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ROI CalculatorVendor qualification consists of determining and approving external vendors who deliver products or services that impact the pharmacovigilance process. This includes both evaluating the vendor's abilities and also ensuring compliance with regulatory requirements and determining their appropriateness for the specific activities required.
Vendor qualification and vendor management is a necessary part of a successful drug safety program. Pharmaceutical companies utilize external vendors to assist with any number of activities, including adverse event reporting, processing data related to the safety of a drug, and to provide regulatory intelligence regarding safety. These external vendors can be split into traditional types of vendors, as well as non-traditional vendors that don't usually support businesses in the same manner (e.g., social media influencers or MROs), who may also receive and process safety-related data for the manufacturer. Hence, it is necessary that all vendors are meeting high quality, compliance, and data integrity standards to continue to provide a safe and effective medicinal product.
Needs Assessment: Identify any specific services and/or products that will be required of the vendor(s), which may include but are NOT limited to: Adverse Event Data Collection, Data Management and Market Research.
Vendor Identification: Identify potential vendors who could fulfill these functions, which may also include traditional service providers as well as non-traditional service providers.
Due Diligence: Conduct thorough evaluation of vendor qualifications (e.g., QMS, compliance history, and financial viability).
Risk Assessment: Assess all risk factors posed by the vendor’s business activities, especially consider potential for social media influencer type business entities because they are not as familiar with compliance standards as traditional vendors.
Qualification Audit: Use on-site or virtual audit to verify vendor’s compliance with good pharmacovigilance practices (GVP), data protection standards, and others. For some of these non-traditional vendors, the audit will primarily focus on how well they understand requirements and have capability to manage safety information appropriately. You can also utilize a detailed questionnaire instead of a “desktop audit” for low-risk vendors.
Approval and Contracting: If vendor meets all qualifications, establish formalized relationships with the vendor through an agreement that clearly defines scope, roles/responsibilities and compliance obligations. The agreement will also define the audit frequency/timeframes, data protection criteria, and reporting criteria.
Accomplishing a strong vendor qualification process entails planning, criteria, and steady assessment. Here are some of the key steps involved:
Define Requirements: Identify the key criteria that you need your vendors to meet, including: quality certifications, ethical compliance, financial viability and sustainability. Adjust your criteria based on business objectives.
Conduct Pre-Qualification: Assess potential vendors with a variety of preliminary assessments to decide if they can meet your basic requirements (such as capacity and regulatory compliance).
Assessment & Evaluation: Conduct further assessments of potential vendors with detailed on-site inspections and product samples to verify the vendors’ capabilities. Assess vendors for their operational strengths, financial performance and risk factors.
Approval & Documentation: Once you approve a vendor based on the criteria outlined above, that vendor will become part of your vendor database. Document any evaluation information as well as information regarding ongoing evaluation of vendor performance.
Monitor & Reevaluate: Qualifying vendors does not stop after they are approved to do business with you. It is important to continue to evaluate a vendor’s performance against criteria over time, adjust your criteria as needed as your business needs change.
