1) Vendor qualification is the process used by finished dosage form manufacturers to approve vendors for active pharmaceutical ingredients (APIs) that will be used in products. It involves selecting vendors based on criteria like quality, delivery, price, and auditing them. 2) Vendors are categorized as A, B, or C depending on which tests they perform on APIs. Category A vendors perform all tests, B vendors are well-known and certified, and C vendors undergo full testing by the manufacturer. 3) The vendor qualification process determines if a vendor is suitable and can consistently supply quality APIs. It aims to develop long-term supplier relationships and ensure regulatory expectations are met.

1. Vendorqualification
D E E K S H I T H A H S
P H A R M A C E U T I C A L Q U A L I T Y A S S U R A N C E
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2. Introduction
Vendor or Supplier is the seller of the API to manufacturer of finished dosage form or Vendor
means a person who sells & supplies his products
SELECTION OF VENDOR :
It is the process where by the vendor is approved by the finished dosage form manufacturer for
given API that will be used in specific product.
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3. TYPES OF VENDOR
1) Category A vendor
-performs all tests listed in the dosage form manufacturer’s material specification are performed by the
vendor’s laboratory.
2) Category B vendor
• Well known suppliers of standard containers ,closures ,raw materials and excipients .
• Certified to an International Standards Organization (ISO)9000 quality management system.
• Enhanced monitoring is suggested.
Testing will be conducted upon receipt to verify acceptability of materials
3) Category C Vendor
Undergoing qualification process where the manufacturer has to perform all the tests.
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4. Vendor selection criteria:
1. Quality
2. Delivery
3. Performance history
4. Warranties and claim polices
5. Production facilities and capacity
6. Financial position
7. Price
8. Technical capability
9. Procedural compliance
10.Communication system
11.Reputation and position in industry
12.Desire for business
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5. 1) Consider that manufacturer is new to the company or not.
2) Determine that API is new or second source.
3) Evaluate the vendor’s reputation:
Checking the FDA Inspection Profiles or Establishment Inspection Report.
Relationship with other Company
Vendor’s Recall and failure History
4) Define the vendor’s operation, as discussed previously. In order to qualify a
vendor properly, it is imperative to know if the vendor is manufacturer&, in this
proposed program, we must “qualify each manufacturing process.
5) CAPACITY OF VENDOR: Supply the quantity in required amount and in
required time. It is wasteful to qualify a vendor if he is not fulfilling requirement in
given time.
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6. 6)LOCATION OF VENDOR: Providing supply in regular production schedule. In
sudden increase in demand local suppliers easily supply the API. Foreign
manufacturer maintain inventories in local area
7) SELLING PRICE API: Necessary for profit evaluation.
8)TECHNICAL EVALUATION: Three lots from API manufacturer are taken for
testing
9) Request for technical dossier from API manufacturer
validated test methods
impurities data
standards for testing
chromatogram
stability data on marketed container .This data helps in final product specification
10) Test the production samples received in laboratory.
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7. 11) Vendor audit carried out by manufacturer all operation of supplier
12) Produce a qualification lot of finished dosage form product using API
• The resultant data are taken for review and decision making.
• If API is second source it is it is taken for comparison with regular lot.
13) Final Report : It is made on following data
• vendor’s background information
• audit report
• laboratory findings
• regulatory affairs
14)Emphasizing a change control:
• SOPs are prepared for the change in document given by the supplier.
• revalidation
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9. Why to qualify vendors ?
• Used to determine if the vendor is appropriate for the scope of work.
• Critical attributes of a partner relationship are Supplier or customer commitment to a long term
relationship.
• Information sharing.
•Joint agreement on specifications and performance standards.
• Performance measurement and feedback.
• Customer confidence in the supplier’s manufacturing capability, quality, cost, and development.
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10. Q.U.E.S.T. Approach
Q = Question Phase: What a potential vendor needs to supply
U = Understanding Phase: How vendors meet the requirements
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11. E = Evaluation Phase: Identification of the best potential vendor
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12. S = Site Audit Phase: Onsite and offsite verifications
T = Track Phase: Monitor and requalify
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13. VENDOR EVALUATION
One of the most important processes performed in organizations today is the evaluation, selection &
continuous measurement of suppliers
Criteria's are fundamental to choose the best supplier
The evaluation is done especially on two counts, namely quality and delivery
The purpose of vendor evaluation is to ensure a portfolio of best in class suppliers is available for use
Based on the information obtained via the evaluation, a supplier is scored & either approved/unapproved as
one from whom to procure materials or services
Approved supplier list - qualified supplier is then added
Approved vendor- re-evaluated periodically or annually
Suppliers are selected according to their ability to supply quality goods
Audit vendor list - listing of various types of suppliers & providers that a company has agreed meets its
standards in terms of quality and price
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14. VENDORS AUDIT
There are many elements in an audit that is conducted by a dosage form manufacturer or regulatory agency of
the facility that manufactures an API.
