Procedure for Qualification of Vendors for Raw Material and Packaging Materials

Procedure for inclusion of vendor in approved vendor list (Raw materials)

New vendors must be qualified and approved by QA department before the regular supply of raw materials in the following manner.

1. Purchase department will locate the new vendor and find out the details of products manufactured/ supplied by them. In case of existing materials, Purchase department will provide our specification to the new vendor.
2. Purchase department will submit the samples to QA department or R&D department for evaluation as per specifications.
3. Samples from 3 consecutive lots/ batches of active ingredient should be procured as a pre-shipment sample along with the certificate of analysis. For active as well as excipients, Assurance / Declaration of compliance with TSE / BSE requirement or material is of vegetable origin shall be taken from the manufacturer.
4. Quality Assurance or R&D department should analyze the sample.
5. After a complete analysis of the sample, the analytical report along with the comments of QA department shall be sent to Purchase department. The vendor will be included in the temporary approved vendor list if the samples are meeting the specifications. The new addition to the list is entered manually and approved by Head QA & QC till the list is amended.

6. Purchase department after studying the comments of QA department shall inform the supplier for the supply of the material manufactured by them.
7. An audit is performed by a representative of Purchase department, QA department.
a) Active Raw Material / Excipients vendor audit report shall be prepared.
b) A supplier questionnaire is sent to suppliers.
c) However the visit and audit of the vendor shall not be considered as an approving criterion and based on the previous history, background and quality trial lots supplied by the supplier, the vendor may be included in approved vendor list.
8. Purchase department shall carefully study the quality aspect and also the quantity and financial aspects of the vendor, they are as follows;
a) The capability of the vendor to supply the required material within the period.
b) Delivery schedule in order not to affect the production cycle.
c) The rates quoted by the vendor whether they are competitive with respect to other vendors without compromising the quality aspects.
9. Based on the product compliance and assessment, further procurement of active raw material should be continued. On ensuring compliance with specifications the vendor shall be included in permanent vendor’s list during the update of the list.
10. All the suppliers evaluated by R&D department on the basis of process/ product development parameters shall be considered as temporary vendors and will be included in temporary approved vendor list. Based on the commercial production supply, they will be transferred to approved vendor list and shall be considered as permanent approved vendors.
11. Vendors recommended by R&D having drug master file number shall be included as temporary vendors and based on the performance of commercial supply for production batches will be transferred to the approved vendor list.
12. Vendors approved by the product license holder or contract giver will be listed separately as approved for product license holder products.
Related: SOP for Qualification of Vendors

Procedure for inclusion of vendor in approved vendor list (Packaging material)

New vendors must be qualified and approved by QA department before a regular supply of packaging materials in the following manner.
1. Purchase department will locate the new vendor and find out the details of products manufactured/ supplied by them. In case of existing materials, Purchase department will provide our specification to the new vendor.
2. For printed and primary packaging materials, vendor audit is performed by a representative of Purchase department, QA department.
3. Samples of printed packaging materials if necessary will be submitted to QA department for evaluation.
4. Purchase department after studying the comments of QA department shall inform the supplier for the supply of the material manufactured by them.
5. Purchase department shall carefully study the quality aspect and also the quantity and financial aspects of the vendor, they are as follows;
a) The capability of the vendor to supply the required material within the period.
b) Delivery schedule in order not to affect the production cycle.
c) The rates quoted by the vendor whether they are competitive with respect to other vendors without compromising the quality aspects.
6. Based on the product compliance and assessment, further procurement of packaging material should be continued. On ensuring compliance with specifications the vendor shall be included in permanent vendor’s list during the update of the list.
7. All the suppliers evaluated by R&D department on the basis of process/ product development parameters shall be considered as temporary vendors and will be included in temporary approved vendor list. Based on the commercial production supply, they will be transferred to approved vendor list and shall be considered as permanent approved vendors.

Procedure for the exclusion of vendor from the approved vendor list

1. The vendor shall be disqualified and removed from the approved vendor’s list for the following reasons :
a) If a lot does not comply with the specification with respect to critical tests then the vendor shall be disqualified. The vendor shall be qualified again for further evaluation and investigation.
b) If a lot does not comply with the specification with respect to minor tests then the vendor shall be disqualified if it is observed for 3 consecutive lots.
c) 3 out of 10 lots failed to comply the specification in a specified period under review.
d) The delivery schedule is not met for 40% supplies.
2. The rates mentioned in Purchase Order differs than the rates mentioned in delivery challan and invoice.

Corrective and preventive action

The vendor, who has been excluded from the approved vendor’s list, may be included again by taking following corrective and preventive actions;
1. The vendor shall be made aware of the reasons for his exclusion and shall be asked to explain.
2. Head Purchase and Head QA&QC shall conduct facility audit of the vendor in order to ensure that quality system exists in the organization.
3. Carry out the discussion on other non-quality issues like delivery schedule and rate, etc.
4. After satisfactory compliance with all above points, the vendor shall be included in Temporary Vendor List.

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