Vendor Identification and Qualification

JULPHAR PHARMACEUTICALS PLC.
(ETHIOPIA)
STANDARD OPERATING PROCEDURE (SOP)
SOP NO.: ETQAS-011 CONTROLLED
SUBJECT: VENDOR IDENTIFICATION, QUALIFICATION AND COPY NO.
REQUALIFICATION PROCEDURE REVISION NO.: 6
WRITTEN BY: SENIOR QA PHARMACIST DATE BASED ON: ISO 19011:2018(E)

Sara Tadesse USP-NF 〈1083〉
DISTRIBUTED TO: QA
(Original), Refer Page 1 of 11
distribution index
REVIEWED BY: PLANT MANAGER DATE SUPERSEDES:20-03-2023
Othman Abate
ISSUED ON:
AUTHORIZED BY: QA MANAGER DATE EFFECTIVE DATE:
Tilahun Alemayehu
REVIEW DATE:
1. PURPOSE
1.1 To describe the procedure for identification, qualification and requalification of vendors
supplying the Active pharmaceutical ingredient, excipients, primary and secondary packaging
material.
1.2 To assure that all materials received by Julphar Pharmaceuticals PLC. (Ethiopia) are of
consistent quality and conforming to approved Julphar specifications.
2. SCOPE
2.1 The scope of this SOP addresses the regulatory and cGMP requirements to prove the
suitability of vendors supplying Active pharmaceutical Ingredient, excipients, primary and
secondary packaging material to Julphar Pharmaceuticals PLC. (Ethiopia).
2.2 This SOP is also applicable for requalification of existing vendors.
3. DEFINITION & ABBREVIATION
3.1 DEFINITION
3.1.1 Audit - systematic, independent and documented process for obtaining objective
evidence and evaluating it objectively to determine the extent to which the audit criteria
are fulfilled
3.1.2 Auditee - organization as a whole or parts thereof being audited
3.1.3 Active Pharmaceutical Ingredients (API): Any substance or mixture of substances
intended to be used in the manufacturing of a drug (medicinal) product and that, when
used in the production of a drug, becomes an active ingredient of the drug product.
3.1.4 Excipient: Any compound other than an active ingredient.
3.1.5 Primary Packaging material: The packaging material which comes in direct contact
with the API or drug product.
3.1.6 Secondary packaging material: The packaging materials other than the primary
materials shall be considered as secondary packaging material.
3.2 ABBREVIATION
3.2.1 cGMP: Current Good Manufacturing Practice.
3.2.2 COA: Certificate of Analysis
3.2.3 QA: Quality Assurance
3.2.4 QC: Quality Control
3.2.5 USFDA: United States Food and Drug Administration
___________________________________________________________________________________________
Restricted SOP information, do not release or divulge outside without authorization from QA department approval.
JULPHAR PHARMACEUTICALS PLC. (ETHIOPIA)
SUBJECT: VENDOR IDENTIFICATION, QUALIFICATION AND
REQUALIFICATION PROCEDURE SOP NO.: ETQAS–011
WRITTEN BY: SENIOR QA PHARMACIST DATE

Sara Tadesse REVISION NO.: 6
REVIEWED BY: PLANT MANAGER DATE

Othman Abate SUPERSEDES: 20-03-2023
AUTHORIZED BY: QA MANAGER DATE

Tilahun Alemayehu Page 2 of 11
3.2.6 ISO: The International Organization for Standardization

3.2.7 EU: European
3.2.8 TSE/BSE: Transmissible Spongiform Encephalopathy/ Bovine Spongiform
Encephalopathy
4. RESPONSIBILTY
4.1 Supply Chain Manager / designate is responsible to provide details of vendors, forward self-
evaluation questionnaires and co-ordinate with the vendor for the required documentation and
sample.
4.2 Purchaser is responsible to source materials from only approved manufacturer / Suppliers.
4.3 QC is responsible for analysis of samples received from the vendor and provides the COA.
4.4 Quality Assurance team is responsible for the following:
4.4.1 Review and approve all the documents received from the vendor.
4.4.2 Forward the samples received from vendor to QC and check the COA of the samples.
4.4.3 Co-ordinate with purchaser for any additional samples or document requirement.
4.4.4 Perform site audit.
4.4.5 Approve the vendor.
4.4.6 Include the vendor in the approved vendor list.
4.4.7 Perform vendor re-qualification.
4.5 SOP Compliance is the responsibility of QA Manager.
5. PROCEDURE
5.1 General Procedure
5.1.1 There are two ways of vendor qualification at Julphar Pharmaceuticals PLC (Ethiopia)
5.1.1.1 The vendor approval process can be conducted through Gulf
pharmaceuticals, UAE on behalf of Julphar Pharmaceuticals Ethiopia as per
established technical agreement between Julphar Ethiopia and Gulf
pharmaceuticals Industry (refer the current technical agreement for detail of
the vendor qualification).
5.1.1.2 Julphar Pharmaceuticals PLC (Ethiopia) can do vendor qualification on its
own.
5.2 VENDOR QUALIFICATION BY JULPHAR PHARMACEUTICALS PLC (ETHIOPIA)
5.2.1 IDENTIFICATION, QUALIFICATION AND REQUALIFICATION OF FOREIGN
VENDOR:
____________________________________________________________________________________________



