sop for vendor approval of raw materials

sop for vendor approval of raw materials

1.0 OBJECTIVE: : 

1.1 The objective of this SOP is:
1.1.1. To describe a procedure to assess the vendors who can manufacture and supply materials of consistent quality and quantity and at right time

2.0 RESPONSIBILITY:

2.1 The Head – Quality Assurance shall be:
2.1.1. Responsible for auditing the vendor for cGMP Compliance periodically in co-ordination with Head – Materials.
2.1.2. Responsible for preparing the vendor audit report and further necessary actions.

3.0 ACCOUNTABILITY

Head – Technical Operations

4.0 PROCEDURE:

4.1 Methodology:

4.1.1 All existing Vendors who have already been approved by our (Mother Plant) and Research & Development shall continue as Approved Vendor.
4.1.2 Head – Materials shall be responsible for initiating the need for New vendors.
4.1.3 New Vendors shall be assessed for their technical capabilities by Quality Assurance and Materials Department
4.1.4 Head – Quality Assurance shall recommend approval of a New Vendor based on their overall technical capabilities and quality management system which can be accessed by Vendor audit for GMP compliances & documented as per the check list as per Annexure – 1.

4.1.5 Head – Materials shall be responsible to negotiate on commercial aspects viz. delivery schedule, packing, price etc.
4.1.6 The over all coordination of the activity shall be performed by Head – Technical Operations and Head – Materials and he shall be responsible for approval of New Vendor on their overall technical capabilities and financial conditions.
4.1.7 The current vendor shall continue to remain approved, on the basis of their past performance, and re-approval and is if shall be done once in 2 year to continue as approved vendor for API as well as Raw Material.
4.1.8 The Head Quality Assurance or Head –Technical Operations and Head – Materials shall audit the facility of the concerned vendor and shall record all information given in checklist for ready reference as per Annexure – 1.
4.1.9 Irrespective of any amount of urgency, receipt of duly filled checklist and its review will be emphasized before placing the trial order for new vendor.
4.1.10 All the specifications of materials shall be provided to vendor / supplier by the purchase officer of materials department.
4.1.11 Commercial negotiations shall be organized by Head – Materials in co-ordination with Head – Technical Operations

4.2 Assessment of the pre-purchase samples:

4.2.1 Based on the agreed specification and technical discussion, the vendor shall arrange to forward pre-purchase samples of 3 independent batches to materials department along with their certificates of analysis.
4.2.2 Materials Department shall send the Pre-purchased sample to Research & Development (R&D) along with Certificate of Analysis for complete evaluation.
4.2.3 R & D shall analyse the sample as per specification, if any clarification is needed, then may contact the vendor for Standard Test procedure or Working Standard etc.
4.2.4 Sample performance shall be finally evaluated by Head – R&D, based on the COA. In specific situation, such as suitability through stability evaluation or trial is foreseen the, the approval of vendor shall await, till the same is completed.

4.2.5 R&D shall convey the finding to location Quality Assurance Head and Head – Technical Operations on the basis, which Quality Assurance shall plan and carry out vendor audit to confirm the compliance level of cGMP at vendor audit report and data submitted by R & D.
4.2.6 Head – Quality Assurance or Head – Technical Operations and Head – Materials shall conduct the cGMP Audit.
4.2.7 After Audit, audit report shall be forwarded to Head – Technical Operations.
4.2.8 Head – Technical Operations shall take the decision for approval or rejection of the basis of vendor audit report and data submitted by R & D.
4.2.9 If the vendor is approved, the vendor list shall be updated and the Master Copy shall be remained with Quality Assurance, and Certified copy shall be issued to Warehouse, Materials and R&D.
4.2.10 During annual product review if any adverse observation was detected due to any of the raw materials then the vendor shall be identified and his approval is canceled. The vendor is then enrolled as Black listed Vendor.
4.2.11 Annual Plan for Vendor Audit shall be prepared in advance and inspection shall be done accordingly.
4.2.12 Approved vendor shall be re-evaluated for compliance of cGMP with in 2 year of approval or earlier base on the trend of rejections for a particular vendor.

5.0 REASON FOR REVISION:

This SOP is revised in order to be more effective in Vendor approval procedure.

