.0 OBJECTIVE:
To lay down the procedure for the qualification of vendors for the Raw materials and Packaging
materials.
2.0 SCOPE:
This SOP shall be applicable for all the incoming Raw materials and Packaging materials used
for Own & Contract manufacturing sites.
3.0 RESPONSIBILITY:
QA Officer / QA Executive
4.0 ACCOUNTABILITY:
Head- QA & QC
5.0 PROCEDURE:
5.1 Procedure for inclusion of vendor in approved vendor list (Raw materials)
5.1.1 New vendors shall be qualified and approved by QA department before regular supply of
raw materials.
5.1.2 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 vendor.
5.1.3 In case of RM source, after the initial assessment, Purchase department shall arrange to get
the Supplier Questionnaire filled by the supplier.
5.1.4 If the Questionnaire evaluation is found suitable, Purchase department after discussion with
R&D and QA shall ask for 3 batches of samples along with certificate of analysis of in-house &
Public Testing Laboratory for quality evaluation and subsequent stability studies.
5.1.5 Purchase department shall arrange to send 3 batches of samples along with New Source
Request form to R&D for quality evaluation and stability testing.
5.1.6 R&D shall send the samples along with New Source Request Form to QA Head for
evaluation
5.2 New Source Request Form
There are three types of new sources.



New material from a new source.
Existing material from a new source
New material from an existing approved source.
5.3 Evaluation of a New Source
5.3.1 QC shall analyse the samples sent by R&D as per approved specifications and testing
procedures.
5.3.2 If the samples are found to be in compliance with the specifications, QA shall send the
analytical report to R&D along with the New Source Request Form.
5.3.3 R&D, in consultation with QA shall decide the criticality and necessity of carrying out
usage test and stability studies. The necessity of carrying out machine trials shall also be
evaluated by R&D, in consultation with QA / Production.
5.3.4 R&D, shall carry out the usage test and machine trials, if required. R&D, will also
recommend the need to do stability studies, if required, and communicate the same with other
recommendations to Head QA.
5.3.5 Following the evaluation carried out depending on the criticality of the material, the Head
QA shall recommend an audit of the Supplier’s premises.
5.4 Approval of New Source
5.4.1 The facilities and operations of the supplier’s manufacturing site must be subjected to a
quality audit before the materials are used. Audit shall be conducted by the respective Quality
function.
5.4.2 In case when the new material is from an already approved source, the approval may be
recommended based on the pre-approval Questionnaire evaluation after completing New Source
Request form.
5.4.3 If the supplier’s facilities and operations meet requirements as documented in the audit
report then the respective Head QA shall approve the supplier.
5.4.4 The auditor must arrange to send the signed copy of audit report to the audited supplier.
5.4.5 After approval, Head QA, where the material is used, shall give clearance for Procurement
of procuring a limited quantity of material for use in 3 production batches and evaluate these
three batches critically for quality.
5.4.6 Purchase department shall carefully study the quality aspect and also the quantity and
financial aspects of the vendor, they are as follows:
a) Capability of the vendor to supply the required material within the period.
b) Delivery schedule in order not to affect the production cycle.
5.4.7 Purchase department shall find out the rates quoted by the vendor whether they are
competitive with respect to other vendors without compromising the quality aspects.
5.4.8 On ensuring compliance with specifications the vendor shall be included in approved
vendor’s list.
5.4.9 All the suppliers of RM evaluated by R&D dept. On the basis of process / product
development parameters shall be considered as temporary vendors and based on the commercial
production supply, they shall be transferred to approve vendor list and shall be considered as
approved vendors.
5.4.10 After vendor audit, a vendor audit report classifying the observations as critical, major and
minor with recommended corrective and preventive actions (CAPA) shall be issued to the
vendor within 20 days for audit.
5.4.11 The Vendor shall reply to the audit report with the action plan on CAPA along with the
expected date of completion of CAPA items.
5.4.12 The quality function shall follow up for with the supplier on the implementation and
compliance of the CAPA items suggested in the CAPA plan.
5.5 Procedure for Inclusion of Vendor in Approved Vendor List (Packaging
Materials)
5.5.1 New vendors must be qualified and approved by QA department 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 QA department and GMP Cell.
5.5.4 Samples of printed packaging materials if necessary shall be submitted to QA department.
5.5.5 Purchase department after studying the comments of QA department 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