DEEPAK CELLULOSE PRIVATE LIMITED Page

STANDARD OPERATING PROCEDURE 1 of 6

VENDOR EVALUATION AND PURCHASING PROCESS Doc. No. P841AD01
Title Ref: QM D441QA01- 8.4.1 Revision No. 07
Department QA/ADM/PUR Effective Date 01/11/2023
Copy Supersedes Rev No & Date 06; dated : 01/02/2022 Review Date 31/10/2025

1.0 OBJECTIVE:
To ensure that all In-Coming Raw Materials, Packing Material and Services are controlled effectively
to prevent Adverse Impact on the Quality of Excipients manufactured at Deepak Cellulose Pvt. Ltd.

2.0 SCOPE:
This Procedure is applicable to all Activities and Documents related to the Purchasing process.

3.0 DEFINITIONS / GLOSSARY / ABBREVIATION :

3.1 Vendor Questionnaire: A set of Questions that shall be evidence an understanding of the Quality
System employed by the Vendor.
3.2 Purchase Order (PO): An Order Form which provides Details of the Material Required, Vendor
Identity and Address, and other Purchasing Information and Terms and Conditions agreed to between
Deepak Cellulose Pvt ltd and the Vendor in F1P841AD01.
3.3 ABBREVIATION :
PO Purchase Order AD Administration
QC Quality Control QA Quality Assurance
HPMC Hypromellose Methyl Cellulose COA Certificate of Analysis
MSDS Material Safety Data Sheet GMP Good Manufacturing Practice

4.0 RESPONSIBILITY:
Purchase Personnel To identify new vendor, communicate them and get complies for their
evaluation and document requirements. Implementing this procedure.
QA Head/Designee Approval of Vendor as per this SOP and compliance with EXCiPACT

5.0 ACTIONS / PROCEDURE:

5.1 List of Approved Vendors:

Note: Approved Vendor Contains Approved Manufacturer Name and Address. and Approved
Supplier Name and Address
5.1.1 QA and Purchase/Administration shall prepare a list of Approved Vendors for Raw Materials in
F8P841AD01 as per approval received from Head QA. The Approved Vendors shall be evaluated on
basis of Repeated Quality Approved Consignments, Delivery Schedule Maintenance, Competitiveness
in Prices, Vendor audits (whenever carried out) and Capacity of the Vendor to meet the Volume of
Requirement.
5.1.2 Service Contractors related to QC shall be approved and listed by QC and Purchase/Administration
Departments in F12P841AD01 on basis of Type of Service, Quality of Service Provided, Promptness
of Service and Terms of Payment.
5.1.3 Service Contractors for Maintenance of Electrical, Mechanical, Construction, Plumbing, Painting,
waste Operations, Pest Control, Garden, etc, shall be approved by maintenance and administration
departments on basis of quality and promptness of service and listed in F9P841AD01.

QA/ADM. Prepared By Checked By Approved By

Name Ashwin K Patel (QA) Mitesh A. Shah (GM) Russell M Durham(Head QA)
Sign./Date
FOR RESTRICTED CIRCULATION ONLY
 DEEPAK CELLULOSE PRIVATE LIMITED Page
STANDARD OPERATING PROCEDURE 2 of 6
VENDOR EVALUATION AND PURCHASING PROCESS Doc. No. P841AD01
Title Ref: QM D441QA01- 8.4.1 Revision No. 07
Department QA/ADM/PUR Effective Date 01/11/2023
Copy Supersedes Rev No & Date 06; dated : 01/02/2022 Review Date 31/10/2025
5.1.4 All quality and GMP related service providers shall be approved by QA Head on basis of experience,
capability, status of the provider in the particular field of operation and terms and conditions, and listed
in F10P841AD01. The list shall also contain Quality and regulatory service providers and key
consultancy providers approved by administration.
5.1.5 A Registration Form F2P841AD01 shall be sent out to the Suppliers and an Evaluation of their
Performance shall be carried out. Necessary Certificates/ Authorizations will be collected from these
Vendors by Purchase department and to be submitted to QA.
5.2 Personnel involved in Purchasing Process

5.2.1 The Purchase Officer/Provider shall have thorough Knowledge of the Activities and shall have a
sufficiently high Educational Background with experience in the Purchasing Field.
5.2.2 The Personnel involved with the routine Preparation of Documents related to the Purchasing Operations,
such as Purchase Orders, Invoices of Materials, should be Qualified, preferably Graduate, Competent
and have good Knowledge of the System, including knowledge of Labeling, Grades of Materials, Codes
of different Materials, Purchasing System, Production Requirements and Lead Times Required for
various Materials.
5. 3 Purchasing Process & Validation of Vendors:

5.3.1 Starting Materials shall be purchased from Approved Vendors. Vendors shall be Approved for the
following Raw Materials but not limited to: HPMC, Phthalic Anhydride, Hydrogen Peroxide, Sodium
Acetate, Acetic Acid, Acetic Anhydride, Succinic Anhydride, and Cellulose Acetate. The Approved
Vendors shall be Validated 3 or 5 Years for Quality of the Raw Material supplied, Promptness of
Delivery, and Commercial Terms and Conditions. Evaluation/Validation of Vendors shall be carried out
as per Evaluation of Supplier Form F3P841AD01.
5.3.2 Each Material shall be identified by Code, where necessary, and have Established Specifications,
which shall be made available with the Purchasing Authority.
5.3.3 Materials shall be purchased according to the Schedule made out for each of them in Consultation with
Production Department or when requested from the Relevant Department From approved venders.
5.3.4 Each Purchase Activity of a Critical Item or Service shall include a Preliminary Verbal/
Telecommunication of the Terms and Conditions before the final Purchase Order in Form
F1P841AD01 is made. For Suppliers supplying the same Materials/Service on a long term basis, a
Purchase Order can be directly made for approved manufacturers.
5.3.5 Each new Vendor shall be Approved for supplying Materials on basis of their 3 Consecutive batch
Samples meeting Established Specifications. An Evaluation based on the Audit/Questionnaire as well
as Quality Tests on the actual Samples of material will be made to validate the Vendor.
5.3.6 As some of the Materials are Imported it may not be feasible to Audit the Suppliers/Vendors. If these
Suppliers are not agreeable to fill the Questionnaire Forms, alternatively they may be qualified on basis
of the Samples Tested as per Compendia on basis of their ISO or GMP certificated reputation in
market in terms of their value customers list as well as to In-House Requirements such as appearance
of the Material, Foreign Particles, Size, Color, etc. They can provide their standard Quality manual or
questionnaire for their vendor approval.

QA/ADM. Prepared By Checked By Approved By

Name Ashwin K Patel (QA) Mitesh A. Shah (GM) Russell M Durham(Head QA)
Sign./Date
FOR RESTRICTED CIRCULATION ONLY
 DEEPAK CELLULOSE PRIVATE LIMITED Page
STANDARD OPERATING PROCEDURE 3 of 6
VENDOR EVALUATION AND PURCHASING PROCESS Doc. No. P841AD01
Title Ref: QM D441QA01- 8.4.1 Revision No. 07
Department QA/ADM/PUR Effective Date 01/11/2023
Copy Supersedes Rev No & Date 06; dated : 01/02/2022 Review Date 31/10/2025

5.3.7 Each Purchase Order shall have the following Details:

1. Vendor Name and Address.
2. Date of making the Purchase Order (PO).
3. Validity of the PO.
4. Type of Materials Ordered – Raw Materials/Engineering Purchases/Capital Goods.
5. Vendor/Supplier Code
6. Quotation Reference.
7. Purchase Order No.
8. Material Code of Item to be Purchased.
9. Material Description/In-Coming Specifications
10.Commercial requirements such as Unit/Rate/Quantity/Basic Total Cost/Discounts/
Packing & Forwarding Requirement/ Duties & Taxes as Required.
11.Departments to which Copies are Assigned to.
12.Authorized Signatory
13.Terms and Conditions, include: Expected Delivery Date/Payment schedule & Mode of
Payment/Bill & Challan Requirement/Transportation Mode and schedule/Other Requirements.
5.4 Evaluation of Equipment Manufacturers:
5.4.1 To facilitate the smooth growth of the company, we need to have a Proper Relationship with
Equipment Manufacturers, who play an important part in ensuring that we end up getting machines that
are efficient and reliable. We need to Check our Machine Suppliers Before purchasing.
5.4.2 The Director with engineers shall Evaluate the Suppliers with respect to the Quality of Workmanship,
Delivery Time, Costs, Supplier’s List of Customers and Years of Experience.
5.4.3 If required, he shall visit the Supplier himself or depute a Representative, to gauge the Quality of
Workmanship at the Manufacturer’s Facility from time to time in case of Repeated Orders.
5.4.4 Repeated orders to the same Manufacturer shall establish that the Supplier is Validated
5.4.5 Laboratory Equipment will be procured from Reputable Manufacturers or from their Agents and After
Sales Service will be a Parameter in Validation of the Manufacturer.
5.4.6 Second Sales Equipment procured by the Company shall be done on as is where basis is and Decisions
shall be taken on basis of Director’s Experience and Competency. Check whether machine is complies
as per User requirement or not?