6.0 Training:

Trainer — Head – Technical Operations
Trainee — All Departmental Heads
Period — One day

7.0 DISTRIBUTION:

Certified Copy No. 1 – Head Of Department Quality control
Certified Copy No. 2 – Head Of Department – Materials
Certified Copy No. 3 – Head Of Department – Purchase
Certified Copy No. 4 – Head – Plant Operations
Reference Copy No. 5 – File Copy in Vendor Approval File
Original Copy – QUALITY ASSURANCE

8.0 ANNEXURES:

Annexure – 1 : Vendor Audit Questionnaire.

9.0 REFERENCE:

In-house

ANNEXURE  – 1

CHECKLIST OF QUALITY EVALUATION OF THE VENDOR

 

NAME OF THE VENDOR      : ——————————————————————

 

LOCATION OF THE PLANT: ——————————————————————

 

PRODUCTS OFFERED          : ——————————————————————

 

 

 

A.      ORGANISATION

 

ORGANOGRAM

 

Plant Yes/No
QA/QC Yes/No
CONTACTED PERSON DURING VISIT
Managing Director/ Technical Director Yes/No
Site in charge/Plant Manager Yes/No
QA Manager/ QC Manager Yes/No
Production/ Packaging Manager Yes/No

Sales Manager

Yes/No

 

B.      FACILITIES

 

Plant layout Acceptable / Not acceptable
Maintenance of the Premises Acceptable / Not acceptable
General house keeping Acceptable / Not acceptable
Scope for expansion Yes/No
Plant Life 0-5, 5-10, > 10Years
Is the Facility dedicated Yes/No
Is the Manufacturing area is adequately Ventilated Yes/No

 

 

Is the separate area for sampling of Raw Material Available Yes/No
Is the manufacturing/ Packing area provided with adequate light Yes/No
Are area available for Sterility (for sterile Preparations) intermediates and finished products Yes/No
Are balances and measuring equipment’s of the appropriate range available Yes/No
Are fixed pipe works labeled to indicate the Contents and directive for flow Yes/No
Is pest and rodent Control program is available Yes/No

 

Rating

 

1 2 3 4 5

 

( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)

 

  1. QUALITY ASSURANCE SYSTEM

 

Do they have approved specification Yes/No
 

Do they have approved STPs

Yes/No
 
Do they have approved SOPs Yes/No
Do they have stability Programs Yes/No
Do they have formal training programs   For  Production and QA  

Yes/No

   
Do they have written schedule for training Yes/No
Do they have written calibration schedule of the analytical instruments  

Yes/No

Do they have quality Assurance system for the supplier  

Yes/No

Do they have standard sampling plan Yes/No

  

Do they have proper storage facility Yes/No

Do they have proper system to check inputs

Yes/No
Do they received material with certificate of analysis Yes/No
 

Do they posses adequate testing facility

Yes/No
 

Do they have competent and adequate staff

Yes/No
 

Is corrective action taken for defect identification

Yes/No
 
Does an authorized manufacturing formula exist Yes/No
 
Are processing instruction provided in details Yes/No
Is a batch processing record available for each batch processed  

Yes/No

Are dates and times are recorded for various stage of operation  

Yes/No

Are critical steps are cross verified Yes/No
Rating
1 2 3 4 5

 

 

( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)

 

  1. MATERIAL CONTROL

 

Are Released/Rejected/ Under test materials segregated properly Yes/No
Is rejected material controlled adequately destruction in case of PMS – printed material  

Yes/No

Are Material handled properly to prevent damages Yes/No
Do they have secured, lockable facilities to control narcotic drugs and labels  

Yes/No

 

Are Material properly segregated to prevent mix-ups Yes/No
Do all the containers have the proper label for product, batch no. Qty, Mfg, Exp, Date etc.  

