Title: Vendor Evaluation and Approval
- Objective:
To define procedure for Evaluation, Approval, Re-evaluation and Disqualification of Vendor/Supplier of Raw Materials, Primary and Printed Packaging Materials.
- Scope:
This procedure is applicable to Vendors/Suppliers of all Raw Materials, Primary and Printed Packaging Materials.
- Responsibility:
| HOD (Planning & Purchase) | : | Sourcing the New Vendors and communication with vendors.
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| HOD
(Production.) |
: | Evaluating production related details and recommending suitable vendors. |
| Manager (Logistics) | : | Evaluating delivery performance and communicating to HOD (QA).
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| HOD (QA)
|
: | Evaluating the quality related details and vendor audit approval / re-approval of suitable vendors. |
- Accountability:
Head QA Department
- Procedure:
5.1 Definitions:
Approved Vendors: A supplier or manufacturer or the combination of both which has been assessed and approved for a specific materials and included in approved vendor list.
5.2 Procedure :
| 5.2.1 | The following inputs are required for vendor qualification:
—Vendors are identified through personal references catalogues, trade journals, exhibitions, business directories and internet. — Particulars required for manufacturer / supplier capability evaluation (data received through audit or self assessment questionnaire and communication with the suppliers). — Sample inspection and test data. — Development batch production data. — Data of supplies. — Supplier audit data. — Supplier certificate of Analysis (COA). |
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| 5.2.2. | Raw Materials (Excipients) | |
| 5.2.2.1 | Information about vendor background and capability shall be collected upon identification of a prospective source. | |
| 5.2.2.2 | Specifications and vendor assessment form (questionnaire) shall be sent to supplier to evaluate the Quality Management System / GMP system implemented in the supplier premises. | |
| 5.2.2.3 | If the vendor is only a dealer or supplier of manufacturer then it shall be ensured that the dealer or supplier is one of the authorized suppliers of the manufacturer. Authorization letter from the manufacturer shall be sought in this regard. | |
| 5.2.2.4 | It shall be ensured that the supplier provides the COA, filled assessment questionnaire and technical information about the required product/material along with the sample of 3 consecutive batches for QC evaluation purpose. Without COA and filled assessment form (questionnaire), samples shall not be accepted. | |
| 5.2.2.5 | It shall be ensured that COA of given product/material meets the relevant Pharmacopoeia/IH specification. | |
| 5.2.2.6 | Criticality of the parameters mentioned in the supplier COA which could impact the quality of the product manufactured, shall be analysed jointly. | |
| 5.2.2.7 | Received filled assessment form (Questionnaire) shall be reviewed for compliance and the comments shall be recorded. | |
| 5.2.2.8 | Approval / rejection of the vendor shall be done on the basis of compliance of the raw material analysis on 100% sampling basis for the first 10 supplies or until the successful audit /assessment by manufacturer. | |
| 5.2.2.9 | The supplier shall be ordered for supply of materials as per SOP. | |
| 5.2.2.10 | Approved vendor list mentioning material code, material description, monograph / pharmacopoeial grade, material grade, manufactured for, manufacturer name with complete address, contact person, contact details and supplier name with complete address, contact person, contact details is prepared, updated, maintained and approved as specified in Annexure
Copies of such approved vendor lists shall be made available to the warehouse and quality control department. |
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| 5.2.2.11 | Continuous vendor evaluation shall be done on the basis of performance, quality, delivery etc. and shall be recorded. | |
| 5.2.2.12 | If any non conformance observed in the materials or services, a letter shall be sent for review and tracking of corrective action to be taken by the supplier. | |
| 5.2.2.13 | Validity period for all approved vendor/supplier shall be assigned as three years the date of inclusion in approved vendor/supplier list. | |
| 5.2.3 | Raw Materials (API) | |
| 5.2.3.1 | In addition to above procedures following additional steps shall be followed for approval of API vendor/supplier:
— The vendor shall be audited by QA personnel or any other competent authorized person prior to purchase of material for on spot assessment of particulars provided by them in vendor assessment form (questionnaire). — The manufacturer/supplier that has a valid GMP certificate, shall be selected, evaluated and approved. |
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| 5.2.4 | Packing Materials | |
| 5.2.4.1 | The primary and printed packing material (primary printed label, cartons and leaflets) vendor shall be approved on the basis of vendor assessment form (questionnaire) filled by vendors and on site audit (wherever possible). | |
| 5.2.4.2 | The vendor/supplier shall be ordered to supply first ten supplies of the primary and printed packaging materials with COA and shall be completely tested to justify approval. | |
