SOP FOR VENDOR QUALIFICATION | STANDARD OPERATING PROCEDURE FOR VENDOR QUALIFICATION

1.0 OBJECTIVE

1.1 To lay down the procedure for identification, selection, evaluation, and qualification of Vendors.

2.0 SCOPE

2.1 This procedure is applicable to qualify the vendors of all the Raw and Packaging materials procured for Pharmaceutical Manufacturing Facilities of ……………………

3.0 RESPONSIBILITY

3.1 Head – Purchase or designee for identification and selection of a vendor.

3.2 Quality Assurance in-charge or designee for the evaluation and qualification of the vendor.

3.3 Head – Production or designee for performing the trial batch study of the sample supplied by the vendor.

3.4 QC for the analysis of the samples.

3.5 Head-Quality Assurance for implementation/compliance of this procedure.

4.0 ACCOUNTABILITY

4.1 Head-Quality Assurance/his designee

5.0 PROCEDURE

5.1 Identification of the Vendor:

5.1.1 The following options qualify for vendor approval:

5.1.1.1 New material from a new vendor

5.1.1.2 New material from an existing vendor

5.1.1.3 Existing material from a new vendor

5.2 Production shall raise the purchase requisition to Purchase Department for the procurement of material along with tentative specifications and the quantity required.

5.3 Based on the information from Production for new materials and Purchase on its own for the alternate vendor, shall initiate queries with the prospective vendors for their capability, supply history, future supplies, and specific cGMP requirement for the supply of material.

5.4 Purchase representative shall coordinate with vendors in matters concerning identification and selection of vendors, signing of the confidentiality agreement, and another commercial issue.

5.5 Vendor development for Active Pharmaceutical Ingredients (API)

5.5.1 API sourcing team (comprising the members from Purchase, Production QC, and QA) shall collect the information as detailed in the Initial Assessment checklist (Annexure 1) from different vendors.

5.5.2 API sourcing team shall review the details provided in the Initial Assessment checklist and identify the prospective vendor.

5.5.3 Based on the initial assessment and acceptability, Purchase Department shall send the tentative specification to the vendor and arrange the sample(s) for technical evaluation along with the certificates of analysis, standards for actives, impurities, stability data, and price for commercial evaluation.

5.5.4 Production, QC shall review the COA.

5.5.5 Sample(s) received from the vendor shall be tested for compliance as per the approved specification and test methods.

5.5.6 If the sample(s) are acceptable, Production shall advise the Purchase Department for the procurement of raw material for a trial batch. Where necessary, production, QC may ask for any additional/specific requirement.

5.5.7 On receipt of the material, Production shall initiate for the user trial as necessary.

5.5.8 Based on the user trials, the API sourcing team shall finalize the vendor who shall be subsequently evaluated and qualified for commercial supplies.

5.5.9 The vendor shall be evaluated based on the following qualification criteria.

5.5.10 Three separate lots from the vendor satisfactorily tested and approved as per specifications.

5.5.11 Certification of the vendor based on any of the following

5.5.12 Satisfactory on-site inspection

Note: Vendor Audit Questionnaire shall be considered as a checklist for Onsite Inspection as detailed in Annexure 2. However, the auditing need not be limited to the checklist. A summary report shall be prepared as detailed in annexure 6.

5.5.13 Certification by the officially accredited body (like ISO, TGA, MHRA,

MCC, ANVISA, USFDA)

5.5.14 Self-assessment by the vendor using Vendor Audit Questionnaire as detailed in Annexure2.QA shall evaluate the questionnaire supplied by the vendor.

5.5.15 The necessary documentation with respect to GMP certification, TSE/BSE free certificate, gluten-free certificate, and impurity data shall be obtained.

5.5.16 After the review and evaluation, Head QA shall approve the vendor, and the name of the vendor shall be incorporated in the Approved Vendor List.

Note: With one lot testing, vendors of raw materials may be 'provisionally qualified' for use in exhibit/submission batches.

5.6 Vendor development for Raw Materials other than API

5.6.1 Purchase Department shall send the material specification to the prospective

vendors and arrange the sample(s) for technical evaluation along with the certificates of analysis.

5.6.2 Production/ QC shall review the sample and COA, where necessary.

5.6.3 Sample(s) received from the vendors shall be tested for compliance as per the approved specification and test methods by QC.

5.6.4 If the sample(s) are acceptable, Production shall advise the Purchase Department for the procurement of raw material. Where necessary, PD/QC may ask for any additional/specific requirements.

5.6.5 The vendor shall be evaluated based on the following qualification criteria.

5.6.6 Three separate lots from the vendor satisfactorily tested and approved as per specifications.

5.6.7 Certification of the vendor based on any of the following

5.6.8 Satisfactory on-site inspection

Note: Vendor Audit Questionnaire shall be considered as a checklist for Onsite Inspection as detailed in Annexure 2. However, the auditing need not be limited to the checklist. A summary report shall be prepared as detailed in annexure 6.

5.6.9 Certification by the officially accredited body (like ISO, TGA, MHRA, MCC, ANVISA, USFDA)

5.6.10 Self-assessment by the vendor using Vendor Audit Questionnaire as detailed in Annexure 2.QA shall evaluate the questionnaire supplied by the vendor.

