in pharmaceutical industry how the cerification of vender is going to carry out

1. VENDOR CERTIFICATION
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PRESENTED BY:
RAJESH LAXMAN
RAUT
M.Pharm I (QA)
Guided by
RAM SAKHARE
School Of Pharmacy
Swami Ramanand Teerth Marathwada University Nanded

2. Content:
• Definition
• Categories
• Benefits of certification
• Steps involve in certification
• cGMP requirement for vendor certification
• Standard procedure for conducting Quality Audit
• References
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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 the supplier’s product is produced
under controlled condition ,resulting in consistent quality
conformance

4. SPONSOR
VENDOR
(contract
manufacturer)
VENDOR
(contract
labeler)
VENDOR
(contract
packager)
Supplier of
manufacturing
materials
Supplier of
labeling
materials
Supplier of
packaging
materials
contract
contract
contract
Relationship between sponsor , vendor and supplier
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Vendors are mainly categorized into 4 different categories,
CATEGORY – 1
• generally regarded as EXPERTS
• ‘short lived’ in development cycle
• contracted to perform limited scope of work
• “minimal monitoring”
• Example: Supplier customizes a formulation tank. Sponsor
reviews and approves the blueprints prior to manufacturing. Then
IQ and OQ is planned upon receipt to verify acceptability

6. CATEGORY – 2
• 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
• Example: Well-known supplier of containers/closures supplies
multiple lots per year of vials to the sponsor. The sponsor has no
historical quality concerns with the supplier. Testing will be conducted
upon receipt to verify acceptability of materials.
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7. CATEGORY – 3
• Category 3 vendors may be category 2 vendors who are experiencing
quality issues with current incoming inventory or have shown a trend of
non-conformance over the last 12 months
• Can be contract laboratory operations that provide routine analysis,
sometimes in large quantities
• The risk of non-conformance of these vendors is greater than with
category 2 vendors
• advanced monitoring program and an annual audit schedule are
recommended.
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8. CATEGORY – 4
• They are sole-source API manufactures
• intense monitoring is suggested in this category
• Examples: A contract manufacture is supplying clinical trials supplies.
Since this is the first time that the product is being manufactured at a
larger scale, the sponsor has elected to be on site for each event for
monitoring and consultation
• 100% of the lot will be visually inspected for release upon receipt by
the sponsor
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CATEGORY OF
VANDOR
TYPE OF VENDOR
SUPPLIER
MONITORIG NEEDED
Category 1
1. Supplier of
manufacturing
supplies i.e. catalog
items
2. Supplier of customized
manufacturing
supplies
Minimal
Category 2
1. Raw material ,
excipients supplier
2. Container/closure
supplier
Enhanced
Category 3
Similar to category 2
vendors but risk of non
conformance is more
Advance
Category 4
1. Contract manufacturer-
clinical trial supplies
2. Contract packager
3. Contract manufacturer-
API
Intense
ComparativeReview

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• Used to determine the vendor is appropriate for the scope of work
• Critical attributes of a partner relationship are
1) Supplier or customer commitment to a long term relationship
2) Information sharing
3) Joint agreement on specifications and performance standards
4) Performance measurement and feedback
5) Customer confidence in the supplier’s manufacturing capability
quality, cost, and development
• These attributes will vary depending on the status of the supplier-
customer relationship

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• Pharma firms not have to carry out their own quality audit of the vendor
• Vendors will give assurance that customers of the product will not have
to carry out their own quality audit of their systems or products
• Rapid and efficient qualification process prior to sale and
delivery/acceptance of a system
• Reduced cost

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ESTABLISHMENT OF TEAMS :
• Team includes representative from manufacturing ,package
engineering , purchasing and quality assurance team
• Also from some other disciplines like finance, research and
development
• Function :
1) define the objectives and potential benefits
2) write a process that can be used as a basis for discussion with
suppliers