5.2.1.1 Identification, Qualification and Requalification of foreign vendor shall be

done by Julphar Pharmaceuticals PLC. (Ethiopia) based on the current
Vendor Identification, Qualification and Requalification procedure.
5.2.2 IDENTIFICATION OF LOCAL VENDOR:
5.2.2.1 Identify vendors based on one or more of the following criteria (but not limited
to these):
5.2.2.1.1 Adequate financial resources.
5.2.2.1.2 Business practices
5.2.2.1.3 Cost Control.
5.2.2.1.4 Customer satisfaction
5.2.2.1.5 Past performance (If applicable)
5.2.2.1.6 Quality of products
5.2.2.1.7 Regulatory approval
5.2.2.1.8 Timeline for performance
5.2.2.2 For the purpose of vendor qualification, the procedure was classified as
5.2.2.2.1 Qualification Procedure for Vendor of APIs.
5.2.2.2.2 Qualification Procedure for Vendor of Excipients and Primary
packaging materials.
5.2.2.2.3 Qualification Procedure for Vendor of APIs.
5.2.2.2.4 Qualification Procedure for Vendor of printed packing materials
(Labels and leaflets), Secondar and Tertiary Packaging Materials.
5.2.3 QUALIFICATION PROCEDURE FOR VENDOR OF APIs:
5.2.3.1 Supply chain department have to forward the “Self-evaluation questionnaire
for API and Excipients, Attachment ETQAS-011/I” along with Julphar
specification.
5.2.3.2 Supply chain department have to request the vendors to send samples of at
least 3 lots of API which is properly labeled along with COA.
5.2.3.3 The sample quantity for each lot/batch shall be adequate for triple complete
analysis.
5.2.3.4 Up on receipt of the filled and signed Self-evaluation questionnaire with
samples of three lots/batches with COA. Supply chain department shall
forward the documents and samples to QA along with “Vendor qualification
sample submission form, Attachment ETQAS-011/III”.
____________________________________________________________________________________________



5.2.3.5 QA should verify and review all the documents provided by the supplier and
send the sample to QC for analysis along with Analysis Request Form.
5.2.3.6 The analysis of the samples can only begin when the COA and the self-
evaluation questionnaire are approved.
5.2.3.7 QC should test all the samples as per the internal specifications, record all
the results and submit the Analysis Request Form with COA to QA for final
approval.
5.2.3.8 If deficiencies are observed in the samples or documents, more information
should be requested from supplier/ vendor. But if found satisfactory, then
based upon criticality of material, site audit can be done for the vendor.
5.2.3.9 If the review found the documents supplied are unsatisfactory, the
vendor/supplier shall be rejected.
5.2.3.10 Vendor/supplier audit shall be done for all API suppliers.
5.2.3.11 During site audit, fill the “Vendor site audit checklist for API, Attachment
ETQAS-011/IV”. The check list is mainly for guidance and auditor must
evaluate all the requirements as per relevant guidelines or regulations based.
Audit team is from QA and Supply department and additional from any one of
the following members: Plant manager, Production Manager/ designee, QC
Manager/ designee.
5.2.3.12 Audit report must be forwarded to vendor within 20 to 30 days of audit dates.
5.2.3.13 If any discrepancies observed during audit, then vendor has to take
corrective action as per the agreed time lines in audit response which must
be given by vendor within 20 days from audit report. Depending upon
response, Julphar management decides the vendor can be accepted or
rejected.
5.2.3.14 After satisfactory result of site audit, the stated vendor is considered
provisionary approved.
5.2.3.15 After the provisional approval for APIs and successful completion of sample
tests, document review, and self-questionnaires for excipients, three different
batches of the raw material that are enough to manufacture three different
commercial minimum batch sizes shall be procured, and a production batch
shall be manufactured under the supervision of Quality Assurance and
Production, and these three batches shall be subjected to three months of
accelerated and shelf-life stability studies.
____________________________________________________________________________________________