5.6.11 The necessary documentation with respect to GMP certification, TSE/BSE free certificate, Gluten-free certificate, and impurity data shall be obtained.

5.6.12 After the review and evaluation, Head QA shall approve the vendor, and the name of the vendor shall be incorporated in the Approved Vendor List.

Note: With one lot testing, vendors of raw materials may be 'provisionally qualified' for use in exhibit/submission batches.

5.7 Vendor development for Primary/Printed Packaging Materials

5.7.1 Purchase Department shall send the material specification to the prospective vendors and arrange the sample(s) for technical evaluation.

5.7.2 PD/ QC shall review the sample and COA, where necessary.

5.7.3 Sample(s) received from the vendors shall be tested for compliance as per the approved specification and test methods by QC/Packaging Department.

5.7.4 If the sample(s) are acceptable, Production shall advise the Purchase Department for the procurement of Packaging material. Where necessary, a trial batch may be taken for evaluation of machine suitability.

5.7.5 QA shall evaluate the vendor based on the following qualification criteria.

5.7.6 One lot from the vendor satisfactorily tested and approved as per specifications.

5.7.7 Trial batch qualifies the machine suitability test (if applicable)

5.7.8 Certification of the vendor based on any of the following

5.7.9 Satisfactory on-site inspection

Note: Vendor Audit Questionnaire shall be considered as a checklist for Onsite Inspection as detailed in Annexure 3. However, the auditing need not be limited to the checklist.

5.7.10 Certification by an officially accredited body.

5.7.11 Self-assessment by the vendor using Vendor Audit Questionnaire as detailed in Annexure 3.QA shall evaluate the questionnaire supplied by the vendor.

5.7.12 In case there is any change in existing Packaging material or addition of any new material w.r.t printed text/ dimensions only and which does not affect the vendor quality system evaluation, the Approved vendor list shall be updated as follows.

5.7.13 The Packaging Department shall evaluate the effect of such changes.

5.7.14 QA shall review the evaluation made by the Packaging department and based on the evaluation approved vendor list shall be updated.

5.8 Approved Vendor List

5.8.1 Approved Vendor List/Provisional Vendor List shall be prepared by QA as per the format as detailed in Annexure 4 and 7.

5.8.2 In case of any change of vendor status (addition/deletion/change of status from provisional to an approved vendor), the approved vendor list shall be revised once in 6 months and the revision number and effective date shall be updated.

5.8.3 Revised copies shall be forwarded to all the user departments.

5.9 Re-qualification of a Vendor

5.9.1 The approved vendor(s) continues to remain approved on the basis of their past performance unless the need arises for their appraisal.

5.9.2 All the vendors mentioned in the approved vendor list shall be re-qualified periodically either through an on-site inspection (audit), recent quality systems certification by an officially accredited body, or a self-assessment by the vendor.

5.9.3 The frequency of Re-qualification is as follows

5.9.4 Active Pharmaceutical Ingredient (API): Once in two years

5.9.5 Raw materials other than API: Once in four years

5.9.6 Packaging material: Once in four years

5.9.7 If the existing approved vendor is offering any additional item manufactured in the same facility then the vendor shall be qualified based on the supply of three separate lots.

5.10 Disqualification of a Vendor

5.10.1 The following conditions shall apply for disqualification of a vendor

5.10.2 The Material supplied does not meet the agreed specifications (last three consignments)

5.10.3 Contaminated material is delivered which would adversely affect the product quality

5.10.4 Inability of a vendor to comply with the gaps identified during an audit, which have an impact on the product quality.

5.10.5 The information regarding disqualification shall be communicated to all concerned

and the name shall be deleted from the approved vendor list.

5.11 Re-qualification of disqualified vendor

5.11.1 A disqualified vendor shall be treated as a new vendor for the purposes of re-qualification

5.11.2 The re-qualification process shall be through a change control system

5.11.3 Change control shall be initiated by Purchase Department.

5.11.4 Any change in the Approved vendor already supplying a material shall be carried out as

per SOP on `Change Control Programme` (SOP NO…………..).

Note: Vendor is also considered as an approved vendor if the vendor has been evaluated & approved by other Crescent therapeutics limited, formulation units.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

6.2 No - Number

6.3 QA - Quality Assurance

6.4 QC - Quality Control

6.5 cGMP - Current Good Manufacturing Practices

6.6 API - Active Pharmaceutical Ingredient

7.0 REFERENCES

7.1 SOP NO………….. - Change Control Programme

8.0 ANNEXURES

8.1 Annexure: 1 - Format of Initial Assessment Checklist (for API).

8.2 Annexure: 2 - Format of Vendor Audit Questionnaire (Raw Materials)

8.3 Annexure: 3 - Format of Vendor Audit Questionnaire (Packaging Materials)

8.4 Annexure: 4 - Format of Approved Vendor list.

8.5 Annexure: 5 - Format of Provisional Vendor list.

8.6 Annexure: 6 - Format of Vendor Audit Report

END OF DOCUMENT

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