13. 1.SELECTION OF VENDER TO BE CERTIFIED:
The selection of Vender to be certified should be jointly made by the head of
Purchasing and Production and Quality assurance manager
Vender certification criteria:
O Experience with similar size project and similar size company
O Experience with similar type of Business (market, Chanel, technology)
O Stability: Financial health and employee stability
O Cultural fit: Personalities and work style
O Well defined Project management methodology
O Post implementation relationship with previous customer
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14. 2. REVIEW OF HISTORICAL DATA AND TEST RESULT:
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Summarize the quality data of batches delivered during the last 3 years
and prepare trend analysis.
Report deviations with regard to normal failure levels, out of specification
situations, and corrective action quality assurance managers shall
review the trend
3.SITE AUDIT:
The quality assurance manager or the system in charge may perform an on site
audit should specifically
DETERMINE:
O ACCURACY O PRECSION O RELIBILITY OF TEST
O INSPECTION DATA OF VENDER
REVIEW:
O PROCESS REPRODUCIBILITY
O BATCH RECORD FOR PROCESS VARIATION

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Perform general GMP compliance inspection .
Review the Potential for contamination and mix-ups thoroughly.
Ensure that Vender in-process controls include the use of statistical
process control critical product Parameter that are significant and may
affect the final product quality.
Ensures the absence of significant online problems.
4.RECOMENDATION:
It is not essential to perform on site inspection
As an alternative, evaluation ,questionnaires can be used
Vendors can also be certified based on an extensive review of historical analytical
inspection data and their performance over the last 3 years.
Alternatively, third party audits may be conducted for a predefined period
Cont….

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5.DECISION ON CERTIFICATION:
The data obtained as a result of these reviewed by the QA manager and sent for
approval to quality control production and purchasing final release must be
authorised by quality controll
6. STEP AFTER CERTIFICATION:
After vender approval quality control or quality assurance will reduce the no. of
tests and inspection of incomming goods as agreed in certification report .
Eg. One out of ten batches
For packaging material certification, it is sufficient to review the result of three
suppliers
If during this process of varification no discrepancies appear the varification
may be discontinued
For incomplete certification a provisional classification report shall be published
by QA manager for components
Material to be used in production without complete testing must be supported
with acceptable certificates of analysis by manufacturers

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Active ingredient should be checked for their identity
All deviations regarding Purchased material encountered by production
must be reported to quality assurance manager for reference to
manufacturer or supplier
7.RECERTIFICATION:
O Recertification of the active and excipient manufacturer may be performed on
request
O Recertification can be requested by quality control production
O The certification valid for period determined by the QA manager
O Certification of packaging material is valid for 5 years

18. Decertification
• Certification results in a high level of reliance on the supplier : reduced
incoming inspection, reduced inventories, higher output
• 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 reestablish certification
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19. CGMP REQUIREMENTS FOR VENDOR QUALIFICATION
Divided into two sections
1) Site Qualification
2) Site follow-up
Site Qualification :
• Vendors selected are evaluated for compliance with the appropriate set of
regulations
• The results of the audit will be reviewed and the need for a ‘‘site follow-up
visit’’
• Site qualification visits are generally performed on a cyclical basis; at least
once every 24 months is suggested unless the supplier becomes
problematic
• continuous monitoring program is also an essential component
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20. BENEFIT :
• ability to evaluate the systems that the vendor uses to produce regulated
work product.
• If a systems ‘‘gap’’ is detected in any of the quality systems the sponsor
should request corrective action prior to initiating the work
RISK :
• Here the systems review is theoretical, not practical
• No ‘‘real’’ data can be reviewed prior to initiating the work
• The systems cannot be adequately tested without ‘‘real’’ data
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21. SITE FOLLOW-UP :
• Carried out during the course of the project
• Examples of issues that will usually result in site follow-up include
1) lack of adherence to standard operating procedures
2) lack of appropriate documentation of training, major renovations to the
physical structure of the facility
3) if standard operating procedure (SOP) or data integrity questions arise
during the course of the study or project
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BENEFIT :
• Ability to evaluate the systems that the vendor uses to produce regulated
work product in ‘‘real time’’ with data generated for a specific project
RISK :
• Any corrections that may be needed will not occur in a timely manner
• due to late identification of deficiencies will delay the project

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24. REFRENCES
• GMP for pharmaceuticals ( a plan for total quality control from
manufacturer to consumer ) volume-109.5th
edition Sidney h. Willing
• Laboratory auditing for quality regulatory compliance ,volume 150,
Donald c .signer et.al
• “Pharmaceutical Process validation” second edition, revised and
expanded; Marcel Dekker series; Pg.No.347-372.Elizabeth M. Troll ,
Karen L. Hughes.
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