vendor validation by akshay kakde
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Transcript of vendor validation by akshay kakde
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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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