Vendor Evaluation Procedure in Pharmaceuticals qualification is the process of determining whether a vendor can provide the required goods or services to the standards that the purchasing company requires. This article describes in detail how to qualify raw material vendors, packaging vendors, and service providers. This also explains vendor evaluation and re-evaluation.

The vendor Evaluation Procedure in Pharmaceuticals assessment is a process that businesses can use to determine whether prospective vendors and suppliers will be able to meet their organizational standards and obligations once they are under contract. The ultimate goal is to secure a portfolio of low-risk, best-in-class vendors and suppliers.

PURPOSE:

1. It is intended to provide a system to qualify a vendor /supplier as per cGMP and local regulatory requirement.
2. To establish a system and instructions for evaluating, selecting and monitoring vendor performance to ensure their initial stability.

SCOPE:

1. This procedure applies for the purchasing of local and imported items in orderly manner.
2. To streamline the process of vendor identification and development.
3. To streamline the process of new vendor registration / approval.

RESPONSIBILITY:

1. Director QA is responsible for the control and maintenance of the vendor evaluation with assistance of evaluation committee including GM Production, Quality Control manager and Procurement Manager.

ABBREVIATIONS:

• SOP Standard Operating Procedure
• QA Quality Assurance
• D Documentation
• MP Mass Pharma
• QAF Quality Assurance Format
• Rev Revision
• N/A Not Applicable
• EDO Executive Director Operations
• GM General Manager
• ISO International Standards Organization

MATERIAL AND EQUIPMENT:

N/A

SAFETY MEASURES:

N/A

PROCEDURE:

Vendor Evaluation Committee:

For the purpose of vendor evaluation, EDO has constituted a vendor Evaluation Committee. Vendor Evaluation Procedure in Pharmaceuticals the meeting of the vendor evaluation committee will be held on Quarterly basis or as and when required in which vendors are evaluated on the basis of vendor evaluation form and checklist.

The vendor Evaluation Committee consists of the following members:

• Director Quality Assurance
• Quality Control Manager
• GM Production
• Procurement Manager
• GM Plant
• GM Finance

Note: If any of the members missing due to any reason either he will appoint his representative who must be a suitably qualified or will give participation via any direct communication channel.

The responsibilities of the vendor Evaluation Committee will include: To Evaluate vendor of the following items/services:

• Raw Materials (Active & Inactive)
• Packaging Materials
• Machinery & Equipment’s

Evaluation Criteria:

The vendor Evaluation Committee shall evaluate the vendor on the basis of the following criteria:

• Product / Services.
• Quality Management.
• Reputation & Credibility in market.
• Price.
• Technical Capability.
• Ability to fulfill the company requirements.
• Certifications and Documentations.

Vendor Evaluation Form:

1. For the purpose of evaluation of new vendors in Pharma Private Limited the company uses vendor Evaluation form consisting of general, technical, product and financial information of the vendor.
2. Procurement Manager Email the vendor evaluation form (for indentor) or (for manufacturer) to fulfill within specified time period.
3. After fulfilling the requirement by vendor (Indentor/Manufacturer) the committee will overview the reply and after due consideration will appoint internal or external inspection team.
4. In case of local manufacturer at least one member of inspection team must be qualified team member from the Parent Company (Pharma Pvt Limited).
5. The inspection team will fill the checklist (for indentor) or (for manufacturer) on the basis of inspection done and make a Evaluation report which will be submitted to committee.
6. The committee will decide the decision of approval or rejection or any further consideration and finally be authorized by Executive Director Operations (EDO).
7. The records of the vendor’s evaluation will be maintained by Documentation Department of Quality Assurance Department and also the copy of record distributed to Procurement Manager.

REFERENCE:

1. ISO 9001:2008 standards Purchasing
2. ISO 9001:2015 standards Performance of external Providers

ATTACHMENTS:

• List of Approved Vendors.
• Vendor Evaluation Form (Indentor)
• Vendor Evaluation Form (Manufacturer)
• Checklist (Indentor)
• Checklist (Manufacturer)
• Vendor Evaluation Report