5.5 Receipt of Materials & Services:

5.5.1 On receipt of Materials and Services, Purchase /Administration Department Personnel shall verify that
the Bills / Challans are as per Terms agreed to.
5.5.2 After Verification of the Quantity, Integrity of Seals where applicable and Preliminary Quality Tests
by QC/Relevant Departments, and Due Communication of this to the Purchase Department,
Purchase/Stores Personnel shall stamp ‘Received’ and Date and Sign all the Copies of the Bills /
Challans.
5.6 Vendor Qualification & Audits: F4P841AD01 and F6P841AD01
5.6.1 Vendor Audits shall be carried out, if necessary, for Critical Raw Materials.
QA/ADM. Prepared By Checked By Approved By
Name Ashwin K Patel (QA) Mitesh A. Shah (GM) Russell M Durham(Head QA)
Sign./Date
FOR RESTRICTED CIRCULATION ONLY
 DEEPAK CELLULOSE PRIVATE LIMITED Page
STANDARD OPERATING PROCEDURE 4 of 6
VENDOR EVALUATION AND PURCHASING PROCESS Doc. No. P841AD01
Title Ref: QM D441QA01- 8.4.1 Revision No. 07
Department QA/ADM/PUR Effective Date 01/11/2023
Copy Supersedes Rev No & Date 06; dated : 01/02/2022 Review Date 31/10/2025

5.6.2 It shall be sufficient for the Vendor to fill out a Supplier Approval Questionnaire with consecutive 3
batch COA to be tested at DCPL. Form F4P841AD01 For Active Raw Material and F6P841AD01 For
Packing Material and In Active RM form manufacture record of Raw Material to Qualify the Vendor,
if Purchase/QA/QC Departments are satisfied with the Quality System of the Vendor/ Manufacturer of
the Raw Material as professed by them. This is necessary as the Basic Raw Materials used are being
imported into the Country. Various certificates/authorizations shall be required to be attached with the
Supplier Approval Questionnaire.
5.6.3 Many of the Main Raw Materials such as Acetic Acid, Phthalic Anhydride and Hydrogen Peroxide are
manufactured in large Capacity, Dedicated Continuous Process Plants run by Reputed Multinational
Companies, with Established Quality Systems and need not be Audited. Supplier Approval
Questionnaires sent to these Companies may not be addressed as our Requirements are very low,
considering the size of their Plants. A Certificate of Analysis and ISO Certificates from these
Manufacturers is sufficient for qualifying the present Vendors of these Materials.
5.6.4 Vendor Audits, if carried out, shall be made by senior QC/QA Personnel alone or along with or
without and QA/QC Senior Staff Purchase Department Personnel. A Vendor Qualification Team
comprising the Director and QA Manager is formed to evaluate the Vendor Qualification
Audit/Supplier Approval Questionnaire duly filled and signed by the Auditee Company
Representative.
5.6.5 Vendor Audits shall be made as per Vendor Approval Questionnaire F4P841AD01 and Auditor shall
make Written Comments in his Audit Report and sign the Questionnaire. An Evaluation based on the
Audit/Questionnaire as well as Quality Tests on the Actual Samples of Material will be made to
validate the vendor.
5.6.6 Final Approval of Vendor shall be made by QA Head, with reference to Vendor Questionnaire and
Inputs from Administration/Purchase Department.
5.6.7 After QA Approval, Vendor shall be Qualified and this shall be communicated to all Concerned
Departments to be updated in approved vender list.
5.6.8 Re-Distribute the Vendor Questionnaires to each approved in provisional approved vender list vendor
after a period of 3 years.

5.7 New Critical Raw Materials Suppliers Evaluation & Qualification:

5.7.1 When Critical Raw Materials are being supplied by new Suppliers, an evaluation of the Suppliers shall
be carried out as follows by QC Department:
5.7.2 QC to Request for COA of the material to be supplied by potential vendor.
5.7.3 If COA is OK, request for samples of three consecutive batches and evaluate as per the respective
material specifications and Test Methods SOPs available for that Material.
5.7.4 If samples are OK list the vendor as approved. If not OK reject the vendor.
5.7.5 The Evaluation shall be carried out as per Form F3P841AD01 by the purchase and QC Department on
the basis of the Consistency of Quality of the Raw Material supplied, compliance of the COA of the
Supplier with current specifications and other Documents such as MSDS availability.