5.2.3.16 Based on three-month stability study results, the Quality Assurance manager
shall give the final Approval of the Vendor, QA shall inform in writing about
the vendor approval for specific material to all concern department.
5.2.3.17 At this point of time “Quality agreement, Attachment ETQAS-011/VII” should
be signed between Julphar and the vendors of critical material before
materials are purchased for commercial batch manufacturing. This will be
coordinated by Supply Chain department.
5.2.3.18 Based upon the following, QA can decide for no site audit for approval of
vendor.
5.2.3.18.1 If vendor is approved with USFDA/ EU/EFDA regulatory
authority.
5.2.3.18.2 If vendor is supplying other materials and is already approved with
Julphar for same manufacturing site/ premises.
5.2.3.18.3 If vendor has a good history for quality of materials.
5.2.3.19 Include the approved vendor in the “Approved vendor list for API and
Excipients, Attachment ETQAS-011/VIII”.
5.2.3.20 Approved vendor list is updated every 12 months. Any new vendor will be
included in the list as addendum to the attachment and updated in main list
during next updating.
5.2.3.21 Flow diagram for vendor qualification is as per “Vendor qualification flow
chart, Attachment ETQAS-011/X”.
5.2.4 QUALIFICATION PROCEDURE FOR VENDOR OF EXCIPIENTS AND PRIMARY
PACKAGING MATERIALS:
5.2.4.1 Supply chain department have to forward the “Self-evaluation questionnaire
for API and Excipients, Attachment ETQAS-011/I” along with Julphar
specification.
5.2.4.2 Supply chain department have to request the vendors to send samples of at
least 3 lots of primary packaging materials which is properly labeled along
with COA.
5.2.4.3 The sample quantity for each lot/batch shall be adequate for triple complete
analysis.
5.2.4.4 Up on receipt of the filled and signed Self-evaluation questionnaire with
samples of three lots/batches with COA, Supply chain department shall
forward the documents and samples to QA along with “Vendor qualification
sample submission form, Attachment ETQAS-011/III”.
____________________________________________________________________________________________



5.2.4.5 QA should verify and review all the documents provided by the supplier and
send the sample to QC for analysis along with Analysis Request Form.
5.2.4.6 The analysis of the samples can only begin when the COA and the self-
evaluation questionnaire is found acceptable.
5.2.4.7 QC should test all the samples as per the internal specifications, record all
the results and submit the Analysis Request Form with COA to QA for final
approval.
5.2.4.8 If deficiencies are observed in the samples or documents, more information
should be requested from supplier/ vendor. But if found satisfactory, the
vendor/supplier shall be taken as approved and shall be included in the
approved vendor list.
5.2.4.9 When the documentation review and sample test results are found
acceptable an on-site audit shall be done. When an on-site audit is not
feasible, remote or virtual audits can be done.
5.2.4.10 Remote or virtual audit will be done with the same check list “Vendor site
audit checklist, Attachment ETQAS-011/V” and with the aim to verify and
qualify the information obtained during the documentation review.
5.2.4.11 Remote or virtual auditing shall be done through video conferences.
5.2.4.12 After the successful completion of site audit, three different batches of the
excipients and primary packaging materials that are enough to manufacture
three different commercial minimum batch sizes shall be procured, and a
production batch shall be manufactured under the supervision of Quality
Assurance and Production, and these three batches shall be subjected to
three months of accelerated and shelf-life stability studies.
5.2.4.13 Based on three-month stability study results, the Quality Assurance manager
shall give the final Approval of the Vendor, QA shall inform in writing about
the vendor approval for specific material to all concerned departments.
5.2.4.14 At this point of time “Quality agreement, Attachment ETQAS-011/VII” should
be signed between Julphar and the vendors of critical material before
materials are purchased for commercial batch manufacturing. This will be
coordinated by Supply Chain department.
5.2.5 QUALIFICATION PROCEDURE FOR VENDOR OF PRINTED PACKING
MATERIALS (PRODUCT LABELS, LEAFLETS), SECONDARY AND TERTIARY
PACKAGING MATERIALS:
____________________________________________________________________________________________



