SUN MOON PHARMACEUTICALS PVT. LTD.

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 1 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

1.0 OBJECTIVE:

To lay down the procedure for qualification of vendor for raw materials and packing materials at Sun
Moon Pharmaceuticals Pvt. Ltd.

2.0 SCOPE:

This procedure is applicable for Vendor Qualification who supplies the Raw Materials and Packing
Materials at Sun Moon Pharmaceuticals Pvt. Ltd.

3.0 RESPONSIBILITY:

Purchase:
To identify the vendor
To arrange the evaluation samples from vendor
To arrange the questionnaire and related documents
To co-ordinate for vendor's manufacturing site audit

Store:
To forward the samples, specification along with related documents to Head QC

Quality Control:
To arrange and allocate the work for analysis of samples
To ensure that samples are analyzed as per defined Analytical Test Procedure

R&D:
To arrange for trial batches and give performance result with required comments

Quality Assurance:
To review all documents given by vendor
To monitor and verify all analytical and trial batches
Approval / Rejection of vendor
To maintain the list of Approved Vendor

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 2 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

4.0 PRECAUTIONS:

NA

5.0 PROCEDURE:

5.1 Vendor qualification is part of Quality Management System.

5.2 The Manufacturer and vendor shall be evaluated for all incoming raw material and packing
material.

5.3 Raw materials shall be classified into two categories, namely starting materials and other
materials.

5.3.1 Starting Materials:

5.3.1.1 Starting material shall be defined as

5.3.1.1.1 A raw material, Intermediate or an API that is used in the

production of an API and that is incorporated as a significant
structural fragment into the structure of the API. An API starting
material can be an article of commerce, a material purchased from
one or more suppliers under contract or commercial agreement, or
produced in house. API starting materials normally have defined
chemical properties and structure.

5.3.1.1.2 Starting material is having significant effect on the Quality and

Yield of the product.

5.3.2 Other Materials:

5.3.2.1.1 Other materials shall be defined as a commonly available chemical

/ acid / solvent / catalyst / reagent etc.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 3 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

5.4 Packing materials are classified into Primary and Secondary Packing Materials.

5.4.1 Primary Packing Materials:

Packing materials, which come in direct contact with the product are considered as
Primary Packing Materials.

5.4.2 Secondary Packing Materials:

All packing materials other than primary packing materials are to be considered as
Secondary Packing Materials.

5.5 Vendor Qualification for Starting Materials:

5.5.1 Vendors for the starting materials shall be developed at Process Development during
process development and laboratory validation batches. PDL shall provide relevant
details to plant QA.

5.5.2 The purchase department shall send the vendor questionnaire as per Annexure-I to
vendor and request for Technical Data Package.

5.5.3 The TDP shall contain following details

5.5.3.1 Brief manufacturing process

5.5.3.2 Solvents used in the manufacturing process
5.5.3.3 Impurity profile
5.5.3.4 Working standard profile (If any)
5.5.3.5 Characterization data (if any)
5.5.3.6 Specifications and test procedures
5.5.3.7 TSE / BSE free Certificate
5.5.3.8 Stability studies/ Hold time data
5.5.3.9 Storage conditions
5.5.3.10 Packing details

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 4 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

5.5.3.11 MSDS
5.5.3.12 Certificate of Analysis (COA)
After receipt, purchase department shall forward details to QA.

5.5.4 In case of hazardous material, COA and commitment letter for adherence of quality
from the vendor may be accepted in lieu of vendor qualification samples.

5.5.5 Manager – QA or designee shall review the documents and filled questionnaire for;

5.5.5.1 Capability of vendor

5.5.5.2 Material quality with respect to assay, impurity profile, solvent profile and
other critical tests.

5.5.5.3 Quality Systems available.

5.5.5.4 List of Principal customers

5.5.5.5 Standard of quality based on quality related audit and approval from
various agencies.

5.5.6 Where required Manager – QA or designee shall consult respective group leader from
Organic Synthesis and/or Analytical development Department regarding the route of
synthesis followed by vendor, potential impurities (organic and in organic), solvents
(volatile and non volatile) expected in the material and the adequacy of the existing
method of analysis for the material.

5.5.7 Where needed vendor shall be consulted to include appropriate tests for control of
impurities (by products, degradation products, chiral impurities, isomers, carryover of
reagents used etc), inorganic impurities (sulphated ash, residue on ignition, heavy
metals etc) and volatile and non-volatile solvents.

5.5.8 Commercial supplied material or the evaluation sample shall be analyzed and
evaluate the analytical result as per Annexure-II

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 5 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

5.5.9 Based on the analytical result, user trial shall be performed at R&D and evaluate the
product quality with respect to Assay, Impurity profile, Solvent profile and other
critical test.

5.5.10 If found satisfactory, the said user trial batch of API performed at PDL shall be kept
for three month accelerated stability study. Three month accelerated stability data
shall be evaluated by QA.

5.5.11 After three month accelerated stability study, commercial batches are planned.

5.5.12 Manager – QA / designee shall approve / reject the vendor based on the evaluation.

5.5.13 QA Department shall update the approved vendor list as per Annexure-III and
communicate to Purchase and warehouse departments.

