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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DEFINATION :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 suppliers product is produced under controlled condition, resulting in consistent quality conformance
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Relationship Between Sponsor , Vendor and Supplier

VENDOR (contract manufacturer)

Contract

Supplier of manufacturi ng materials

SPONSOR

VENDOR (contract labeler)

Supplier of labeling materials

VENDOR (contract packager)

Supplier of packaging 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 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 with category 2 vendors. these vendors is greater than

 Advanced monitoring program and an annual audit schedule are recommended. 7

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 suppliers manufacturing capability, quality, cost, and development.
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These attributes will vary depending on the status of the supplier-customer relationship.

BENEFITS 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
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Several key steps involved in the certification process:-

SUPPLIER SELECTION


Suppliers 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.

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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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Process Elements :
Supplier process Specifications Process evaluation

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PROCESS ELEMENTS
Supplier process: Some or all of the customer vendor certification team should visit the suppliers 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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Process Evaluation
 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.
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 Process control data for several batches, chosen at random, should be reviewed to confirm supplier compliance.

vendor certification requires assurance that the suppliers 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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Process and Specification Changes: 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
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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 suppliers process is under control, evaluation by the customer Is necessary to evaluate any changes during shipment.
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Supplier Reporting
Since vendor certification is a partnership, it is important that both supplier and customer are kept informed of each others 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 batchformatted in a manner which is acceptable to the customer.

 The customer should also provide feedback to the supplier with respect23 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 customers 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
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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
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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 sponsors 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. 2. 3. 4. The preparation of an audit Performance of the audit Reporting of the results of the audit 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 vendors 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 sponsors auditors

 It is the sponsors 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
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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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REFERENCE:1. Sidney H. Willing, "Good Manufacturing Practices for pharmaceuticals", Drugs and Pharm. Sci. Series, Vol. 109, Marcel Dekker Inc., N.Y.

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Charles A. Weber, John R. Current and W.C. Benton Vendor selection criteria and methods European Journal of Operational Research 50 (1991) 218 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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