and stability testing.
R&D shall send the samples along with New Source Request Form to QA Head for
evaluation
New Source Request Form
There are three types of new sources.
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New material from a new source.
Existing material from a new source
New material from an existing approved source.
Evaluation of a New Source
 QC shall analyse the samples sent by R&D as per approved specifications and testing
procedures.

If the samples are found to be in compliance with the specifications, QA shall send
the analytical report to R&D along with the New Source Request Form.

R&D, in consultation with QA shall decide the criticality and necessity of carrying
out usage test and stability studies. The necessity of carrying out machine trials shall
also be evaluated by R&D, in consultation with QA / Production.

R&D, shall carry out the usage test and machine trials, if required. R&D, will also
recommend the need to do stability studies, if required, and communicate the same
with other recommendations to Head QA.

Following the evaluation carried out depending on the criticality of the material, the
Head QA shall recommend an audit of the Supplier’s premises.
Approval of New Source
 The facilities and operations of the supplier’s manufacturing site must be subjected to
a quality audit before the materials are used. Audit shall be conducted by the
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STANDARD OPERATING
PROCEDURE
VENDORS QUALIFICATION
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QUALITY MANAGEMENT
respective Quality function.
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In case when the new material is from an already approved source, the approval may
be recommended based on the pre-approval Questionnaire evaluation after
completing New Source Request form.
If the supplier’s facilities and operations meet requirements as documented in the
audit report then the respective Head QA shall approve the supplier.
The auditor must arrange to send the signed copy of audit report to the audited
supplier.

After approval, Head QA, where the material is used, shall give clearance for
Procurement of procuring a limited quantity of material for use in 3 production
batches and evaluate these three batches critically for quality.

Purchase department shall carefully study the quality aspect and also the quantity and
financial aspects of the vendor, they are as follows:
a) Capability of the vendor to supply the required material within the period.
b) Delivery schedule in order not to affect the production cycle.

Purchase department shall find out the rates quoted by the vendor whether they are
competitive with respect to other vendors without compromising the quality aspects.
On ensuring compliance with specifications the vendor shall be included in approved
vendor’s list.

All the suppliers of RM evaluated by R&D dept. On the basis of process / product
development parameters shall be considered as temporary vendors and based on the
commercial production supply, they shall be transferred to approve vendor list and
shall be considered as approved vendors.
After vendor audit, a vendor audit report classifying the observations as critical,
major and minor with recommended corrective and preventive actions (CAPA) shall
be issued to the vendor within 20 days for audit.

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The Vendor shall reply to the audit report with the action plan on CAPA along with
the expected date of completion of CAPA items.
Written By
Name & Designations
Signature
Date:
Checked By
Approved By
STANDARD OPERATING
PROCEDURE
VENDORS QUALIFICATION
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QUALITY MANAGEMENT

The quality function shall follow up for with the supplier on the implementation and
compliance of the CAPA items suggested in the CAPA plan.
5.5 Procedure for Inclusion of Vendor in Approved Vendor List (Packaging
Materials)
 New vendors must be qualified and approved by QA department before regular
supply of packaging materials.

Purchase department shall locate the new vendor and find out the details of products
manufactured / supplied by them. In case of existing materials, Purchase department
shall provide specification to the new vendor.
 For printed and primary packaging materials, vendor audit is performed by
representative of QA department and GMP Cell.
 Samples of printed packaging materials if necessary shall be submitted to QA
department.

Purchase department after studying the comments of QA department shall inform the
supplier for the supply of the material.
 Based on the product compliance and assessment, further procurement of packaging
material should be continued. On ensuring compliance with specifications the vendor
shall be included in Approved vendor’s list.
5.6 Procedure for Exclusion of Vendor from Approved Vendor List
The vendor shall be disqualified and removed from the approved vendor’s list for the
following reasons :
a) If a lot does not comply to the specification with respect to critical tests then the vendor
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STANDARD OPERATING
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VENDORS QUALIFICATION
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shall be disqualified. The vendor shall be qualified again on further evaluation and
investigation.
b) If a lot does not comply to the specification with respect to minor tests then the vendor
shall be disqualified if it is observed for 3 consecutive lots.
c) 3 out of 10 lots fail to comply the specification in a specified period under review.
d) The delivery schedule is not met for 40% supplies.
e) The rates mentioned in Purchase Order, differs than the rates mentioned in delivery
challan and invoice.
5.6.1 The aspects like the capability of supplier to provide regulatory support, meet the
official requirement shall be evaluated during supplier audit.
5.6.2 The commitment to notify changes to company prior to implementation e.g change in
mfg site, change in process shall be taken.
5.6.3 The commitment to investigate failure promptly in case of any failure reported shall be
assured by the supplier and the capability of supplier shall be evaluated on this front.
5.7 Corrective and Preventive Action
5.7.1 The vendor, who has been excluded from the approved vendor’s list as well as those
which are disqualified and seek inclusion, may be included by only after CAPA verification
of previous items on their satisfactory closure and effective implementation of CAPA.
5.7.2 The vendor shall be made aware of the reasons for his exclusion and shall be asked for
explanation.
5.7.3 Head Purchase, Head QA&QC and GMP Cell shall conduct facility audit of the vendor
in order to ensure that quality system exists in the organization.
5.7.4 Carry out the discussion on other non-quality issues like delivery schedule and rate, etc.
5.7.5 After satisfactory compliance of all above points and ensuring the completion of CAPA
plan, the vendor shall be considered as approved vendor.
5.7.6 The CAPA compliance of previous audit shall be verified in the subsequent audit.
5.7.7 The CAPA verification documents, if any shall be kept along with the audit and
compliance report.
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Signature
Date:
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STANDARD OPERATING
PROCEDURE
VENDORS QUALIFICATION
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QUALITY MANAGEMENT
EXISTING SUPPLIERS:
All existing suppliers shall be audited on a first time basis as scheduled and communicated to
ascertain the level of compliance.
The outcome of the audit will determine frequency of subsequent audits relative to the
supplier in question.
CHOICE OF AUDITORS:
The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the
audit process.
Audits will be led by qualified auditors who are deemed competent to audit the specific
supplier against the required GxP standard or HPL QMS requirements.
THE AUDIT:
Opening Meeting
Attendance at the opening meeting must include the head of the facility or function being
audited or their nominated deputy. An attendance record shall be kept to capture names,
position and signatures of those present at the meeting
Audit
The Audit shall be conducted on the following aspects:
 Quality Management system
 Personnel
 Documentation
 Production
 Complaints and Product Recall
Facility personnel must accompany the auditors at all times to provide information and
responses to questions. If any deviations from the required standard are found, these will be
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STANDARD OPERATING
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VENDORS QUALIFICATION
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highlighted by the auditors at the time they are found during the audit. Objective evidence
will be taken during the audit; this may include photographs, copies of documentation and
records etc.
AUDIT REVIEW
The content of the audit review shall include;


