VENDOR VALIDATION

Present By - Mr. Akshay G. Kakde

M. Pharm IInd sem
Guided By - Dr.S.S.Bhujbal
Dr. D. Y. Patil IPSR Pimpri,411018
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Content
 Introduction
 Importance of Validation
 Types of Validation
 Who Is Vendor
 Vendor Validation
 Why Vendor Validation
 Steps in Vendor Validation
 Case study
 Conclusion
 Reference

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Introduction

Validation

“Establishing documented evidence which

provides a high degree of assurance that a specific
process will consistently produce a product
meeting its predetermined specifications and
process that give consistent results.”

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Importance of Validation
 It ensure conformation to cGMP
requirements.
 It helps to identify root cause of problem.
 It maintains a company’s public image and
also that of the health care community.
 It documents that the final product has
fallowed reliable manufacturing processes.
 It documents that the process or activity in
control.

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Types Of Validation
 Following are five types of validation
1)Process Validation
2)Analytical Validation
3)Equipment Validation
4)Cleaning Validation
5)Vendor validation
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Who is Vendor

 Definition : Vendor
“Is the authorised seller or the supplier
who provide the raw material(API),packaging
material and equipment to the pharmaceutical
organization for the production good quality of
product”

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Vendor validation

 It is documented evidence and process of

evaluating and approving potential supplier
by quantitative assessment.

 The purpose of supplier evaluation is ensure

a portfolio of best in class supplier is
available for use.

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Why vendor validation??
 Used to determine if the vendor is appropriate
for the scope of work.
 Supplier or customer commitment to a long
term relationship.
 Information sharing.
 Joint agreement on specifications and
performance standards.
 Performance measurement and feedback.
 Customer confidence

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Steps in Vendor Validation
 01. Requirement for validation
 02. Regulatory Agencies
 03. Flow Process for sample analysis
 04.Classification of Vendor
 05. Selection of Vendor
 06. Due Diligence Process
 07. Quality Assessment of Vendor
 08. Change control and Production
Assessment
 09. Monitoring and Evaluation

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01 Requirement for vendor validation
Documents
- User Requirement Specification(URS).
- Vendor Assessment Questionnaire.
- Approved vendor list.

 Responsibility
- Purchase head (identify potential supplier).
- Production (URS and Plant Trials)
- QC (check URS , test sample and trial material)
- QA (Monitor, approve URS, periodic evaluation)
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Cont…
 Validation team
-Personnel from:-
- QC department
- QA department
- Production department
- Store department
- Engineering department
- Regulatory department
- Purchase department

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02. Regulatory Agencies
 Following are Regulatory Agencies
1. USFDA ( United State Food And Drug
Administration)
2. WHO (World Health Organization)
3. FDA (Food And Drug Administration)

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03.Flow Process for sample analysis
Supplier selection
URS
Questionnaire
Receive sample form supplier with COA

Analysis / testing as per COA & URS

After passing analytical testing Plant Trials

Trial batches to QC for analysis

Satisfactory result / analytical / trial / meeting with standard
specification
Proceed to next step of vendor validation.

fig. flow of analysis and approving vendor sample

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04.Classification of Vendor
 Based on Performance and Quality of
material
 Four types
1) Fully Satisfactory
2) Limited or mainly Satisfactory
3) Partially Satisfactory
4) Not Satisfactory

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05. Selection criteria
 URS
- Name of Product
- Material Specification
- Quantity Required
 Questionnaire
- Raw material specifications
- Mfg /Packaging/Labeling Detail
- MSDS
- Certification from standard agencies
- Analytical test method

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Cont…
 Assurance of supply-
- Capacity
- Safely/ Health / environment risk
- Business stability
- Delivery performance
- Supply chain Management
 Quality & Regulatory Compliance
- cGMP / Regulatory
- Recall and complaints
- Documentation/ Quality control
- Process Validation 16
 Cont…
 Procurement / cost
- Cost management
- Emerging market
- Target Price
 Technical / Innovation support
- Plant Capability
- Business problem resolving capability
- Technical skill /Staff Qualification
- Control system
 Responsiveness and communication
- Resource availability
- Ease of communication

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06. Due Diligence Process
 Following things should be check
 General material information
 Quality system
 Plant visit
 Documentation
 Manufacturing Process
 Physical properties of material
 Analytical and stability profile
 Regulatory
 Intellectual property
 Safety/ environmental / health
 Economics

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07. Quality Assessment of Vendor
 Basically it depend on the types of
material required from vendor

 Following types

1) API

2) Critical raw Material

3) Non-critical raw Material

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Table vendor quality assessment
Y - Yes mandatory with raw material
N- No
Y*- If demanded by manufacturer.
Parameter Raw Material Type
API Critical Raw Non-critical Raw
material material
TSE/BSE Y Y Y
Assessment
Tanker cleaning Y Y Y
Assessment
Supplier/Mfg Y Y Y
Questionnaire
Mfg Audit Y Y* N
Historical Y Y Y
Performance
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Cont….
Y - Yes mandatory with raw material
N- No
Y*- If demanded by manufacturer.
Parameter Raw Material Type
API Critical Raw Non-Critical Raw
Material Material
cGMP Y Y* N
Compliance
History
3rd Party Y Y* N
Certification
Contract Y Y Y
Agreement
Quality Y Y Y
Agreement
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08.Change control and Production
Assessment
 Change control and Production
assessment follow five main steps-
1. Initiation of Change
2. Execution of Change
3. Evaluation of Change
4. Closure of the Temporary Change Control
Package
5. Preparation for Ongoing Monitoring

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09.Monitoring and Evaluation

 All documentation and qualification and

approved order of raw material.

 Periodic evaluation and monitoring

 Responsibility

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Cases
The following are some cases which
due to violations of GMP
1. The gentamicin sulphate case in which
unknown contamination leads to total
around 65 death in USA in 1994 and
1999.
2. The heparin case in 2008, causing
around 150 fatalities in the US due to
deliberate contamination of the API with
a Bogus substance.
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Warning letter

Sr. no Name of Date observation Corrective

company action taken
01 Vendor 18 Nov 2011 Certificate of Vendor
unlimited Analysis validation
corporation (CoA) from required
,Dubuque your stopper
suppliers
without
conducting
adequate
vendor
qualification.

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Conclusion
 Vendor plays very important role in manufacturing of
product.
 Approved vendor must have license from regulatory
agencies
 All the documents, reports and contracts must have
approved by authority body from the organization.
 Contract must have approved from both the parties
vendor and company.
 COA and IHS report must be in the specification limit
and complies with standard.
 The classification of vendor is accordingly their
satisfactory results of material.
 To avoid complaints and product related problem vendor
must be validated which gives better result and save
time and money.
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References
1. James Agalloco and Frederick J. Carleton, Validation of
Pharmaceutical Processes, Third Edition, Page No-529-
540
2. Syed Imtiaz Haider, Validation standard Oprating
Procedures, Second Edition, Informa healthcare, page
no-461-466
3. M.A. Potdar , Current Good Manufacturing Practices,
Pharma-Med Press, Hyderabad.
4. Dr. Sohan S. Chitlange, Dr. Pravin D. Chaudhari,
Pharmaceutical Validation , Pharma-tree educations,
SPD Pvt.Ltd. Akrudi, Pune. Page No-7.1-7.9
5. www. USFDA.com / Warning letter / general warning
letter. Date – March 14,2017
6. http://economictimes.indiatimes.com/topic/vendor-
validtion date- march15,2017

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Questions

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