SOP for Qualification of Vendors

1.0 OBJECTIVE:

SOP for the qualification of vendors for the Packaging materials.

2.0 SCOPE:

This SOP shall be applicable for all the incoming Packaging materials used for
Own & Contract manufacturing sites.

5.0 PROCEDURE:

5.5 Procedure for Inclusion of Vendor in Approved Vendor List (Packaging

Materials)

5.5.1 New vendors must be qualified and approved by Packaging engineer before regular supply
of packaging materials.
5.5.2 Purchase department shall locate the new vendor and find out the details of products
manufactured / supplied by them. In case of existing materials, Purchase department shall
provide specification to the new vendor.
5.5.3 For printed and primary packaging materials, vendor audit is performed by representative
of Packaging Engineer and Procurement .
5.5.4 Samples of printed packaging materials if necessary shall be submitted to Packaging
engineer.
5.5.5 Purchase department after studying the comments of Packaging engineer shall inform the
supplier for the supply of the material.
5.5.6 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 Approved vendor’s list.

5.6 Procedure for Exclusion of Vendor from Approved Vendor List

The vendor shall be disqualified and removed from the approved vendor’s list for the following
reasons :
a) If a lot does not comply to the specification with respect to critical tests then the vendor shall
be disqualified. The vendor shall be qualified again on further evaluation and investigation.
b) If a lot does not comply to 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 fail to comply the specification in a specified period under review.
d) The delivery schedule is not met for 40% supplies.
e) The rates mentioned in Purchase Order, differs than the rates mentioned in delivery challan
and invoice.
5.6.1 The aspects like the capability of supplier to provide regulatory support, meet the official
requirement shall be evaluated during supplier audit.
5.6.2 The commitment to notify changes to company prior to implementation e.g change in mfg
site, change in process shall be taken.
5.6.3 The commitment to investigate failure promptly in case of any failure reported shall be
assured by the supplier and the capability of supplier shall be evaluated on this front.

5.7 Corrective and Preventive Action

5.7.1 The vendor, who has been excluded from the approved vendor’s list as well as those which
are disqualified and seek inclusion, may be included by only after CAPA verification of previous
items on their satisfactory closure and effective implementation of CAPA.
5.7.2 The vendor shall be made aware of the reasons for his exclusion and shall be asked for
explanation.
5.7.3 Head Purchase, Head QA&QC and GMP Cell shall conduct facility audit of the vendor in
order to ensure that quality system exists in the organization.
5.7.4 Carry out the discussion on other non-quality issues like delivery schedule and rate, etc.
5.7.5 After satisfactory compliance of all above points and ensuring the completion of CAPA
plan, the vendor shall be considered as approved vendor.
5.7.6 The CAPA compliance of previous audit shall be verified in the subsequent audit.
5.7.7 The CAPA verification documents, if any shall be kept along with the audit and
compliance report.

5.8 FREQUENCY

List of approved vendors to be prepared once in a two years or as & when required.

6.0 ABBREVIATIONS:
6.1 SOP: Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 RM: Raw Material
6.5 R&D: Research and Development
6.6 CAPA: Corrective Action and Preventive Action
6.7 GMP: Good Manufacturing Practice
6.8 Mfg: Manufacturing