| 5.2.4.3 | The supplies from approved vendors should be accompanied with a QC sample on the basis of decided criteria. | |
| 5.2.4.4 | For secondary packing material supplier shall be asked for providing sample of materials and Assessment Questionnaire. | |
| 5.2.4.5 | On the basis of quality of the sample and evaluation of assessment questionnaire, the vendor and supplies shall be approved. | |
| 5.2.5 | Re-evaluation of vendor/suppliers | |
| 5.2.5.1 | Monitor the performance rating half yearly to check the effectiveness of the vendor with quality and price for the supplied material as per criteria. | |
| 5.2.5.2 | A vendor evaluation register (Quality performance rating record) shall be prepared from data collected of the respective vendors/supplier. | |
| 5.2.5.3 | Re-evaluation of all vendors is done once in three years by QA Department on the basis of consistency in the quality of the supplied material and takes decision either to extend or stop the validity period of the supplier. | |
| 5.2.5.4 | Where it is possible to take corrective action, it shall be communicated the same to the vendors otherwise be removed the vendor name from the approved list. | |
| 5.2.5.5 | Manufacturer / suppliers for API shall be site audited once in three years for their continuing QMS. Assessment form questionnaire for suppliers are sent once in two year to evaluate the up gradation of their facility / system if any. | |
| 5.2.5.6 | The supplier who was not issued purchase orders for a period of three years will get automatically removed from the approved vendor list. | |
| 5.2.5.7 | In case if deleted suppliers are required to be enrolled once again for future supplies, they shall be undergone the specified evaluation and selection procedure. | |
| 5.2.5.8 | The final recommendations shall be made which shall include following:
—Re-approval based on re-evaluation particulars. —Inclusion of new supplier and the products approved for supply. —Needs of corrective action by the supplier. —Deletion of a supplier from approved list. |
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| 5.2.5.9 | On the basis of above, the approved vendor list shall be updated as well as decisions communicated to the vendors. | |
| 5.2.6 | Disqualification of suppliers | |
| 5.2.6.1 | The vendors are disqualified on the basis of critical, major and minor categories:
Critical: Any supply of the material rejected on quality grounds is termed as critical and vendor is disqualified and all purchases are suspended with immediate effect. Major: If the corrective action taken by the manufacturer is not satisfactory, then the vendor shall be disqualified. If the vendor does not meet the delivery date and delay is over 15 days or five consecutive supplies are delayed, the vendor shall be disqualified. Minor: If the corrective action is satisfactory, further procurement shall be carried out after onsite verification. If the supplies do not comply with one or two in-house physical parameters, then the vendor shall be disqualified. |
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| 5.2.6.2 | The basis of vendor’s performance rating shall be as follows:
PERFORMANCE: Performance evaluation shall be done on 0 to 2 scale and is based on his overall perception, which includes parameters like responsiveness, flexibility, cooperation, price, production/ supply capacity, etc. This evaluation is done by head Planning & Purchase department. QUALITY: Done on 0 to 10 scale based on the quality of supplies. Each consignment shall be given appropriate rating after inspection. Rating of 10 shall be given in case if no shortcoming from QC. In case of lot rejection, a rating of 0 shall be awarded. In between cases, including acceptance under concession, head QA shall provide approvals rating of 1 to 9. DELIVERY: Manager (Logistics) shall provide the date of delivery based on which information the Head QA shall rate the supplies on 0 to 3 scales. If the supplies are within time, a rating of 3 shall be awarded; delay of upto 20 days attracts a rating of 2; 21-30 days – 1; over 1 month – 0. CALCULATION: Total rating of ‘Performance’, ‘Quality’ and ‘Delivery’ is obtained by adding the three. For quarterly average, sum of total ratings for supplies in a quarter is obtained and divided by the number of supplies received. |
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| 5.2.6.3 | In case the quarterly average is below 6, a warning letter is sent to the vendor. The party shall be continuously monitored for performance improvement. | |
| 5.2.6.4 | In case the overall rating falls below 6, the party shall be blacklisted and all purchases from it shall be suspended. In case of proprietary product / single source, the purchases may be continued with approval from the QA. | |
| 5.2.6.5 | In case of disqualification, the vendor shall be informed the basis on which the disqualification was done. | |
| 5.2.6.6 | The record of vendor qualification/disqualification shall be is maintained by QA Department |
- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| GMP | Good Manufacturing Practices |
| HOD | Head of Department |
| COA | Certificate of Analysis |
| API | Active Pharmaceuticals Ingredients. |
| QMS | Quality Management System |
*Note – Ready to use SOP available in “DOWNLOAD” Section.