VENDOR QUALIFICATION 1.pptx

Vendor ,types , selection of vendor, categories of vendor, certification of vendors

1. VENDOR QUALIFICATION Presented by:Anusha.S 1 st sem M.pharmacy QUALITY ASSURANCE DEPT

2. CONTENT: Definition Types of Vendor Qualification. Classification. Category of Vendor. Vendor selection steps. Procedure for vendor approval. Evaluation of vendor. Vendor certification.

3. DEFINITION : VENDOR : A vendor is a general term used to describe any supplier of goods or services. A vendor sells products or services to another company or individual. which has been identified as a potential source of supply for a specific material . The non-manufacturing vendor can only purchase material from the approved manufacturer as directed by the Buyer. QUALIFICATION : Qualify the appropriate vendor.

4. VENDOR QUALIFICATION: Vendor qualification is the process by which a vendor is assessed to determine, if it can provide the required goods or services to the standards that the purchasing company requires. This article explains about the detailed procedure for qualifying raw material vendors, packaging vendors and service providers. MANUFACTURER: is the company that synthesizes or produces the product. is responsible for all aspects of manufacture and quality control of the material. in the case of active manufacturers the manufacturer is responsible for the provision and maintenance of a Master Files.

5. SUPPLY CHAIN : If a company makes a product from parts purchased from suppliers, and those products are sold to customers, then it is a SUPPLY CHAIN. Some supply chains are simple, while others are rather complicated. The complexity of the supply chain will vary with the size of the business , and numbers of items that are manufactured. To ensure that the supply chain is operating as efficient as possible and generating the highest level of customer satisfaction at the lowest cost, companies have adopted SUPPLY CHAIN MANAGEMENT processes and associated technology .

6. Supply Chain Management has three levels of activities that different parts of the company will focus on: STRATEGIC TACTICAL OPERATIONAL

7. Types of vendors/suppliers: There are many different types of vendors that all have slightly different roles in supplying goods and services. These are few common examples: Service and maintenance providers perform services. Manufacturers make goods from raw materials. Wholesalers sell goods to other businesses. Retailers sell goods to individual consumers.

8. CLASSIFICATION OF VENDORS: Business to costumer: The B2C type of vendor sells directly to the consumer. They sell generally completed products to the end-user or even product components. It can be a retail store, such as the pharmacy store or it can also be a retailer, acting as a specialty vendor for the end consumer. A vendor can be an online retailer or even someone selling medicine on app. Some vendors even specialize in providing consumer services. Vendors provide a wide-ranging volume of products to the end consumer.

9. 2) BUSSINESS TO BUSSINESS: A B2B vendor is one that sells primarily to other vendors. An example of a B2B vendor is RAW MATERIAL, which sell raw material to manufacturing units, or manufacturers, such as cipla which sell components to other units. The items are being sold to businesses and will, in turn, generally be stored in inventory either for a short or long period of time (depending on the product). Example: Paracetamol is API transferred by on vendor to other for manufacturing of other drug product such as combiflame which is combination of paracetamol + Ibuprofen.

10. VENDOR CATEGORIES: CATEGORY 1: Generally regarded as EXPERT Short lived in development cycle. Contracted to perform limited scope of work. Minimal monitoring. Example: Supplier customises the formulation tank. Sponsor reviews and approves the blueprint prior to manufacturing. Then IQ and OQ is planned upon receipt to verify acceptability.

11. Category 2: Well known supplier of standard container, closures, raw material and excipient. Certified to an ISO9000 Quality Management System. Enhance monitoring is suggested. Example: Well known supplier of standard container/closure supplies multiple lots of vials per year to sponsor. The sponsor has no historical concern with the supplier testing will be conducted upon receipt to verify acceptability of material .

12. Category 3: Category 3 vendor may be category 2 vendor who are experiencing quality issues with current incoming inventory or have shown a trend of non-conformance over the last 12 month. Can be contract laboratory operation that provide routine analysis, sometimes in large quantities. The risk of non-conformance of this vendor is greater than with category 2 vendors. Advance monitoring and annual audit schedule are recommended .

