Vendor Quali ication and Evaluation in Pharmaceutical Industry

To deliver a high quality and safe medicines, it is a must to certify the vendor according to the GMP requirement. This quali ication is done to prevent the adverse events, prevent the recalls or serious illness or death due to the low standard quality of manufactured medicines. Vendor quali ication is the process by which a vendor is assessed to determine, if it can provide the required goods or services to the standards that the purchasing company requires. This article explains about the detailed procedure for qualifying rawmaterial vendors, packaging vendors and service providers. This also explains the vendor assessment and the reassessment. Vendor re-assessment must be carried out at least once a year for each packaging material and the raw material. The manufactured part number is used for tracking. Supply Chain Management team (SCM) should request the QA department to generate Manufacturing Part Number. Explained about the vendor rating. The vendormust be disquali ied if the batch will not adhere to speci ication of critical tests. For further evaluation and investigation, vendor must be once again quali ied. Vendor must be informed regarding the removal and the reasons must be explained clearly. Vendor Relationship Management (SRM), is systematic planning and managing of all interactions with suppliers to maximize its value.

vendor quali ication, manufacturing part number, vendor audit ABSTRACT To deliver a high quality and safe medicines, it is a must to certify the vendor according to the GMP requirement. This quali ication is done to prevent the adverse events, prevent the recalls or serious illness or death due to the low standard quality of manufactured medicines. Vendor quali ication is the process by which a vendor is assessed to determine, if it can provide the required goods or services to the standards that the purchasing company requires. This article explains about the detailed procedure for qualifying raw material vendors, packaging vendors and service providers. This also explains the vendor assessment and the reassessment. Vendor re-assessment must be carried out at least once a year for each packaging material and the raw material. The manufactured part number is used for tracking. Supply Chain Management team (SCM) should request the QA department to generate Manufacturing Part Number. Explained about the vendor rating. The vendor must be disquali ied if the batch will not adhere to speci ication of critical tests. For further evaluation and investigation, vendor must be once again quali ied. Vendor must be informed regarding the removal and the reasons must be explained clearly. Vendor Relationship Management (SRM), is systematic planning and managing of all interactions with suppliers to maximize its value. Chotai (2010) The quali ication process is de ined by the American Society for Quality Control (ASQC) as "the process of demonstrating whether an organization is capable of ful illing the speci ied requirement." Vendor quali ication is the process by which a vendor is assessed to determine if it can provide the required goods or services to the standards that the purchasing company requires. Swathi and Nambiar (2015) A drug product consists of an API, starting materials, excipients and materials used for packaging. These play a major role in assuring the ef icacy and quality of the product. Every vendor must be assessed and must be certiied from the product development stage, until the batch is inished (Chotai, 2010).

Selection of vendors
1. Ensure whether the manufacturer is new to the company or not.
2. Decide whether the API is new or second source.
3. Vendor's reputation assessment should be done.
(a) Check the FDA inspection pro iles (b) Find out the relationships with other companies.
(c) Past history of failure or recall.
4. Check their quali ication of manufacturing process reports 5. Capacity of vendors: This can be checked by specifying them the required quantity and required time to supply the product and one must supply within that time.
6. The location of the vendor is also essential.
7. API selling price should be known, for the sake of pro it evaluation.
8. Technical evaluation must be done.
9. Production samples which are received must be checked for its quality.
10. The quali ication data of inished batch must be checked and reviewed before decision making.
11. Final report is made using the following data, 12. If any change in the management is done, then vendor must be requali ied.

General low chart for vendor quali ication
Vendor quali ication process includes 3 steps, 2. The speci ications for the raw materials and packaging materials will be sent to the vendors.
3. To know about the process, VAQ (Vendor Assessment Questionnaire) will be sent to the vendors by SCM team.
4. Those illed questionnaires from vendors will be received by SCM team.
5. They will send it to QA for review.
6. All the documents sent by vendor shall be reviewed.
7. Vendor must provide the samples and those samples will be tested for its quality.
8. If vendors cannot supply the required number of samples in speci ied time, then they are rejected.
9. The samples provided will be analysed by QC and reported to QA.
10. If the results comply with standards, then QA will plan for a vendor audit.
11. Vendor audit will be planned and scheduled and then conduct an audit.
12. If the results are in compliance, then approval will be given.
13. For qualifying a vendor, mandatory requirement is Vendor Questionnaire, assessment sample analysis and physical audit.
14. For inal approval MPN must be generated (a) In case of raw materials, irst batch which is manufactured will be monitored.
(b) In case of primary packaging material, evaluation like extractability, stability required and leachability studies must be required.
Vendor approval procedure for secondary packaging materials 1. (Pathway, 2017), Supplier chain management department should start the selection of vendor for the supply of the secondary packaging materials.
2. The speci ications for the secondary packaging materials will be sent to the vendors.
3. To know about the process, VAQ (Vendor Assessment Questionnaire) will be sent to the vendors by SCM team.
4. Those illed questionnaires from vendors will be received by SCM team.
5. They will send it to QA for review.
6. All the documents sent by vendor shall be reviewed. Vendor must provide the samples and those samples will be tested for its quality.
8. If vendors cannot supply the required number of samples in speci ied time, then they get rejected.
9. The samples provided will be analysed by QC and reported to QA.
10. If the results comply with standards, then QA will plan for a vendor audit.
11. Vendor audit will be planned and scheduled and then conduct an audit.
12. If the results are in compliance, then approval will be given.
13. For qualifying a vendor, mandatory requirement is vendor questionnaire, assessment sample analysis and physical audit.
14. If in case, any secondary packaging material is obtained from approved vendor, then, that must be approved for new materials based on sample analysis and machine trials.