5.2.5.1 For Printed, secondary and further packaging materials one set of samples
for complete analysis as per approved design has to be insisted from vendor
for assessment.
5.2.5.2 When the single sample test result is found satisfactory, the vendor will be
taken as provisionally approved.
5.2.5.3 Up on submitting three consignments satisfying the requirements, the
provisionally approved vendor will be taken as approved vendor.
5.2.5.4 If there is the need for site audit, QA manager shall decide.
Table 1: Relevant documents required for new vendor qualification are as shown in the below
table:
Active Primary Secondary
Excipient
Documentation with samples Pharmaceutical Packaging Packaging
Material
ingredient Material Material
Vendor approval samples lots 3 Lot 3 Lot 3 Lot 1 Lot
Vendor information
   
(Brochure if available)
Vendor specification /COA Testing
   
procedure
License issued by local government
   
authority
Site Master File    ×
GMP Certificate of the manufacturing
   x
site
Certificate or Letter of approval from
USFDA/EU/PIC/S/WHO/EFDA for At least one At least one Optional ×
suitability
Quality Questionnaire    
Process flow    x
Material safety Data sheet    x
ISO 9001:2008/14001 If Available If Available If Available ×
*TSE/BSE Clearance Certificate   If Available ×
Note: after evaluation of samples and documents, Vendor requested to provide below.
Copy of Drug Master File/Dossier (1) If Applicable x ×
____________________________________________________________________________________________



(open part)
Supply agreement contract    
(1) FDA approval letter or Certificate for Suitability.

(2) cGMP Certificate from regulatory authorities of the country of origin.
: Required ×: Not required
TSE/BSE: Transmissible Spongiform Encephalopathy/ Bovine Spongiform Encephalopathy
Note: TSE/ BSE ASSESSMENT: The supplier must be able to certify that all raw materials /
source material and any other materials (i.e. cleaning agent) used at any stage of the
production process comply with the Note for guidance on minimizing the risk of
Transmitting Animal Spongiform Encephalopathy Agent via Medicinal Product
EMEA/410/01 (TSE Guideline, APIC).
5.2.6 QA will provide any relevant document related to vendor to other concerned
departments (For e.g.: Purchase) on request from department manager.
5.3 REMOTE AUDIT PLANNING
5.3.1 Establish audit agreement
5.3.1.1 Discuss with auditee on how to do the vendor audit including the technology
platform selected.
5.3.2 Remote assessment of master documentations
5.3.2.1 This will help in understanding the process and identifying what to look in
more detail
5.3.3 Establishing audit agenda
5.3.3.1 Identify critical areas to be viewed
5.3.4 Opening meeting
5.3.5 Remote audit interview with Subject matter experts (SMEs)
5.3.5.1 Interviews are an important means of collecting information and should be
carried out in a manner adapted to the situation and the individual
interviewed, either face to face or via other means of communication.
However, the auditor should consider the following:
5.3.5.1.1 Interviews should be held with individuals from appropriate levels
and functions performing activities or tasks within the audit scope;
5.3.5.1.2 interviews should normally be conducted during normal working
hours and, where practical, at the normal workplace of the
individual being interviewed;
5.3.5.1.3 attempts should be made to put the individual being interviewed at
ease prior to and during the interview;
____________________________________________________________________________________________



5.3.5.1.4 the reason for the interview and any note taking should be
explained;
5.3.5.1.5 interviews may be initiated by asking individuals to describe their
work;
5.3.5.1.6 the type of question used should be carefully selected (e.g. open,
closed, leading questions, appreciative inquiry);
5.3.5.1.7 awareness of limited non-verbal communication in virtual settings;
instead focus should be on the type of questions to use in finding
objective evidence;
5.3.5.1.8 Request explanation for procedures and data
5.3.5.1.9 Look for evidence of implementation
5.3.5.1.10 Interview with each SMF should not take more than 15 minutes
5.3.5.1.11 the results from the interview should be summarized and reviewed
with the interviewed individual;
5.3.5.1.12 the interviewed individuals should be thanked for their participation
and cooperation.
5.3.6 Closing meeting
5.3.7 Issue reports
5.4 RE-QUALIFICATION OF APPROVED VENDOR:
5.4.1 The standard interval for requalification of all API vendors is once in three years and
for Excipients, primary packing materials and other material supplying vendors is once
in five years. Vendors must be re-qualified only with fresh questionnaire.
5.4.2 Re-qualification of vendor can be also done on the basis of following criteria (other
than standard interval):
5.4.2.1 Material quality received out of specification (For three consecutive lots)
5.4.2.2 Major change in the manufacturing process.
5.4.2.3 Change in manufacturing location.
5.4.3 Based upon criticality of materials approved, vendors site audit matrix is prepared by
QA annually as per “Matrix for APIs and excipients supplying vendors qualification
program, Attachment ETQAS 011/XI”.
5.5 DISQUALIFICATION OF VENDOR:
5.5.1 Vendor shall be disqualified for the following reasons
5.5.1.1 If a lot does not comply to the specification with respect to critical tests, then
the vendor shall be disqualified.
____________________________________________________________________________________________