 

Yes/No

Are receiving procedure adequate Yes/No
Are adequate facilities available to store the material at their premises  

Yes/No

Ware house of Incoming material Adequate/ Inadequate
Ware house of outgoing material Adequate/ Inadequate
Insurance facilities Adequate/ Inadequate
Transport facilities for receiving materials Adequate/ Inadequate
Transport facilities for dispatching materials Adequate/ Inadequate
Rating
1 2 3 4 5

 

( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)

 

E.       MANUFACTURING/ PACKAGING

 

Are manufacturing process adequate to produce quality components (written/ Approved document) Yes/No
Are line clearance concept adopted at the time of change over of product to prevent batch mix-ups/ Product mix – ups  

 

Yes/No

Do the personnel in manufacturing have the awareness towards the quality  

Yes/No

Do production personnel follow the working disciplines as per c GMP requirements (Head gear, Safety goggles, Hand gloves, Nose masks ets.)  

 

Yes/No

   
Are waste material kept separately in proper container Yes/No
Are equipment’s maintained/calibrated as per schedule Yes/No

 

Are in process checks adequate to ensure consistency in quality

 

Yes/No

Are proper accountability done after completion of the batch  

Yes/No

Are adequate precaution exercised during packging to prevent mix-ups  

Yes/No

Are excess coded packaging material (labels/ Cartons etc.) destroyed after completion of the batch  

Yes/No

Are documentation adequate during manufacturing and packaging to ensure the Quality  

Yes/No

In handling of material and product performed in accordance with written procedures  

Yes/No

Are all manufacturing process clearly defined

Yes/No

Whether systems exists for process/product/equipment status indication system

 

Yes/No

Are there any checks on yields to ensure that they are not out side acceptable limits

 

Yes/No

Are air locks or air extraction system provided to avoid contamination in necessary

 

Yes/No

 

RATING
1 2 3 4 5

 

( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)

 

 

  1. RELIABILITY/ CUSTOMER SATISFACTION

 

Is there formal system to investigate rejection/ market complaints  

Yes/No

Is there proper system to report failures Yes/No
Is there formal system to provide feed back to customers  

Yes/No

 

Is there any list of other customer’s available Yes/No
Does vendor complete entire work or take the help of sub – contractor  

Yes/No

Are they capable to adhere delivery schedule Yes/No
Do they have proper record on feed back on quality of their product from other customers  

Yes/No

RATING
1 2 3 4 5

 

( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)

 

  1. FINANCIAL RANKING (CREDIBILITY IN MARKET)

 

What is the approximate value of inventory held           Rs. _________

 

What are the major items for which inventory held    Class A____%, B______%

 

What is approximate annual turnover of sales               Rs. _________.

 

Study of financial terms:

 

  • Documents against acceptance
  • L/c sight or clean credit
  • Documents through bank
  • Performa Purchase
  • Co-acceptance scheme
  • Direct suppliers

 

Is he open if we approach his bankers to check his financial rating

Yes/No
What is the last year approximate gross profit Rs._____

 

Any future plans for expansion / diversification  

Yes/No

 

RATING
1 2 3 4 5

 

( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)

 

 

  1. COMMERCIAL OBSERVATIONS

 

Does he prefer long term contract? Order backed supplies

 

Does he prefer delivery FOR Sight /Works

 

Discount structure

 

Can he supply through DAMAN/ TAX/ TAX FREE ZONE

 

I.  RECORDS KEEPING Adequate/ Inadequate
J. COMPUTERISATION Adequate/ Inadequate/Nil
K. SCRAP DISPOSAL PROCEDURE
Adequate/ Inadequate
L. LABOUR MANAGEMENT RELATION Adequate/ Inadequate
M. GENERAL OBSERVATIONS
How would you rate the morale of the total Organization Poor/ High/ Very high
How would you rate the progressiveness and competence of supplier’s management Poor/ High/ Very high
How would you rate the technical capability of the vendor Poor/ High/ Very high
How would you rate the financial capability of the supplier Poor/ High/ Very high
How would you rate the commitment to Quality/ performance of the material from supplier Poor/ High/ Very high
How would you rate the commitment to timely delivery of the material from supplier Poor/ High/ Very high
 
RATING
1 2 3 4 5

 

( 1-Poor, 2-4- Opportunity to Improve, 5- Very good)

 

 

  1. CONCLUSION

 

Remarks : ________________________________________________________________________________________________________________________________________________________________________________________________

 

 

Date SIGNATURE :
  DESIGNATION:

Leave a Comment

error: Content is protected !!