A summary of findings and agreed associated level of risk.
The overall risk rating of the supplier.
RED
YELLOW
GREEN
Relevant Manuals and
Quality Standards, GMPs
not followed leading to
significant risk to product
quality
Potential of non -compliance to
specification(s) but unlikely to
lead to safety, regulatory, major
quality issue, or serious / major
increase in complaints
Product specifications and
all GxP/ Quality standards
being met
Product / Materials are out
of specification and not
identified or critical
tests not performed or out
of specification product /
materials incorrectly
managed
Product or system cannot be
proved to meet legal /
regulatory requirements
Product cannot be proved to
be safe
Relevant Manuals and Quality
Standard, GMP s not followed
leading to minor risk to product
quality
Small number of minor risk
non-conformances found
Significant number of minor nonconformances
Likely risk of recall, major
quality Issue, or serious /
major increase in complaints
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STANDARD OPERATING
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VENDORS QUALIFICATION
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QUALITY MANAGEMENT
CLOSING MEETING
The auditors shall present a summary of the findings to the auditee(s) who must acknowledge
the observations and agree on appropriate CAPA. An attendance record shall be kept to
capture names, position and signatures of those present at the meeting.
THE AUDIT REPORT
The audit report shall have the following details:
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Name and Address of the Supplier Audited
Date of Audit
Auditors
Persons Present(Auditees)
Summary – This shall include the various observations during the audit
The final rating shall be communicated within the audit report.
High Risk(Red): Regular audits (every 6 months)
Medium Risk(Yellow): Audits (Every 1 year)
Low Risk(Green): Audits (Every two years)
The Audit Report and CAPA (see appendix 1 and 2) will be issued to the auditee(s) in a
timely manner (within 5 working days) after the audit; the circulation will include relevant
senior management.
FOLLOW UP
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STANDARD OPERATING
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VENDORS QUALIFICATION
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QUALITY MANAGEMENT
After the audit report is issued and the CAPA have been documented and agreed, the auditee
is responsible for periodically updating the lead auditor with responses to the CAPA plan.
Any proposed changes that may affect the closure dates, or planned action must be agreed
with the lead auditor.
The responses must include objective evidence, and effectiveness checks where appropriate,
to demonstrate completion of the action.
CLOSE OUT OF AUDIT
Once all of the above stages are completed, the audit report and CAPA plan shall be closedout by the lead auditor or designate.
The initial audit status/rating given to a supplier is valid at the time of the audit. Following
satisfactory closure of the identified corrective/preventive actions, the status will be reviewed
and a final close-out rating assigned and communicated.
CHANGE HISTORY & RATIONALE
Date
SOP Ref No
June 2020
QA-030.01
DISTRIBUTION
Department / Functional Area
Quality Management
Production Personnel
Reason For Issue
New Sop
Controlled Copy
Uncontrolled Copy


TRAINING REQUIREMENTS
Quality Personnel/Production/Procurement
Appendix 1:
Doc No:
QA-005/F1
Supplier Audit Report
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PROCEDURE
VENDORS QUALIFICATION
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Name of Supplier:
Address:
Date of Audit:
Auditor(s):
Auditee(s):
Summary of findings
Include positive and negative observations with pictorial evidence
Appendix 2:
Doc No:
QA-005/F2
CAPA
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VENDORS QUALIFICATION
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Name of Supplier
Date of Audit:
Address:
Auditor(s):
Closed
Auditee(s):
Not Closed
Compliance Directive
Total
%
Total Number of
Actions
Total Number of
Closed Actions
Actions Closed
on Time
Actions Not
Closed On time
Overdue Actions
Completion of
All Action
(Date):
S/N Observation Rating Root Corrective Prevent Responsible When Date
Status Comments
cause Action
Action
Completed
/Evidence
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VENDORS QUALIFICATION
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Written By
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Signature
Date:
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