VENDOR CERTIFICATION

Prepared By:- Ketan Patel

M.Pharm – Sem - I

ID : 11/MPQA/08

Department of Quality Assurance

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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 that a supplier’s product is produced under controlled condition, resulting in consistent quality conformance

DEFINATION :-

SPONSOR

VENDOR(contract

manufacturer)

VENDOR(contract labeler)

VENDOR(contract packager)

Supplier of manufacturing materials

Supplier of labeling

materials

Supplier of packaging materials

Contract

Contract

Relationship Between Sponsor , Vendor and Supplier

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

CHARACTERISTIC OF VENDOR CATEGORIES

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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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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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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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WHY TO QUALIFY VENDORS ? Used to determine if the vendor is appropriate for the scope of

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.

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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

BENEFITS OF THE CERTIFICATION PROCESS :

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SUPPLIER SELECTION

Supplier’s history in terms of quality, delivery, and support service as well as the importance of the specific material to the business.

Chance of success with a supplier who already has a high commitment to quality and customer service.

Several key steps involved in the certification process:-

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INITIAL SUPPLIER CONTACTS

The proposed process will be discussed with the

supplier .After agreement on the concept ,which

must include senior management ,the individual

components of the process can be studied and

adapted for mutual satisfaction.

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Supplier process

Specifications

Process evaluation

Process Elements :

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PROCESS ELEMENTS

Supplier process:-

Some or all of the customer vendor certification team should visit

the supplier’s plant to gain an understanding of the production

process and the key elements which impact on the achievement of

quality standards.

Where a material may be supplied from more than one plant of the

supplier, each plant must be treated as a separate entity for

certification purposes.

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2. Specifications:- A detailed review should be made of product specifications

with particular reference to legal requirements (compendia,

FDA, etc.) and fitness for use.

Increasing the level of assurance on more critical parameters.

This can be particularly important with packaging components

where improvements in some areas can dramatically impact on

line speeds and efficiency and with particle size of powder

ingredients. Obviously test methods should, where possible, be

identical. Where this is not possible, equivalence must be

demonstrated.

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The following information from the supplier should be

requested as part of the Suppliers Questionnaire

Specifications

Manufacturing/packaging/labelling details

Materials Safety Data Sheets

Logistic information (lead time to produce, delivery time, etc)

Certificates regarding Quality system

Analytical test method

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Vendor selection criteria:-

1. Quality

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

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13. Management and organization

14. Operating controls

15. Repair service

16. Packaging ability

17. Labor relation record

18. Geographical location

19. Amount of past business

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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.

Process Evaluation

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vendor certification requires assurance that the supplier’s

process is under control and that the required quality standards

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.

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Any proposed changes must be clearly documented, with

reasons and 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

Process and Specification Changes:-

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Customer Inspection

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.

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Supplier ReportingSince vendor certification is a partnership, it is important that both supplier

and customer are kept informed of each other’s difficulties.

The supplier must notify the customer of any typical situations or process

deviations prior to shipping material so that any additional testing or

evaluations may be performed.

Supplier should also provide certificates of compliance or certificates of

analysis for every batch—formatted in a manner which is acceptable to the

customer.

The customer should also provide feedback to the supplier with respect to

compliance with specification, performance in use, and delivery service.

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.

continuous monitoring program is also an essential component 25

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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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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

FACTORS TO BE CONSIDER WHEN PLANNING FOLLOW UP VISIT :

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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

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

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

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Step 2: Performing the Audit

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

 

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Step 3: Reporting the Results Audit report should present a summary of the results or findings

of the audit.

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

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Step 4: Audit Closure, Corrective Action, and Follow-Up

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

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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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REFERENCE:-

1. Sidney H. Willing, "Good Manufacturing Practices for pharmaceuticals",

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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THANK YOU……