CHECK LIST FOR

VENDOR
QUALIFICATION

By: MANSI GUPTA

DEPARTMENT OF PHARMACEUTICS
1
18/MPH/DPSRU/18
2nd semester
2 VENDOR QUALIFICATION
 VENDOR
• Vendor or Supplier is the seller of the API to manufacturer of
finished dosage form.
 VENDOR QUALIFICATION
• 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.
• It is the combination of activities required to ensure that a
vendor will meet the professional and regulatory expectation of
the sponsor.
3 VENDOR SELECTION CRITERIA

 Quality
 Delivery
 Performance history
 Warranties and claim policies
 Production facilities and capacities
 Financial position
 Price
 Technical capability
4
CONT…
 Communication system
 Reputation and position in industry
 Desire for business
 Management and organization
 Repair service
 Packaging ability
 Labour relation record
 Geographical location
5
VENDOR QUALIFICATION
 Concerned Department Informed to Purchase Department
for Material through IOM
 QC Provide the Specification QA Provide the Questionnaire
to Purchase Department
 Purchase Department Send the Questionnaire to the
Vendor
 Filled Questionnaire & Sample Received Back From Vendor
to Purchase / PPIC Department
 Filled Questionnaire & Sample Send to QA / QC for
Evaluation
 Rejection/ approval
 Vendor audit
6
VENDOR SELECTION
 The supplier selection process starts with the definition of
the user requirements for the materials(s) within scope.
The user requirement specifications provided to purchasing
should contain as a minimum the following information:
1. Name of the product (including formulae)
2. Material specifications
3. Quantity required
7
VENDOR SELECTION
 The following information from the supplier should be requested
as part of the Suppliers Questionnaire:
 Specifications
 Manufacturing/packaging/labelling details
 Materials Safety Data Sheets
 Logistic information (lead time to produce, delivery time, etc)
 Certificates regarding Quality system, residual solvents, etc...
 BSE/TSE evaluation
 Analytical test method
8
VENDOR SELECTION
 It is a pre-requisite to demonstrate that the material
provided by the potential supplier meets the specification
as defined, and compliance to the specifications should be
verified by analytical testing of a sample.
 Following different dimensions could be assessed:
1. Assurance of Supply
2. Quality & Regulatory compliance
3. Cost/Procurement aspects
4. Technical/Innovation
5. Communication capabilities & responsiveness
9  Assurance of Supply: Assurance of supply is an essential
element in order to guarantee appropriate supply chain
management in the organisation. To obtain a picture as complete
as possible following aspects should be taken into consideration:
 Capacity (Scale equipment, batch size, chemistry experience,
etc....)
 Safety/Health/Environmental Risk
 Inventory management
 Financial solvency/business stability
 REACH requirements
 Delivery performance
 Supply chain management of the material in question
  Quality and regulatory compliance:
10 1. cGMP Compliance & regulatory track record
2. Recalls & Complaints
3. Change/Deviation Management
4. Materials management controls
5. Quality Management Systems
6. Quality Agreement
7. Quality Culture
8. Production Facilities & Equipment
9. Product Quality Review
10.Process Validation approach
11.Documentation standard
11
 Procurement/ cost:
1. Cost Management
2. Presence in Low Cost Countries (Emerging markets)
3. Ability to achieve the target price
  Innovation/Technical:
12
1. Plant capabilities
2. Laboratory capabilities
3. Technical skills/ Staff Qualifications
4. Control systems
5. Development capability
6. Process development expertise
7. Project management
8. Willingness to innovate
13
 Responsiveness & Communication:
1. Rapidity project assessment
2. Resource availability
3. Flexibility (Attitude)
4. Functional contacts definition
5. Openness
6. Ease of communication
7. Pro-activeness