The person conducting the audit may want to use a checklist developed for this purpose for two main reasons:
1) The checklist will include all areas of the audit to be covered so that nothing will be forgotten.
2) Boxes on the checklist can be marked, with brief comments that can be added by the auditor, obviating the
need for much time spent writing,& allowing for more time to be spent observing the facility & asking plant
personnel questions in a dialogue box.
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16. Vendorcertification
Vendor certification is a supplier-customer partnership and can only be successful
with the full involvement and agreement of both partners.
OR
It is the combination of activities required to ensure that a vendor will meet the
professional and regulatory expectation of the sponsor.
OR
It is the system that assure that a supplier’s product is produced under controlled
condition, resulting in consistent quality Conformance.
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17. Benefits of the Certification Process :
o Pharma firms will then not have to carry out their own quality audit of the vendor.
o Vendors will be assured that customers of the product will not expect to carry out their own
quality audit of their systems or products.
o Rapid and efficient qualification process prior to sale and delivery/acceptance of a system.
o Reduced cost.
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18. Decertification:
• Any failure by the supplier for matching the customer’s requirement , may lead
to decertification of that supplier for that material.
• Depending on the nature of the problem it may be possible to work with the
supplier to re-establish certification.
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19. CGMP REQUIREMENTS FOR VENDOR
QUALIFICATION:
Divided into two sections:
1) Site Qualification
2) Site follow-up
OFFICIAL DECERTIFICATION:
OCJS : Ohio Office of Criminal Justice Services
1. If the error rate of materials is higher than 4% then OCJS provides notice and get technical
support. From the date of E-mail received we get 12 months time and within 2 months we have to
correct the error and it will not get decertified.
2. Within 4 months we have to submit data with error less than 4%, if the material error rate is
higher than 4% OCJS will again give the notice.
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20. 3. Error of 4% cannot be submitted more than 3 times in a year otherwise
OCJS decertifies the vendors certificate.
4. For IBR : Once the director signs the decertification certificate that
vendor will be decertified in Ohio for IBR. And vendor gets
decertification notice.
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21. VENDOR RATINGS
Vendors or suppliers are given standing, status, or title according to their attainment of some level of
performance
It may take the form of a hierarchical ranking from poor to excellent
How vendors are rated
1.QUALITY
2.QUANTITY
3.PRICE
4.SOURCE
5.TIME
6.SERVICE
7.PLACE
NEED FOR
EFFECTIVENESS
INCREASED OUT
SOURCING
STRATEGY FOR
IMPROVEMENT
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23. Quality performance
It is the measure of material not in conformance with given specifications
A supplier can be judged for quality performance from the view point of rejected lots
This takes into account the no. of defects as well as seriousness of defects
Ex: If a supplier has supplied 100 pieces and 10 pieces are rejected from the lot, he has rating
of 90%.
(Number of lots accepted/Number of lots supplied)100 = weightage
(90/100) 100= 90%
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24. Delivery performance
It measures the promptness of vendor in keeping schedules of delivery, removing of rejected
materials and nature of response to other activities
Delivery performance thus can be made into 2 ways
1. ADHERENCE TO TIME SCHEDULE It can be calculated by following formula (No. of
deliveries made in time/Total no of scheduled deliveries) weightage
2. ADHERENCE TO QUANTITY SCHEDULE It can be measured by the following formula
(Quantity supplied/Scheduled delivery) weightage
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25. Price performance
It is another very important criteria for evaluating a vendor
It is a measure of price differential for the same product supplied by the different vendors
It can be evaluated as (Minimum price offered/vendor price) weightage
For example, assume that 160 lots were received during a year & 16 lots were rejected on account
of poor quality
Quality rating = (No. of lots accepted/No. of lots supplied)70 Quality rating = (144/160)70 =63
Adherence to time schedule (No. of deliveries made in time/ Total no of scheduled
deliveries)20
Adherence to quantity schedule (Quantity supplied / Scheduled delivery)20 Price
performance = (Minimum price offered / Vendor price)10
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26. Evaluation by q a department
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28. Approvedvendorlist
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29. Approved vendor list contains
1. Material ID number
2. Vendors name
3. Contract number
4. Vendor class
5. Material description
6. Vendor certificate ID
7. Product supplied by vendor
8. Last audit date
9. Specification approved such as date of approval by QA, QC & production department
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30. Reference
•http://www.pharmtech.com/how-develop-practical-and-compliant-vendor-qualification-
program-0?id=&sk=&date=&%0A% 09%09%09&pageID=4
•https://www.civilserviceindia.com/subject/Management/notes/vendor-evaluation-and-
audit.html
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