QA/ADM. Prepared By Checked By Approved By

Name Ashwin K Patel (QA) Mitesh A. Shah (GM) Russell M Durham(Head QA)
Sign./Date
FOR RESTRICTED CIRCULATION ONLY
 DEEPAK CELLULOSE PRIVATE LIMITED Page
STANDARD OPERATING PROCEDURE 5 of 6
VENDOR EVALUATION AND PURCHASING PROCESS Doc. No. P841AD01
Title Ref: QM D441QA01- 8.4.1 Revision No. 07
Department QA/ADM/PUR Effective Date 01/11/2023
Copy Supersedes Rev No & Date 06; dated : 01/02/2022 Review Date 31/10/2025

5.7.6 Every three Years Each Raw Material supplier shall be evaluated with separate Form, even if the
Supplies more than one Raw Material in a consignment i.e the Supplier shall be separately evaluated
for each Raw Material that is supplied on separate Forms F3P841AD01.
5.7.7 When Critical Raw Materials are being supplied by new Suppliers without the initial receipt of COAs
or samples, an evaluation of the Suppliers shall be carried out on the first three deliveries affected by
the Supplier.
a) When each of the first two consignments are evaluated and found OK the vendor shall be
provisionally approved with provision approved form F5P841AD01in provisional approved vender
list.
b) When the third consignment also passes, the vendor shall be fully qualified by admin GM.
5.7.8 All Material Identifications shall be evidenced in the Form F3P841AD01.
5.7.9 Deposit Filled Forms at the QA Department.

5.8 Contractor/ contract agreement

5.8.1 Service Contractors related to QC shall be approved and listed by QC and Purchase/Administration
Departments in F12P841AD01 on basis of Type of Service, Quality of Service Provided, Promptness
of Service and Terms of Payment.
5.8.2 Service Contractors for Maintenance of Electrical, Mechanical, Construction, Plumbing, Painting,
Waste Operations, Pest Control, Garden, etc. shall be approved by Maintenance and Administration
Departments on basis of Quality and Promptness of Service, and listed in F11P841AD01.
5.8.3 All Quality and GMP related Service Providers shall be Approved by QA Head on basis of Experience,
Capability, Status of the Provider in the particular Field of Operation and Terms and Conditions, and
listed in F9P841AD01. The list shall also contain Quality and Regulatory Service Providers and Key
Consultancy Providers Approved by Administration.
5.8.4 New vender on base of In House testing and COA if complies and accepted will be added in
provisional approved vender list F5P841AD01 with manual entry after successful complies of material
for 5 suppliers or for longer vender can be added in approved vender list after one year.

6.0 FORMAT FOR RECORDING:

F1P841AD01 - Purchase Order Form

F2P841AD01 - Registration Form for Suppliers/Service Providers
F3P841AD01 - Evaluation of Suppliers
F4P841AD01 - Vendor Approval Questionnaire For Active Raw Material
F5P841AD01 - Provisional Approval for RM and PM Suppliers
F6P841AD01 - Vendor Approval Questionnaire For PM and In Active Raw Material
F7P841AD01 - Incoming Raw Material Check List
F8P841AD01 - List of approved RM and PM Suppliers
F9P841AD01 - List of Approved Quality and Regulatory Service Providers
F10P841AD01 - List of Shippers for Export and Local Market
F11P841AD01 - List of Approved Maintenance & Other Service Providers.
F12P841AD01 - List of Approved Laboratory and QC Related Service Providers

QA/ADM. Prepared By Checked By Approved By

Name Ashwin K Patel (QA) Mitesh A. Shah (GM) Russell M Durham(Head QA)
Sign./Date
FOR RESTRICTED CIRCULATION ONLY
 DEEPAK CELLULOSE PRIVATE LIMITED Page
STANDARD OPERATING PROCEDURE 6 of 6
VENDOR EVALUATION AND PURCHASING PROCESS Doc. No. P841AD01
Title Ref: QM D441QA01- 8.4.1 Revision No. 07
Department QA/ADM/PUR Effective Date 01/11/2023
Copy Supersedes Rev No & Date 06; dated : 01/02/2022 Review Date 31/10/2025

7.0 ANNEXURE/REFERENCES : Nil

8.0 REVISION HISTORY:

Revision No. Effective Date Reason for Revision
00 20/12/2006 First issue P/DCPL/QA/343 ; DCPL/QA/315 ; P/DCPL/QA/337/02/20/12/2006
01 17/08/2012 i)-changed ‘QC’ to ‘QA’ and ‘Director/s’ instead of ‘technical/marketing’ ; ii) added 6
02 01/04/2014 format and complete procedure style for IPEC PQG GMP requirement. New doc for records.
03 01/04/2018 Doc.no.change as per ISO9001-2015
04 29/01/2019 Doc No changed as per EXCiPACT; modified 5.7 & Frequency of Vendor Questionnaires added
05 15/07/2021 Point add 5.8, responsibilities change 4.0
06 01/02/2022 Approved vendor name and address added for supplier and manufacturer,Format No. change
Approved Vendor, Approved Quality and Regulatory Service Providers, Transporter for Export and Local
07 01/11/2023
Market, Maintenance & Other Service Providers.updated.

QA/ADM. Prepared By Checked By Approved By

Name Ashwin K Patel (QA) Mitesh A. Shah (GM) Russell M Durham(Head QA)
Sign./Date
FOR RESTRICTED CIRCULATION ONLY