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VENDOR SELECTION IN
PHARMACEUTICAL INDUSTRY
By
AQSA FATIMA
M.Pharmacy 2nd semester
SULTAN UL ULOOM COLLLEGE
OF PHARMACY
Content :-
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 Definition

 Categories

 Benefits of certification

 Steps involve in certification

 cGMP requirement for vendor certification

 Standard procedure for conducting Quality Audit

 References
DEFINATION :-
Vendor certification is a supplier-customer partnership and can
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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 that a supplier’s product is produced

under controlled condition, resulting in consistent quality
conformance
Relationship Between Sponsor , Vendor and Supplier

VENDOR Supplier of
Contract (contract
manufacturer)
manufacturi
ng materials

VENDOR Supplier of
SPONSOR (contract labeling
labeler) materials

VENDOR Supplier of
(contract packaging
packager) materials
Characteristic of vendor categories
Vendors are mainly categorized in to four different parts:-

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
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Category – 2
 Well known suppliers of standard containers ,closures ,raw
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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.
Category – 3
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 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.
Category – 4
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 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.
Why to qualify vendors ?
 Used to determine if the vendor is appropriate for the scope of
9 work.

 Critical attributes of a partner relationship are Supplier or

customer commitment to a long term relationship.

 Information sharing.

 Joint agreement on specifications and performance standards.

 Performance measurement and feedback.

 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.
Benefits
10 of the Certification Process :
 Pharma firms will then not have to carry out their own quality
audit of the vendor.

 Vendors will be assured that customers of the product will not

expect 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
Vendor selection criteria:-
1. Quality
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2. Delivery
3. Performance history
4. Warranties and claim polices
5. Production facilities and capacity
6. Financial position
7. Price
8. Technical capability
9. Procedural compliance
10.Communication system
11.Reputation and position in industry
12.Desire for business
 13. Management and organization
14. Operating controls
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15. Repair service
16. Packaging ability
17. Labor relation record
18. Geographical location
19. Amount of past business
 Process Evaluation
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 The supplier must have suitable equipment to monitor the process.

 This equipment must be routinely calibrated and test methods validated.

Statistical process control techniques will usually be applied to demonstrate
that the process remained under control, within acceptable operating ranges,
throughout each production run.

 Process control data for several batches, chosen at random, should be

reviewed to confirm supplier compliance.
 vendor certification requires assurance that the supplier’s
process is under control and that the required quality standards
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are not being achieved by inspecting out substandard material.

 Increasingly, vendors are being requested to demonstrate that
their production processes are validated, especially for the
manufacture of bulk pharmaceutical chemicals.
 To demonstrate commitment to quality for other components,
some vendors have opted for ISO 9000 certification. This
certification does not necessarily assure consistent quality.
 Process and Specification Changes:-
 Any proposed changes must be clearly documented, with reasons and
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supporting data, and be reviewed and accepted by the customer prior to
introduction.

 Some changes may require customer evaluation and even FDA approval
before acceptance Changes require, prior review and agreement with the
supplier.

 For example, if the customer wants to make any replacement of a

packaging line, there would need to be discussions with the supplier of the
packaging components and the customer regarding changes
Customer Inspection

16After it has been confirmed that a supplier has a controlled

process, there usually will be a period when both parties evaluate
material quality and compare data.

This provides the needed assurance that supplier and customer

have comparable evaluation ability and minimizes future
potential for disagreements that are due to test results.

Vendor certification provides a strong basis for the application of

reduced testing by the customer.

If the supplier’s process is under control, evaluation by the

customer Is necessary to evaluate any changes during shipment.
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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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.
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 continuous monitoring program is also an essential component
BENEFIT :

Ability to evaluate the systems that the vendor uses

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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

SITE FOLLOW-UP :

 Carried out during the course of the project

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 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.
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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FACTORS TO BE CONSIDER WHEN PLANNING FOLLOW UP VISIT :

The relationship and experience with vendor

 The extent of vendor experience with the sponsor scope of work

 The sponsor’s regulatory commitments and compliance requirements

 The associated risks if project fails

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STANDARD PROCEDURE FOR CONDUCTING QUALITY AUDIT :

 Standard procedures for conducting the quality audit should be addressed in the
Vendor qualification program

 An audit cycle includes

1. The preparation of an audit
2. Performance of the audit
3. Reporting of the results of the audit
4. Audit closure or follow-up requirements

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 Step1: Preparing for the Audit
 Most critical part of the audit
 Takes longer to complete than performing the actual audit
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By putting more time into the preparation phase, the performance of the
audit will proceed smoothly.
 Effective audit plan will include the following elements:
 Purpose for the audit
 Scope of the audit
 Resources required of the sponsor to complete the audit
 Number of auditors
 Type of auditor or expertise required
 Assignment of a lead auditor to take responsibility for the audit.
 Reference documents to be used in planning and performing the audit
Step 2: Performing the Audit

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The performance of an audit begins with an introductory meeting wherein
all parties are introduced and the agenda is discussed

The performance of an audit is the collection of evidence and verification of

information through the following means:
 Interviews
 Examination of documents
 Direct observation of activities, processes, and conditions
 Review of raw data related to critical documents
Step 3: Reporting the Results
 Audit report should present a summary of the results or findings
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 This includes both positive findings and any areas identified for
improvement.

 Written summary prior to leaving the vendor’s facility allows the

vendor to begin working on the corrective action plans.

 Formal audit report is the product of the audit.

 Lead auditor is responsible for submitting the formal report in a

timely fashion.

 Final audit report should be prepared within 2 weeks from the

date of the audit
 Step 4: Audit Closure, Corrective Action, and Follow-Up

27  After audit , vendor is responsible for developing a corrective

action plan to address any weaknesses or deficiencies identified
by the sponsor’s auditors

 It is the sponsor’s responsibility to ensure that the corrective

actions are effective and implemented in a timely manner

 The sponsor must verify all commitments through the course of

routine monitoring
COMMON PITFALLS IN VENDOR QUALIFICATION

 Not establishing the habit of routine update meetings

 Overestimating the capabilities of the vendor

 Having a false sense of confidence that the vendor will maintain

itself at the same level throughout the contractual relationship

 Underestimating the resource-intensiveness of maintaining a

vendor Qualified

 Not switching vendors when appropriate

 Not dealing with situations of non-conformance in a timely and

effective manner

 Overburdening the supplier, as though you were its only client

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REFERANCE:-
1. Sidney H. Willing, "Good Manufacturing Practices for pharmaceuticals",
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Drugs and Pharm. Sci. Series, Vol. 109, Marcel Dekker Inc., N.Y.

2. Charles A. Weber, John R. Current and W.C. Benton “Vendor selection

criteria and methods” European Journal of Operational Research 50 (1991) 2-
18 North-Holland, Faculty of Management Sciences, College of Business,
The Ohio State University, 1775 College Road, Columbus, OH 43210-1399,
USA
3. Elizabeth M. Troll, Karen L. Hughes “The Vendor Qualification Program”
(2004) CHP-10,MARCEL DEKKER Inc.
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