vendor certification

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detail of vendor and procedure of giving certification

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Presentation Transcript

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Prepared by Miss Ladva Bhakti J. M.Pharm – Sem - III Department of Quality Assurance SJTPC,Rajkot . a seminar on VENDOR CERTIFICATION 2 Guided by Mrs.Jagruti P. vaghela (Assistant professor) SJTPC,Rajkot . 7-Feb-12

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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 3 7-Feb-12

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4 4 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. 7-Feb-12

This procedure aim to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will get the role of each department in process certify. :

This procedure aim to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will get the role of each department in process certify. 5 7-Feb-12

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7-Feb-12 6 This SOP describes the procedure to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.

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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 SPONSER,VENDOR AND SUPPLIER . 7 7-Feb-12

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8 Vendors are mainly categorized into 4 different parts Category I Category II Category III Category IV 7-Feb-12

CATEGORY – 1 :

CATEGORY – 1 9 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. 7-Feb-12

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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. 10 CATEGORY – 2 7-Feb-12

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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. 11 CATEGORY – 3 7-Feb-12

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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. 12 CATEGORY – 4 7-Feb-12

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13 CATEGORY OF VENDOR TYPE OF VENDOR SUPPLIER MONITORIG NEEDED Category 1 Supplier of manufacturing supplies i.e. catalog items Supplier of customized manufacturing supplies Minimal Category 2 Raw material , excipients supplier Container/closure supplier Enhanced Category 3 Contract manufacturer-commercial product Labeling supplier Contract laboratory Advance Category 4 Contract manufacturer -clinical trial supplies Contract packager Contract manufacturer-API Intense 7-Feb-12

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14 Used to determine if 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. 7-Feb-12

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15 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. 7-Feb-12

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16 16 Need to source new vendor is identified QA, Technical, Procurement liaise for vendor Identify possible vendors Send Supplier Questionnaire Purchase, Sampling and Testing Discussion to proceed NO Phase 2: required YES General Vendor Audit Accepted YES NO Phase 3: Item specification Evaluation Accepted Phase 4: YES NO Accepted NO Vendor certification YES 7-Feb-12

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17 CUSTOMER TEAMS : Team includes representative from manufacturing, package engineering , purchasing and quality assurance team. Also from some other disciplines like finance, research and development. Functions Define the objectives and potential benefits. Write a process that can be used as a basis for discussion with suppliers. 7-Feb-12

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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. The proposed process will be discussed with the supplier. After agreement on the concept the individual components of the process can be reviewed and adapted for mutual satisfaction. 18 7-Feb-12

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Process evaluation. Supplier process. Specifications. Customer 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. 19 7-Feb-12

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Detailed review should be made of product specifications with particular reference to legal requirements (compendia, FDA etc.) Done to increase the level of assurance on more critical parameters. Mainly important with packaging components and with particle size of powder ingredients. 20 7-Feb-12

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Supplier must have suitable equipment to monitor the process and this equipment must be routinely calibrated and test methods validated. Statistical process control techniques should be applied to demonstrate that the process remained under control, within acceptable operating ranges, throughout each production run. 21 7-Feb-12

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22 7-Feb-12 Process control data for several batches should be choosen at random and reviewed to confirm supplier compliance. Generally vendors are being requested to demonstrate that their production processes are validated, especially for the manufacture of bulk pharmaceutical chemicals.

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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 .(1) 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. 23 7-Feb-12

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After it has been confimed 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. 24 7-Feb-12

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Since 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. 25 7-Feb-12

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7-Feb-12 26 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.

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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. 27 7-Feb-12

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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. Continuous monitoring program is also an essential component. 7-Feb-12

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Purpose Responsibility Procedure Vendor certification (5) 1 selection of vendors 2 Review of historocal data 3 Site audit 4 Recommendations 5 Decision on certification 6 Steps after certification 7 Recertification

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BENEFITS 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, they are requested corrective action prior to initiating the work. RISKS 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. 30 7-Feb-12

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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 Lack of adherence to standard operating procedures. Lack of appropriate documentation of trainining , physical structure of the facility. If standard operating procedure (SOP) or data integrity questions arise during the course of the study or project. 31 7-Feb-12

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32 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. RISKS Any corrections that may be needed will not occur in a timely manner. Due to late identification of deficiencies will delay the project. 7-Feb-12

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The relationship and experience with vendor. The extent of vendor experience with the sponsor subject of work. The sponsor’s regulatory commitments and compliance requirements. The associated risks if project fails. 33 7-Feb-12 FACTORS TO BE CONSIDERED WHEN PLANNING FOLLOW UP VISIT.

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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. 34 7-Feb-12

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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. 35 7-Feb-12

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7-Feb-12 36 EFFECTIVE AUDIT PLAN WILL INCLUDE THE FOLLOWING ELEMENTS (5) Purpose and 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 where in 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. 37 7-Feb-12

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38 AN QUALITY ASSESSMENT QUESTIONNAIRE MUST COVER THE UNDER LISTED TOPICS General. Organization & Personnel. Facilities Equipment. System Integration. Development Plan. Test Plan. Configuration Management. 7-Feb-12 Customer Support. Product Security. Change Control. Quality Systems. Document Control. Program Documentation. Documentation Management

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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. 39 7-Feb-12

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STEP 4: AUDITCLOSURE,CORRECTIVEACTION,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. 40 7-Feb-12

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41 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. 7-Feb-12

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42 Overburdening the supplier, as though you were its only client. Telling the vendor what to do rather than asking the vendor what is possible. Underestimating the amount of time and effort it takes to initially qualify a vendor. Failing to understand how systems work within the vendor’s organization. Failing to periodically authenticate raw data provided by the supplier. 7-Feb-12

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Q. Write short note on vendor certification. 43 7-Feb-12

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GMP for pharmaceuticals, Marcel Dekker by Sidney H. Willig , Volume 109. Compliance handbook for pharmaceuticals, medical devices and biologics by Carmen medina. Marcel Dekker – Elizabeth M. Troll , Karen L. Hugh. 4 cGMP for pharmaceuticals by M.A. Potdar . 5 Validation standard operating procedures by Syed Imtiaz Haider , second edition. 44 7-Feb-12

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THANK YOU 45 7-Feb-12

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