13. Category 4: They are sole-source API manufactures. Intense monitoring is suggested in this category. 100% of lot will be visually inspected for release upon receipt of sponsor. Examples: The contract manufacturer is supplying clinical trial supplies. For the first time product is being manufactured at larger scale, the sponsor is being elected on site for each event being monitored and consultation .

14. SELECTION OF VENDOR: The vendor selection process can be a very complicated if you don't know how to approach it from the very start. Here are six steps for the selection of the right vendor: Analyze the business requirements Contract negotiation mistakes Vendor search Request for proposal (RFP) & request for quotation(RFQ) Contract negotiation strategies Proposal evaluation and vendor selection Six steps

15. Vendor selection: Step 1: Define and Analyze Business Requirements What is the organization asking a third party to provide? A good start would be to assemble an evaluation team that is knowledgeable in the vendor selection process and has a clear understanding of what the business is all about. The evaluation team should be able to: Define the product, material or service that is needed; Define the Technical and Business Requirements; Define the Vendor Requirements (i.e. the features the organization is looking for in a vendor) Publish a Requirements Document.

16. Step 2: Identify Third Party Vendor Candidates After the evaluation team has published a requirements document it must now compile a list of possible vendors. The team should send each one a Request for Information (RFI) and conduct a team evaluation process. A short list of vendors is then created. Step 3: Develop Evaluation Criteria (with weighting) In this third step, the team would construct an evaluation model that weighs a requirement against its value and priority. Step 4: Conduct Vendor Briefings Once the team has developed evaluation criteria with weighting and further narrowed down possible vendor candidates, it’s time to set up an initial meeting with each potential vendor to discuss stated requirements and ensure a common understand.

17. Step 5: Evaluate Vendors and Schedule Demos After completion of vendor briefings, the team should be better equipped to evaluate potential vendors. Selected vendors should provide a solution overview to the organization’s current business and technological requirements, fees, benefits derived from using a particular vendor, etc. In addition, vendors are requested to provide a “demo” to showcase the capabilities of their solution. Demos are a valuable way to get more information and also evaluate intangible aspects of a vendor. It is critical to check the vendor’s references as a part of the evaluation process.

18. Step 6: Complete Vendor Selection Primary and Secondary Options At the conclusion of the evaluation process, the team will identify a primary option (the winner) and a secondary alternative. Step 7: Complete Contracting with Vendor This step includes identifying a clear set of objectives, deliverables, timeframes, and budgets for the project with the vendor. These should be clearly written in the terms of the contract. One of the most important factors in the vendor selection process is to develop a contract negotiation strategy. A successful contract negotiation simply means that both parties will search for positives that will benefit the two parties in every aspect while they achieve a fair and equitable deal .

19. Procedure for Qualification of Vendor for ‘Raw material and Packaging material’ in Pharmaceutical Industry: The new Vendor must be qualified and approved by QA department before regular supply of raw material in following manner given below: Purchased department will locate the new vendor and find out detail of manufacturing/ supplying of new product carried out by them. Purchase dept. will submit the sample to R&D or QA dept. for evaluation. Sample from 3 consecutive batch of active ingredient should be procured as preshipment sample along with crt . Of analysis.

20. Quality Assurance / R&D department should analyse the sample. After complete analysis of the sample, the analytical report along with comment from QA department shall be sent to purchase department. The vendor will be included in temporary approved vendor list if sample meeting all the specification. The purchase department after studying the comment of QA department shall inform the supplier for supply of material manufactured by them. An audit is performed by representative of purchase department and QA department. Purchased department shall carefully study the quality aspect and financial aspect of vendor.

21. Based on the product compliance and assessment further procurement of raw active material should be continued. All suppliers evaluated by R&D dept. on the basis of process development parameter shall be considered as temporary vendor and will be included in temporary vendor list. Based on commercial production supply they will be transferred to approved vendor list and shall be considered as permanent. Vendor approved by the product license holder or contract giver will be listed separately as approved for product license holder

22. Procedure for inclusion of vendor in approved vendor list : New vendor must be approved and qualified by QA department before regular supply of packaging material in following manner: Purchased dept. will locate the new vendor and find out detail of manufacturing/ supplying of new product carried out by them. For printed and primary packaging material vendor audit is performed by representative of purchase department and QA department. Sample of printed material packaging material if necessary will be submitted to QA dept. for evaluation .

