Presentation of a new supplier (manufacturer and supplier), preliminary assessment using a questionnaire, evaluation of samples before shipment, formal meeting of the buyer for technical coordination (optional), annual calendar of the vendor audit program, audit vendor quality system, production performance system, reports and monitoring and final approval/rejection. The procedure will be applicable to the starting material required for bulk pharmaceuticals, pharmaceuticals, and packaging materials

Quality Control Head:

Prepare a standard specification to test the necessary packaging materials and components, analyze the acquisition of samples and provide a certificate of authenticity to the head of the quality control department.

Purchase Incharge:

He who identifies potential manufacturers/suppliers and collects samples from suppliers/vendors for analysis according to the specifications provided by the quality assurance department.

Quality Assurance Head:

He who reviews the results of an acquisition sample submitted by the Purchase department and verifies the questionnaire completed by the seller, verifying that the internal controls and relevant analytical services are adequate to provide materials that must consistently meet the approved test specifications. Finally, approve or reject the vendor

• The current vendor must remain approved based on the results of its previous operations unless it is necessary to reassess it.
• In all cases, background information about the vendor (in this case, the actual manufacturer) and its quality systems must be obtained using the questionnaire, regardless of whether it is the current, new national or foreign supplier
• The questionnaires should be reviewed and updated periodically to gather information on quality systems, the general history and the organizational structure of the supplier
• Regardless of the degree of urgency, the need to receive a letter of consent and a duly completed questionnaire and your consideration will be emphasized before sending a trial order.
• The purchase department and the Quality Assurance department review a duly completed questionnaire received from all vendors.
• A technical staff meeting must be organized on both sides to assess their capabilities before visiting the vendors.
• Any other additional information or technical coordination that may be required from any address.
• Send the vendor selection questionnaires to all vendors as described above and receive a response within 15 business days and send them to the General Quality Directorate.

Preliminary Evaluation

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1.Subject to a critical assessment of the need for a new provider, the reference information (agreed upon) should be obtained through the questionnaire

2.A formal meeting of technical staff from both sides will be organized and held.

3.Subject to satisfactory negotiations and agreed terms, a copy of the Company's internal specifications will be issued to the seller to request samples before shipment.

Sample evaluation before shipment:

In accordance with the agreed specification and technical discussion, the supplier must organize the shipment of samples before sending (3 in the case of domestic suppliers and at least one for foreign suppliers) of independent lots to the procurement department along with their certificates of analysis that correspond to the specifications of the Company.

Samples before shipment are accepted only if they are accompanied by the following documents:

a) An official document duly signed by the manager in question.

b) Consent to the Company's specifications

c) Certificate of analysis that meets the Company's specifications.

d) a duly completed and completed application form.

Samples will not be accepted if they are not accompanied by the above documents.

1. After all specifications, analysis method, sampling requirements, etc. have been issued, all samples must have the Company specification before shipment/test order, and no replacement should be made. If the Procurement Department still wishes to receive samples of samples/shipment of the trial order.

2.After the quality control verification, the sample must be sent to the production department (optional) along with a duly completed form for the approval of the new supplier and the analysis certificates received from the supplier, and our internal test report.

3.The new supplier, recommended for production after passing satisfactory tests to launch a new product, takes into account the quality control quality analysis, and the remaining formalities remain unchanged.

4.The questionnaire, the consent for the specification and the quality of the sample must finally be evaluated by QA based on COA. In a specific situation, such as suitability through the evaluation or stability test, the approval of the seller is expected until it is completed, and the same will be reported to the Sales Department.

Based on the analysis of the questionnaire, the technical discussions, the analytical conclusions of the sample before shipment and the importance of the position, the quality control should indicate the need for an audit of the supplier's plant (if necessary). In the event that this is not necessary, the QA may also recommend the approval/rejection of the provider, as the case may be. The head of the interested procurement department/manager will arrange a visit to the plant as soon as possible, acceptable to both parties, but preferably within a week. The supplier's quality systems audit must be performed by a quality control representative, preferably accompanied by a sales representative during the audit visit. Production and quality control representatives should be invited, if necessary. The quality representative should guide the audit and briefly summarize the audit observations and conclusions for the organizational structure during the post-audit discussions. Quality control should provide reports on visits to the supplier and provide final comments on the general technical capabilities of the seller with the recommendation of approval or rejection of the "new seller". The approval must be related to a specific production site that has been evaluated; Subsequent changes will require additional "approval" from the Company. The procurement department must give its final comment on the commercial aspect and obtain the approval of the Technical Director. or as necessary. The technical director must approve or reject the supplier for a general evaluation of the "technical and commercial" aspects.

QA informs the interested company about the location/accumulation of production, purchase, and accumulation of stores about any addition of a new supplier or the elimination of a supplier through the addition.
At this point, the supplier is considered "APPROVED" for the product/product category.
The purchasing manager must now organize and initiate the acquisition of materials from these approved suppliers on a regular basis.

QA Department should contact the store department. Organize 3 batches of raw material samples to evaluate existing suppliers. These samples are transferred to the quality control department. For analysis according to the specification of raw materials.

QC Department analyzedthe sample and the results are presented in the QA Department to verify the quality of the data.

Based on the raw material test data, the head of the quality control department will decide on vendor approval/rejection and registration details

We have an enriched qualified team to Analyse and perform the Qualification of Vendor for the Pharmaceutical Organizations.
Our QA Team has vast experience in analyzing the sample,verify the quality of the data and produce accurate results.