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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 ValidationTypes of ValidationWho Is Vendor Vendor ValidationWhy Vendor ValidationSteps in Vendor ValidationCase 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 VendorBased 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 RequiredQuestionnaire - 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 ManagementQuality & Regulatory Compliance- cGMP / Regulatory - Recall and complaints - Documentation/ Quality control- Process Validation

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Cont…

Procurement / cost - Cost management - Emerging market - Target PriceTechnical / Innovation support - Plant Capability - Business problem resolving capability - Technical skill /Staff Qualification - Control systemResponsiveness 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

Parameter Raw Material TypeAPI Critical Raw

materialNon-critical Raw

material

TSE/BSE Assessment

Y Y Y

Tanker cleaning Assessment

Y Y Y

Supplier/Mfg Questionnaire

Y Y Y

Mfg Audit Y Y* NHistorical Performance

Y Y Y

Y - Yes mandatory with raw materialN- NoY*- If demanded by manufacturer.

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Cont….

Parameter Raw Material Type

API Critical Raw Material

Non-Critical Raw Material

cGMP Compliance History

Y Y* N

3rd Party Certification

Y Y* N

Contract Agreement

Y Y Y

Quality Agreement

Y Y Y

Y - Yes mandatory with raw materialN- NoY*- If demanded by manufacturer.

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08.Change control and Production Assessment

Change control and Production assessment follow five main steps-

1. Initiation of Change2. Execution of Change3. Evaluation of Change4. Closure of the Temporary Change Control

Package5. 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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CasesThe following are some cases which

due to violations of GMP1. 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 company

Date observation Corrective action taken

01 Vendor unlimited corporation ,Dubuque

18 Nov 2011 Certificate of Analysis (CoA) from your stopper suppliers without conducting adequate vendor qualification.

Vendor validation required

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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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