Sop for Procedure for Vendor Qualification
1.0 OBJECTIVE :
To establish procedure for evaluation, approval and disqualification of vendors for procurement of raw materials and packaging materials required for manufacturing and packing of finished products respectively.
2.0. SCOPE :
2.1 This procedure is applicable to all written or oral market complaints (regarding finished product manufactured received either from customers, regulatory authorities or distribution points.
3.0 RESPONSIBILITY :
3.1 Head Production/ Head QA
4.0 ACCOUNTABILITY :
QA Head
5.0. PROCEDURE :
5.1.1 Whenever there is a need for introducing new vendor, purchase department shall identify the manufacturer for the desired raw or packaging materials and arrange for the following from the vendor. Information from the Manufacturer as per Annexure I.
5.1.2 Filled Questionnaire for manufacturers of raw materials’ (Annexure II)
or Filled `Questionnaire for manufacturers of packaging materials’ (Annexure III).
5.1.3 Raw material samples for evaluation (sufficient for complete analysis) and reference/working
standards of active and impurities (required for testing) shall be collected from vendor along with their
three consecutive batches Certificate of Analysis.
5.2 The samples shall be forwarded to Quality assurance for analysis. QA shall evaluate the information collected
from Vendor as per Annexure-I and corresponding filled questionnaire.
5.3 Quality Control shall carry out testing of samples as per respective specification and convey the results to
Quality Assurance using New vendor evaluation report.
5.4 Based on the review of the filled Questionnaire, Information from Vendor and QC analysis results,
Plant Head-QA, shall recommend –
5.4.1 Requirements of Facility Audit
5.4.2 Approving the Vendor
5.4.3 Rejecting the vendor
5.5 Based on satisfactory sample evaluation, questionnaire and regulatory approvals
(for the products and facilities under review) Vendor may be approved by QA.
5.6 For any new requirement, from the already approved Vendor, the approval shall be given based on
the review of product related information, questionnaire and sample evaluation.
5.7 Based on QA review, if required the audit of the facility shall be planned and conducted to assess
the Quality system of the vendor based on the applicable regulatory requirements for the
product(s) under scope of audit. Audit team shall be comprising of members from QA and/or manufacturing/Purchase.
5.8 All the observations made during the audit shall be communicated to the vendor as audit report. On receipt
of satisfactory compliance report from the vendor, the Approval status of the facility shall be
communicated to the vendor and the purchase department.
5.9 Approval of new vendor shall be communicated to all departments; QC, Purchase and Warehouse by QA and
maintain the details of approved vendor as per the format attached as Annexure IV. The approved vendors list
for Raw materials and Packing materials shall be updated at the frequency of six months and circulated to
the Warehouse department and Quality Control department.
5.10 In between the updation of Approved vendor list as per the frequency the details of new approved vendor shall be
entered manually in the Vendor list and updated as per the frequency. Whenever the list is updated the revision
number of the vendor list shall be changed. (Starting from ‘00’ and thereby in sequence for further revisions).
5.11 Whenever the material from new source of vendor is received, the warehouse personnel shall intimate
the same to Quality Assurance personnel.
5.12 Based on the intimation, the Quality Assurance personnel shall raise the change control and
the Head QA shall enter his comments regarding the number of batches required for Process validation or
stability study, if required and accordingly the change control shall be implemented.
5.13 Periodic evaluation of Approved Vendor:
5.21.1 Vendor shall be evaluated annually for their performance based on the following criteria:
Quality score of “100” for every Approved supplies.
Quality score of “0” for every Rejected supplies.
Quality score of “50” for partly or conditionally Approved supplies.
5.21.2 The vendor shall be continued to be in the “Approved vendor list” if the
average Quality
score of the ratings is NLT 75.
5.21.3 If the average Quality score of the ratings is less than 75, then vendor shall be
communicated for the poor trend and necessary corrective actions taken
shall be evaluated.
5.21.4 On satisfactory findings of corrective actions, vendor shall be continued to be in the
“Approved vendor list”. In case of discrepancy, vendor shall be treated as new vendor for
further requirements and accordingly the approved vendor list shall be updated.
6.0. ABBREVIATION:
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | SOP | Standard Operating Procedure |
| 2.0 | QA | Quality Assurance department |
| 3.0 | QC | Quality Control |
| 4.0 | TSE | Transmissible Spongiform Encephalopathy |
| 5.0 | BSE | Bovine Spongiform Encephalopathy |
| 6.0 | NLT | Not Less than |
| 7.0 | API | Active Pharmaceutical ingredient |
7.0. ATTACHMENTS (ANNEXES) :
Annex I : Information required from Manufacturer
Annex II : Questionnaire for Raw material manufacturer
Annex III : Questionnaire for Packing material manufacturer
Annex IV : Approved Vendor List format
8.0. REFERENCE:
Schedule M