MDI STANDARD OPERATING PROCEDURE Page 1 of 18

Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011

PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

REVISION DATE: 3 years after effective date or when needed.

TABLE OF CONTENTS

1- PURPOSE……………………………………………………………………………………………2

2- SCOPE……………………………………………………………………….……………………….2

3- REFERENCES………………………………………………………………………………….…..2

4- ABBREVIATIONS AND DEFINITIONS……………………………………………..…….2

5- PROCEDURE AND RESPONSIBILITIES………………………………………….………3

6- RESPONSIBILITY OF PERSONAL …………………………………………….………….18

7- DOCUMENT REVISIONS……………………………………………………………....….18
MDI STANDARD OPERATING PROCEDURE Page 2 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

1- PURPOSE:

To provide a system to evaluate suppliers who supply raw packaging

material conforming to specified requirements.

2- SCOPE:

This SOP applies to evaluate supplier who supply material to our

company.

3- REFERENCES:

AQM ISO 9001.

4- ABBREVIATIONS AND DEFINITIONS:

(SOP) Standard Operating Procedures.

(GMP) Good Manufacturing Process .

(AQM) Arab Quality Maker.

(MDI) Modern Drugs Industries Company.

(ISO) International Standard Organization.

(QA) Quality Assurance.

(QC) Quality Control

Material:- raw material and packaging material (label, carton, leaflet,

aluminum foil, tubes, etc.)
MDI STANDARD OPERATING PROCEDURE Page 3 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

5- PROCEDURE AND RESPONSIBILITIES:

A- All approved suppliers names are recorded in a list the list may be
approved by the commercial and QA Managers (schedule no-10).

B- procurement officer evaluated the suppliers according to the

following.

* Conformity of the material with the required specification.

* Conformity of the material with the required special condition.
* Delivery time commitment.
* Payment facilities.
* Ease of handling.

C- Procurement officer evaluated performance of the suppliers for each

contract according to the content condition of the contract and this
evaluation to be approved by commercial Manager according to the
following scores (schedule no-11).

0 50 Weak.

51 60 Medium.

61 70 Accepted.

71 80 Accepted good.

81 90 Accepted very good.

91 100 Accepted Excellent.

MDI STANDARD OPERATING PROCEDURE Page 4 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

D- Procurement officer follow up performance suppliers every year

periodically from the review of evaluation & follow up to the
performance of suppliers (schedule no-11).

E- Cancel the suppliers from the list of approved suppliers (schedule no-
11). After more than warn without commitment of suppliers with these
warn.

F- New suppliers may be added in the list of approved suppliers by the

same procedure of follow up & evaluation.

G- In stats of importing of buying new material we needed from the

suppliers the following.

* Material safety Data sheet.

H- The suppliers to be committed by the special condition in
transporting come special material like (temp, protect the material from
direct light, humidity…etc.).

I- It is primary responsibility of the purchasing department to establish

and qualify a supplier.

J- Wherever possible, purchasing should be from the manufacturer

rather through an agent. When an agent is used and if the original
manufacturer is not identified containers additional controls must be
instituted.

K- Written specification shall be established in co-operation with

production and Q.C. dept.

L- Purchase order shall include the specification or refer to a

specification in the documents provided to supplier.
MDI STANDARD OPERATING PROCEDURE Page 5 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

M- New vendor shall be required to meet the same specification as

older vendors. They will also be required to supply appropriate sample
and documentation to Q.C prior to acceptance as an approved vendor.

N- For active ingredients the supplier is to be audited initially and at

periodic intervals. There after it is only to ensure that adequate process
controls are in place for consistency of production and that the supplier
meets GMP requirements. The need to audit and it is frequency, will be
deter mind by the suppliers past quality, history and nature of its
suppliers. The supplier is certificate of analysis should be received for
each batch of raw material received it is to be reviewed by Q.C. The
performance of key suppliers should be monitored via trending to test
data and reject/rework. Corrective action must be taken for
unsatisfactory supplier performance.

O- It is the responsibility of purchasing department to keep the

approved vendor list current.

P- Approved vendor list contains

* Vendor is name.
* Product supplied by vendor.
*specification approval date by QA., QC., production and purchasing
department.
* vendor approval date.
* Comments for additional information.
 MDI STANDARD OPERATING PROCEDURE Page 6 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.1

Questionnaire assessed the supplier companies

Company Name :-
Name of owner company :-
Name of the authorized :-
Score or degree of evaluation :-

Calculated Planning & Stores chemical & Q.C & lab Management
NO Question of evaluation Accounts Notice
ratio score commercial office packaging rotary legal section
Legal archives of the company (Articles
1 of association certificate of 10 %
incorporation
Dose the company have representative
2 to deliver the materials & receipt of 10 %
Duse to contracts
The cooperation of the company with
3 the department concerned 10 %
(receiving & delivery)
The commitment of the supplier within
4 10 %
the period specified for processing
The commitment of the supplier within
5 the period specified for 10 %
receipt of receivables
 MDI STANDARD OPERATING PROCEDURE Page 7 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.1