5.5.1.1.1 The vendor shall be qualified again on further evaluation and

investigation.
5.5.1.2 If a lot does not comply to the specification with respect to minor tests, then
the vendor shall be disqualified
5.5.1.2.1 if it is observed for 3 consecutive lots.
5.5.1.2.2 3 out of 10 lots fail to comply the specification in a year.
5.5.1.3 The delivery schedule is not met for 40% supplies.
5.5.1.4 The rates mentioned in Purchase Order, differs than the rates mentioned in
delivery challan and invoice.
5.6 HANDLING OF DISQUALIFIED VENDOR:
5.6.1 The disqualified vendor may be included only after effective implementation of CAPA.
5.6.2 The vendor shall be made aware of the reasons for his exclusion and shall be asked
for explanation.
5.6.3 After satisfactory compliance of all above points and ensuring the completion of CAPA
plan, the vendor shall be considered as approved vendor.
5.6.4 To ensure the effectiveness of the CAPA implemented site audit will be done based on
QA manager desire.
6. FLOW CHART
6.1 Not Applicable
7. ATTACHMENTS
7.1 Attachment ETQAS-011/I : Self-evaluation questionnaire for API and Excipients
7.2 Attachment ETQAS-011/II : Self-evaluation questionnaire for Packaging materials
7.3 Attachment ETQAS-011/III : Vendor qualification sample submission Form
7.4 Attachment ETQAS-011/IV : Vendor site audit check List for API
7.5 Attachment ETQAS-011/V : Vendor site audit check List for Excipients
7.6 Attachment ETQAS-011/VI : Vendor site audit check List for Packing materials
7.7 Attachment ETQAS-011/VII : Quality agreement
7.8 Attachment ETQAS-011/VIII : Approved vendor list for API and Excipients
7.9 Attachment ETQAS-011/IX : Approved vendor list for primary packing materials
7.10 Attachment ETQAS-011/X : Vendor qualification flow chart
7.11 Attachment ETQAS-01/XI : Matrix for APIs and excipients supplying vendors qualification
program
____________________________________________________________________________________________



8. DISTRIBUTION INDEX
9. DISTRIBUTION INDEX
DISTRIBUTED TO COPY No/ NAME
SUPERSEDES
Quality Assurance REVISION DESCRIPTION OF CHANGE /REASONS FOR
Original
Quality Control NO. REVISIONCopy No. 01
Production and packing 1) Due for revision. Copy No. 02
Supply Chain 2) To change personnel/departments designation as
Copy No. 03
Raw material store (Display) per newly revised site organogram.
Copy No. 04
Sampling room (Display) 3) To include the responsible Copy No.body
05 for the
compliance of this SOP.
01-03-2017 3
4) To incorporate Julphar Pharmaceuticals (Ethiopia)
in the Identification, Qualification and
requalification of foreign vendors (Section 5.1.1).
5) To include Document status checklist in “Self-
Evaluating Questionnaire, ETQS-016/I”.
1) To update the vendor list
26-02-2020 4
2) To include quality of material in the vendor list.
12-10-2020 5 1) Due for revision
1) Vendor qualification systems at Julphar clarified
2) Materials re-classified as APIs; Excipients and
primary packaging materials and Printed materials
(labels and leaflets) and secondary packaging
materials
3) Vendor list made to contain information on
20-03-2023 6
Approval date and requalification date
4) Vendor list separated by material type
5) Vendor list made to contain information about
supplier and vendor.
6) To change the sop number from “ETQS-016” to
“ETQAS-011”
REASON FOR REVISION
____________________________________________________________________________________________

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JULPHAR PHARMACEUTICALS PLC.

WRITTEN BY: SENIOR QA PHARMACIST DATE BASED ON: ISO 19011:2018(E)

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

3.2.6 ISO: The International Organization for Standardization

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

5.2.1.1 Identification, Qualification and Requalification of foreign vendor shall be

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

(1) FDA approval letter or Certificate for Suitability.

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

5.5.1.1.1 The vendor shall be qualified again on further evaluation and

WRITTEN BY: SENIOR QA PHARMACIST DATE

REVIEWED BY: PLANT MANAGER DATE

AUTHORIZED BY: QA MANAGER DATE

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