Saturday, November 20, 2010

Instruction for Vendor Approval / Qualification.

1.0             Purpose    :        To provide instruction for Vendor approval / qualification.

2.0            Objective   :       To provide a documented procedure for Vendor approval / qualification.

3.0              Scope       :          This procedure is applicable for Vendor approval / qualification.

4.0         Responsibility  :
·        Quality Control
·        Quality Assurance
·        Purchase Department

5.0       Procedure :
·        Vendors of raw materials and packaging materials shall be categorized as below:
·        Critical Vendors.
Ø      All vendors who supply active raw materials, inactive raw materials, printed packaging materials, primary packaging materials are classified as critical vendors.
·        Non-critical Vendors.
Ø      Suppliers of materials, which do not have direct / impact on product quality. These vendors shall be classified as non-critical vendor and approval shall be based on routine compliances to the specifications.
Ø      Ask the vendor to submit samples of three consecutive batches of the material for testing.
Ø      Ask the vendor to fill and submit vendor / contract registration form for official record.
Ø      Ask quality control department, to carry out testing and report the analytical findings to the material department.
Ø      On satisfactory conformance with the specification, material department sends the supplier a questionnaire to the vendor in order to get aware of his systems and mode of working.
Ø      Prepare a cross-functional audit that makes a visit to the vendor’s facility on a predetermined date and evaluate his facility.
Ø      Teams prepare a vendor audit report with additional information like, GMP, WHO etc. certification and send to QA department.
Ø      Upon receipt of the filled questionnaire, QA analyzes it and marks off the vendor to the approved vendor list upon satisfaction.
Ø      The vendor certificate of analysis should contain, name and address of vendor, date of manufacturing and or retest / expiry date of the batch, test results along with specification, and authorized signature.
Ø      The processing of new vendor of recipient should be critically monitored. Any adverse observation during the period of stability study shall be brought to notice immediately to production department, purchase department and quality assurance.
·        Vendors are evaluated as per followings:
Ø      The vendors are evaluated on the basis of quality of material and timely supply.
Ø      Prepare evaluation report as a part of the trend analysis.
Ø      In case any critical non-conformance observed during the periodical evaluation of vendor, which has an adverse effect of the quality of product, seizing the vendor in inventory system shall stop further procurement.
Ø      Revalidation of the vendor to be performed in case of adverse effect (e.g. material failure) or after every two years for critical vendors on regular basis.
6.0      Reference Document  :
v     Vendor registration form
v     Vendor audit report
v     Vendor Questionnaire

7.0      Abbreviations  :
·        QA   = Quality Assurance department
·        SOP = Standard Operating Procedure
·        QC = Quality Control

8.0      Copies to  Distribution Sites
·        QA
·        Production
·        Stores
·        QC







                                           Vendor registration form
1.
Name of Vendor
:



2.
Nature of Business
: Manufacturer / Supplier /Distributor Or Other
3.
Nature of Company
: Proprietary / Partnership / Private Limited / Public Limited



4.
Name of Directors
:



5.
Type of Industry

:

Address
:

Office
:




Site
:



6.
Contact Persons
:

Sales
:

Quality Assurance
:

Quality Control
:




Phone
:

Fax
:

Email
:



7.
Annual Turnover during last 3 Years
:









CERTIFICATION AND AUDITS

8.
Manufacturing Licence / Wholesale dealer Licence
:No.:


:Dated:


:Validity:



9.
GMP Certificate
:No.:


:Dated:


:Validity:



10.
Certificate of Suitability
:No.:


:Dated:


:Validity:



11.
Approval from any regulatory body? FDA, MHRA, EMEA etc. Quota date / reference of last inspection
:

SOCIAL ASSESSMENT

12.
No. of Personnel Working
:
Production
Quality Control
Marketing and sales
Administration



(Enclose Organogram)



13.   
No. of Contractual Workers
:


(If outsourced any)



14.   
Daily Working Hours
:



15.   
No. of Holidays /Year
:



16.   
Disciplinary Act Maintained
:



17.   
Are Separate Refreshment Areas Provided?
:



18.   
Are Extra Incentive Given to Employees?
:



19.   
Are Personnel Trained in skilled jobs?
:



20.   
Is Grievance Procedure Followed?
:



21.   
Are Safety Measures Followed?
:



22.   
Are Environmental Risk Factors Considered?


MANUFACTURING

23.             
Approved Authority
:1) Indian Food and Drug Administration
2) MHRA
3) USFDA
4) Any Other

24.             
Your facility audited by any external agencies/ customer (Give details)




25.             
List of product manufactured by you (Attach Annexure)




26.             
Surrounding type of industries on the four sides of the site:




27.             
Source of Water





28.             
Test protocols of water




29.             
Calibration program
Yes / No



30.             
Training Program / Records
Yes / No



31.             
Deviation Handling System
Yes / No



32.             
In case you are using same equipments for different products do you have?

a)         
Sufficient cleaning procedure.

b)        
Are they validated?
Yes / No
c)         
Do you perform cleaning validation?
Yes / No
d)        
How do you prevent cross contamination?




33.             
Do you maintain following documents

a)         
Batch Manufacturing record
Yes / No
b)        
Specification of R.M & F.P
Yes / No
c)         
Test Methods
Yes / No
d)        
Master manufacturing and control record
Yes / No
e)         
SOPs for various activities during the process /cleaning / change over document etc.
Yes / No
f)          
Is there change control system?
Yes / No
g)         
Is there a system to inform your buyer for any changes of in process / equipments/ specification?
Yes / No
h)         
Are there records for testing at different stages of manufacturing and finished products maintained?
Yes / No
i)           
Are the record archived for easy retrieval?
Yes / No
j)          
Is there a complaint handling system?
Yes / No
k)        
Is there a standard operating for handling retesting and failure?
Yes / No

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