Manufacturer Part Number (MPN) PartNumber System
Manufacturing Part Number is used within the company as a procedure/system for the departments and the individuals to track and ind out the parts. Categorize the parts in standardized way and create ef iciency in most of the manufacturing processes (Part Number System, 2019).

Factors in luenced while selecting a part number system
1. The plant must use and manage the part numbers while choosing the part number system.
2. It is very dif icult to switch from one-part number to another; if team is well known with the previous part number, the new part number must have improved the ef iciency.
3. If you are starting the number system, then you have to consider the following, 5. You must get feedback from the team members on how to structure a system.
6. Is the part number given to the vendors/ suppliers?
7. You must know which part number to be used.
8. You have to manage the part numbers. Vendor quali ication for service providers:
2. Explain the quality agreements which distribute the regulatory responsibilities 3. Qualify the product attributes which are manufactured, by inspection and independent veri ication.

Practically visiting every vendor is not possible.
Before planning an audit, 5. A thorough review of the irm's regulatory history, followed by a desk-based audit of process documents for cGMP compliance, may yield vital information about the overall quality of manufacturing operations.
6. Identi ication and mitigation of risk factors is essential in deciding what level of scrutiny to apply to a irm. 3. When three continuous batches are observed, and those batches are not adhering to the speciications of minor test, then vendor must be disquali ied.

Procedure for removal of vendor from the approved list
4. When reviewed, if 3 batches among 10 batches fail to meet out the speci ications, then, the vendor must disqualify.
5. For 40% of the supplies, if the delivery schedule is not followed, vendor is disquali ied.
6. If vendors are disquali ied, then, there is difference in prices among the purchase order and the invoice.

Corrective Action and Preventive Action
If vendor is removed from the approved list, then inclusion of vendor can be done by following CAPA, 1. Vendor must be informed regarding the removal and the reasons must be explained clearly.
2. To ensure the existence of quality system in the organization, facility audit must be conducted by head of purchase department, quality assurance head and quality control department.
3. Low quality issues such as the schedule of delivery and speed of delivery must be disquali ied.

4.
After adequate adherence to all the points above, vendor inclusion can be done in the vendor list which is temporary.

Vendor Audit
(Vendor Audit, 2019), To audit a vendor following must be considered,

Use of records in an informal manner
In the case of vendor assessment, the information may be collected from different sources like diaries, log books, inancial records or journals. Information may also be collected from the past history. This information may allow the evaluation of an event in a better way and can help making wiser decisions.

After the fact evaluation
After completion of an event, by answering the questions asked by the auditor, helps in collecting data for future plans and decisions.

Before designing the fact
In this case, the auditors gather the data regarding the history of the project.
There are many tools and tips through which the industries successively rate their vendor's and suppliers, track performance and continuously increase overall productivity of the industry.

Establish performance indicators
At the beginning, the managers have to think and determine, all the characteristics that a vendor should have, to create speci ic performance criteria for assessing and tracking the vendors and suppliers regularly on quarterly, monthly or annual basis.
The things which are to be assessed are the size of the company, QMS number of certi ications, complaint history etc.

Classify Multiple Vendors and Suppliers
If the company has a large number of vendor's, suppliers and managers, they will design a survey to assess them. It will be different to apply a survey to each and every vendor. Hence, vendor should be assessed by classifying them into different levels based on the effect they have on your product or service.

Plan an evaluation method
common methods used to evaluate a vendor or supplier are survey evaluation forms software application and system metrics.
They have to conduct audits regularly

Vendor quality evaluation
The quality of the vendors can be evaluated by considering the following points,

CONCLUSIONS
The process of vendor quali ication essentially deals with the selection of vendors, which is a technique for evaluating the suitable vendors for the industries. It helps in selecting a limited number of vendors by conducting detailed analysis. After analysing the vendors by using suitable procedures, the best vendor is selected among them. If there is any change in the management, then requali ication is done.