Questionnaire assessed the supplier companies

Calculated Planning & Stores chemical & Q.C & lab Management
NO Question of evaluation Accounts Notice
ratio score commercial office packaging rotary legal section
6 Quantity accepted & quantity refused 10 %
The interest of suppliers by packaging
7 10 %
& cartonning of material
8 Safty of transportations 10 %
9 Comply with the recommendation 10 %
10 Existence certificate of origin 10 %
11 Location/site of the company
12 Method of communication
Total Score ( ) % ( )% ( )% ( )% ( )% ( )% ( )%

Stores Official Manager of Planning Commercial GMP & ISO

Legal officer
Chemical/packaging Accounts Q.C & Lab Manager Manager Manager

GENERAL MANAGER
MDI STANDARD OPERATING PROCEDURE Page 8 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.2

From list of customers name

- Name of customers accredited
- Name of restricted customers

NO Company name Name of outhori3ed Notice

Planning Manager Commercial Manager GENERAL MANAGER

MDI STANDARD OPERATING PROCEDURE Page 9 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.3

Purchase order
NO :-
Date:-

Quantity Required
NO Article Name Specifications Estimated Cost
NO. Writing

Department concerned to develop specification.

Name :-
Signature:-

Financial
Head of Planning Commercial General
Manager
Stores Manager Manager Manager
MDI STANDARD OPERATING PROCEDURE Page 10 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.4

Document Of Materials Delivery

To :- Material Story:-
Order NO.:-
Date of purchase order:-

Materials Name Quantity

NO Unit Unit Price Total Price Notice
& Specification NO. Writing

Representative of Responsible for Planning

Store Keeper
procurement committee setting specification Manager

Copy of it to:
Accounts
Store keeper
Control of inventories
MDI STANDARD OPERATING PROCEDURE Page 11 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.5

Report Of The Committee Open The Pox

Tender NO. :- Date:-
Closing Date:- Date of opening:-
Number of preventative offers:-
Number of companies received the offers:-

Name of the supplier Matching or comply offers with the

NO Notice
companies terms or condition of tender or missing

Committee decision ………………………………………………………………………………

………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

Member Member Member chair man

Of the committee
MDI STANDARD OPERATING PROCEDURE Page 12 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.6

Report Of Analysis Committee

Tender NO. and date :-
Date of analysis :-
Name of Article :-

Name of Period for

NO Quantity Origin Price Notice
companies delivery

Recommendation of the committee ………………………………………………….……

……………………………………………..…………………………......…………………………………
………………………………………………………………………………………………………………..

Member Member Member chair man

Of the committee
MDI STANDARD OPERATING PROCEDURE Page 13 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.7

Exchange Entitlements Supplier

No. :-
Date :-
Mr. director general esquire.
Subject/Final report for disbursement of benefits processed.
Contract No. :- ……………………….. Tender No. :- …………………….
We include below information & observation relating to the processing
of materials (Articles) by supplier. We ask you kindly to take the
necessary duse on the disbursement of the final light of remarks in
accordance with asset appreciation

Quantity Quantity
Price Total benefit
NO Article name according to the Actually Notice
Widget/K Price
contract received

Grand total

General note:-
1- No. of certificate of analysis.
2- Delay penal ties.
3- Possibility of primary re-insurance.
4- other observations.
 MDI STANDARD OPERATING PROCEDURE Page 14 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
. ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.8

Records Follow-Up Of Tender And Contracts

No. & date of No. & date of Expiry date of Content of the
NO Company Name Notice
tender contract contract contract
 MDI STANDARD OPERATING PROCEDURE Page 15 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.9

Records Of Movement Material In Ware Houses (Stores)

Name of store :- Sequence:-

Material name :- Min. balance :-
Serial or code No. :- Standard unit :-

Document No. Date Statement Batch No. Incoming Issued Balance Notice
 MDI STANDARD OPERATING PROCEDURE Page 16 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.10

List Of Approved Suppliers

No. & date of No. & date of Expiry date of Content of the
NO Company Name Notice
tender contract contract contract

Procurement officer Commercial manager

Name :- Name :-
Signature : Signature :-
 MDI STANDARD OPERATING PROCEDURE Page 17 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

Schedule NO.11

Evaluation & Follow-Up Suppliers Performance

Supplier Name :- Evaluation period:- from……………to…………………..

No. & date of Conformity with required Delivery time Payment Ease of hand Result of
NO Article Type
purchase order specifications 50% commitment 20% facilities 20% ling 10% evaluation

As a result of the find evaluation

Procurement officer Commercial manager
Name :- Name :-
MDI STANDARD OPERATING PROCEDURE Page 18 of 18
Title: SUPPLIER APPROVAL SOP N°……/02 Effective date: \ \2011
PREPARED BY: REVIEWED BY: REVIEWED BY: APPROVED BY:
ISO & GMP dept. Planning manager Brand or commercial Brand or commercial
manager manager
DATE: 01\11\2011 DATE: 02\14\2011 DATE: 02\14\2011 DATE: 02\14\2011

6- RESPONSIBILITY OF PERSONAL:

The persons responsible for the approval are stated in the below table:

Department or personnel Responsibility

Approved the specification of
QC. & AQ.
material
Approved the evaluation & follow-up.
Commercial Manager
Suppliers
Procurement Officer Design approval

7- DOCUMENT REVISIONS:

No. Section Pages Initials/Date

END OF DOCUMENT