23. The purchase department after studying the comment of QA department shall inform the supplier for supply of material manufactured by them. Purchased department shall carefully study the quality aspect and financial aspect of vendor. Based on the product compliance and assessment further procurement of raw active material should be continued. All suppliers evaluated by R&D dept. on the basis of process development parameter shall be considered as temporary vendor and will be included in temporary vendor list. Based on commercial production supply they will be transferred to approved vendor list and shall be considered as permanent.

24. Procedure for exclusion of vendor from approved vendor list: Vendor shall be disqualified and removed from approved vendors list for following reason: 1. If lot does not comply with specification with respect to critical test then vendor shall be disqualified. The vendor shall be qualified again for further evaluation and investigation. 2. If lot does not comply with specification with respect to minor test then vendor shall be disqualified if observed for 3 consecutive lots . 3. out of 10 lots fails to comply with specification in specified period under review. 4. The delivery schedule is not met for 40% supplies .

25. Corrective and preventive action: The vendor who has been excluded from approved vendor list may be included again by taking following CAPA: The vendor shall be made aware of reasons for his exclusion and shall be asked to explain. Head purchase and head QA & QC shall conduct facility audit of vendor in order to ensure that quality of system exist in organization. Carry out the discussion on other non-quality issues like delivery schedule and rate etc.

26. EVALUATION OF VENDOR: As a consumer, when you want to purchase an item, whether it is a raw material you will most likely do some research on the prices of your local stores or from vendors on the internet. When you have narrowed your search you then look at other criteria that may be important to you, like warranty or availability . Lastly you will look at other less tangible criteria such as your previous experiences with the vendor and how their customer service was. This behavior is exactly the same for companies when they want to evaluate the vendors in their supply chain.

27. Vendor certification: Objective: To ensure that the materials purchased are of consistent quality. To minimize the inspections of incoming goods( based on the supplier’s certificates) to a certain level. Vendor certification leads to reduction of costs and release times

28. RESPONSIBILITY: It is the responsibility of the quality assurance manager to develop the vendor approval system and maintain SOP compliance.

29. VENDOR CERTIFICATION PROCEDURE The vendor certification procedure may include: a list of selected vendors historical review of test results of previous suppliers Formal inspection on site decision making

30. Selection of Vendors to be Certified The selection of vendors to be certified should be jointly made by the heads of purchasing and production and the quality assurance manager. 2. Review of Historical Data and Test Results The quality data of batches delivered during the last 3 years is summarised and a trend analysis is prepared. Deviations with regard to normal failure levels, out-of specification situations, and corrective actions is reported. The quality control and quality assurance managers shall review the trend.

31. 3 . Site Audit: The quality assurance manager or the system in charge may perform an on-site audit. The audit should specifically: Determine the accuracy, precision, and reliability of test and inspection data of the vendor. Review the process reproducibility and the batch records for process variations. Perform general GMP compliance inspection. Review the potential for contamination and mix-ups thoroughly.

32. Ensure that vendors’ in-process controls include the use of statistical process control, critical product parameters that are significant and may affect the final product quality Ensure the absence of significant online problems. 4. Recommendations It is not essential to perform on-site inspections. 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.

33. 5. Decision on Certification: The data obtained as a result of these reviews and audits shall be reviewed by the QA manager and sent for approval to quality control, production, and purchasing. Final release must be authorized by quality control. 6. Steps after Certification: Reducing the number of tests and inspections of incoming goods as agreed in the certification report, e.g., one out of ten batches. For packaging materials certification, it is sufficient to review the results of three suppliers. If during this process of verification no discrepancies appear, the verification may be discontinued.

34. For incomplete certification, a provisional classification report shall be published by the QA manager for components. Materials to be used in production without complete testing must be supported with acceptable certificates of analysis by manufacturers. All deviations regarding purchased materials encountered by production must be reported to the quality assurance manager for referral to the manufacturer or supplier.

35. 7. Recertification: Recertification of an active and excipient manufacturer may be performed on request. Recertification can be requested by quality control and production. The certification is valid for a period determined by the QA manager. Certification of packaging materials is valid for 5 years.

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