5.6 Alternate Vendors for starting materials of an existing process shall be developed as
given below:

5.6.1 Purchase department shall dully forward filled vendor questionnaire, TDP and
representative samples from three distinct manufacturing lots to QA for further
evaluation.

5.6.2 Quality Assurance shall forward the vendor samples to Quality Control department
with the “Vendor Sample Qualification Request Cum Report” as given in
Annexure-II.

5.6.3 If the samples conform to specifications, Quality Assurance department shall forward
the samples of starting material except natural product to R&D department for
performing lab / plant trials.

5.6.4 Process Development department /(PDL) shall conduct at least one successful
experiment / trial batch and submit the API samples for testing to QC.

5.6.4.1 After testing is complete, production / Process Development shall compile

the data and submit to QA as per below:

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 6 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

5.6.4.1.1Batch processing data.

5.6.4.1.2Stage wise yield data.
5.6.4.1.3IPQC data.
5.6.4.1.4Quality data of Product.

5.6.4.2 Quality Assurance department shall review the vendor assessment

questionnaire, Quality Control analysis reports of vendor samples and
performance experiments by comparing with existing vendor data to
approve / reject the new vendor.

5.6.4.3 Quality head / designee shall approve / reject the vendor based on the
evaluation.

5.6.4.4 QA Department shall update the approved vendor list and communicate to
Purchase and warehouse departments.

5.6.4.5 If found satisfactory, the said user trial batch of API performed at PDL
shall be kept for three month accelerated stability study. Three month
accelerated stability data shall be evaluated by QA.

5.7 Vendor Qualification for Other Raw Materials:

5.7.1 Purchase department shall provide dully filled vendor questionnaire to QA, before
shipment of any material.

5.7.2 First three consignments of the new vendor shall be verified for the quality. On the
basis of the QC results the vendor is approved. The approved vendor list is updated
by QA and communicates to Purchase and Warehouse department.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 7 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

5.8 Vendor Qualification for Primary Packing Materials:

5.8.1 On receipt of filled questionnaire, food grade certificate and representative samples
(three distinct manufacturing lots) from the vendor, purchase dept shall be handed
over this to plant QA.

5.8.2 Quality Assurance department shall forward the vendor samples to Quality Control
department with the “Vendor Sample Qualification Request Cum Report” as given in
Annexure – II.

5.8.3 After completion of analysis, Quality Assurance shall review the vendor assessment
questionnaire, Quality Control analysis reports and approve / reject the new vendor.

5.8.4 Quality Assurance Department shall update the approved vendor list and
communicate to purchase and Warehouse.

5.9 Vendor Qualification for Secondary Packing Materials:

5.9.1 Purchase department shall provide dully filled vendor questionnaire to QA, before
shipment of any material.

5.9.2 If the first three consignments of the material received from the vendor are approved
as per specifications, the vendor is approved. The approved vendor list is updated by
QA and communicates to Purchase and Warehouse department.

5.10 During vendor qualification if initial three samples are not complying as per specification,
said vendor is rejected.

5.11 Approved Vendor list :

1.1.1 Approved vendor list to be prepared as per Annexure-II

1.1.2 Approved vendor list to be numbered as follows

AVL/001

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 8 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

Where,
AVL - Approved vendor list
001 - Revision No. of Approved vendor list
e.g. AVL-001

5.12 Vendor Re-assessment:

5.12.1 Re-assessment of the approved vendors shall be made once in three year for each raw
material/packing material by filling questionnaire as per Annexure-I.

5.12.2 QA department shall update the approved vendor list accordingly and communicate
to purchase and warehouse department.

6.0 LIST OF ANNEXURES / ATTACHMENTS:

ANNEXURE – 1 Vendor Approval Questionnaire SOP/QA/010-F01.00

Vendor Sample Qualification Request Cum
ANNEXURE – 2 SOP/QA/010-F02.00
Analytical Report
ANNEXURE – 3 Specimen Format for Approved Vendor List SOP/QA/010-F03.00

7.0 ABBREVIATIONS:
SOP Standard Operating Procedure
No. Number
NA Not Applicable
REV. Revision
QA Quality Assurance
QC Quality Control
MSDS Material Safety Data Sheet
API Active Pharmaceutical Ingredient
TDP Technical Data Package
R&D Research And Development
TSE Transmissible Spongiform Encephalopathy
BSE Bovine Spongiform Encephalopathy
COA Certificate Of Analysis
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharahtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: VENDOR QUALIFICATION
Department : Quality Assurance SOP No. : SOP/QA/010
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 9 of 9
Prepared By Reviewed By Approved By
Sign. with
Date.

IPQC In-Process Quality Control

TTD Technology Transfer Docket
AVL Approved Vendor List
SM Starting Material
RM Raw Material
PM Packing Material

8.0 REFERENCE:

ICHQ7

9.0 SOP DISTRIBUTION:

Name of Department Department Code

Quality Assurance QA
Purchase PU
Warehouse WH
Quality Control QC
Research & Development RD
Production PD

10.0 Revision AND HISTORY :

REV. NO. REASON FOR REVISION

00 New SOP.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization