sop for evaluation and qualification of vendor who supply packing material

OBJECTIVE
1.1 To describe a procedure for evaluation and qualification of vendor who supply packing material.
SCOPE
2.1 This procedure is applicable to all vendor, who are supplying packing materials at
RESPONSIBILITY
3.1 Purchase Department shall search the suitable vendor for requirements of products.
3.2 QC Department shall responsible for analysis of vendor sample.
3.3 QA Department shall responsible for new vendor development, coordinating with vendors for

questionnaires, pre-shipment samples and vendor audits.
ACCOUNTABILITY
4.1 Department Head
4.2 Head QA
PROCEDURE
5.1 Vendor Identification:
5.1.1 A need for new vendor identification may arise due to:
5.1.1.1 A new product launch.
5.1.1.2 An alternate vendor identified by Purchase Department.
5.1.1.3 Existing vendor with an additional item.
5.1.1.4 Present supply is not satisfactory (Logistic or quality) or any other reason.
5.1.2 In case of new product launch, vendors shall be approved before commencing of plant validation batches.
5.1.3 As per requirements, Purchase Department shall identify vendors based on:
5.1.3.1 Quality management system and regulatory status of the firm.
5.1.3.2 Technical capabilities of the firm.
5.1.3.3 Financial soundness and performance of the company.
5.1.4 Materials shall be preferably procured by direct manufacturer, in case if materials are to

be procured from the trader or supplier, familiarity of trader to the pharmaceutical supply shall be considered.

5.2 Vendor Approval:

5.2.1 Vendor shall be approved based on following criteria:
5..2.1.1 Criticality of material.
5..2.1.2 Regulatory approval status of the firm.
5..2.1.3 Quality management system and technical capabilities of the firm.
5.2.1 Supply of other materials from same vendor.
5.2.3 Based on the above parameters, vendors shall be approved through following methods:
5.2.3.1 Questionnaire
5.2.3.2 Sample Analysis
5.2.3.3 Use Test
5.2.3.4 Site Audit
5.2.4 Purchase Department shall forward the vendor questionnaire to identified vendors.
5.2.5 Specimen of raw material vendor questionnaire is as in Format No.: “Packing Material Vendor Questionnaire”.
5.2.6 After receipt of the filled questionnaire from vendor, Purchase Department shall send the questionnaire

along with the documents received to Head QA.
5.2.7 Head QA shall scrutinize the questionnaire and document received, if required QA shall request

for vendor samples to Purchase Department.
5.2.8 Purchase Department shall procure samples along with vendor specification, testing procedures,

COAs, standards and any other enclosure required.
5.2.9 QA shall review the materials specifications as per requirements and shall forward the samples to QC for analysis
5.2.10 After QC analysis reports Head QA shall do the analytical evaluation. If required QA shall decide

for process trails with the procured sample.
5.2.11 After process trail, QA shall scrutinize the process use test reports.
5.2.12 If required, Head QA shall decide for vendor site audit and shall inform accordingly to Purchase Department.
5.2.13 Purchase Department shall coordinate the vendor audit arrangements.
5.2.14 Vendor audit team shall consist of representatives from concern department like Purchase, Production, QC and QA.
5.2.15 Audit team shall review the vendor for quality, manufacturing process capabilities, delivery and

commitment to prevent quality problems.
5.2.16 Vendor audit checklist shall be used, as an indicative and inspection shall not be limited

or exhaustive to the checklist.

5.2.17 Audit team shall submit the audit report with recommendation for approval or disapproval of the vendor to Head QA.
5.2.18 Head QA shall review the vendor audit report and shall decide approval or disapproval of the vendor.
0 After approval of the vendor, QA personnel shall give intimation of new vendor as per SOP No.: “Information of New Vendor”.
5.2.20 The specimen format of approved vendor list is as in Format No.: “Approved Vendor List (PM)”.
5.2.21 QA personnel shall updated and distribute the approved vendor list to QC and Store Department.
5.2.22 Based on approved vendor list QA shall enter the vendor details in MARG software.
5.2.23 In case of qualification of new vendor and disqualification of existing vendor, QA shall intimate to all

concerned department. QA shall enter the new vendor details/delete vendor name (as applicable).

QA shall revise ‘Approved Vendor List’ every after 6 months and issue copy of the same to QC and Store Department.
5.2.24 The performance of the key packing material vendors shall be evaluated by trending analysis result and rejection details.
5.2.25 Vendors shall be re qualified after five years, however requalification shall be done in case if vendor

has made any major changes in facility, process or there is consistence quality problems in the supplied

materials or quality problems in the process related to the supplied materials.
Vendor Requalification:
5.3.1 Requalification of the vendors shall be done based on historic evaluation of supply, however requalification

shall be done through sample analysis or use test or vendor audit in case if vendor has made any major

changes in facility, process or there is consistence quality problems in the supplied material or quality

problems in the process related to the supplied materials.
Vendor Disqualification:
5.4.1 In case of out of specification in any approved material founds vendor shall be informed with appropriate action plan.
5.4.2 Vendors shall be disqualified from approved vendor list, if the material found in out of specification

results three times by same manufacturer.
5.4.3 Depending on nature of complaint received with respect to quality of material supplied by vendor,

QA Head can black list the respective vendor and the same shall intimate to all concern

(Purchase, Store and Quality Control Department) as per SOP NO.: format ‘Information of Black Listed Vendor’,

Format No.: and the approved vendor list shall update accordingly.

6.0 TRAINING
6.1 Trainer – Head-QA
6.2 Trainee – All Concern Person.
6.3 Period – One hour or as per required.
7.0 DISTRIBUION
7.1 One set of master copy & controlled copy submitted the quality assurance department.
8.0 ENCLOSURE
8.1 REFERENCES
8.1.1 Schedule M :
8.1.2 WHO GMP:
8.2 : Packing Material Vendor Questionnaire
8.3 : Approved Vendor List (PM)
9.0 ABBREVIATIONS
9.1 SOP : Standard Operating Procedure
9.2 QA : Quality Assurance
9.3 GMP : Good Manufacturing Practice
9.4 WHO : World health organization
9.5 QC : Quality Control
9.6 No. : Number