Each organisation is responsible for ensuring their vendors provide consistent quality of services and materials which are fit for purpose throughout the product lifecycle from production development right through to commercial distribution. Vendor management is the process of working with vendors, controlling costs and increasing value whilst ensuring quality and managing mitigating risks.

Upon identifying a shortlist of potential primary or alternative vendors based on their market reputation and cost, it is essential to evaluate the quality system of these vendors. This evaluation is crucial in determining whether the vendors have sufficient control over their operational processes. By conducting a comprehensive evaluation, we can gain a deeper understanding of the vendor’s performance and competency, which in turn highlights areas that may require improvement. The extent of this evaluation should align with the level of risk associated with the vendor. At Pharmalex, we are prepared to collaborate with organizations in developing customized vendor assessments that accurately reflect these risk profiles. Initiating this assessment early in the vendor selection process is of utmost importance and its integration into the overall risk assessment for the final product is vital. For vendors classified as non-critical or low-risk, the quality assessment may focus on specific sections of the vendor questionnaire or the submission of an ISO 9001 or equivalent certificate. On the other hand, high-risk vendors, particularly those providing critical materials or services, require on-site audits. These audits are tailored to the nature of the vendor’s services and their existing quality management system, adhering to standards such as GMP, GLP, GCP, or GDP. Importantly, when auditing finished products, we consider future potential markets to ensure alignment with diverse regulatory requirements within each jurisdiction. With our team of experienced auditors, Pharmalex is well-equipped to execute audits according to the relevant standards demanded by organizations, producing comprehensive and customized audit reports that provide all pertinent information. These reports facilitate the declaration of GMP compliance for API vendors. Lastly, it is crucial to perform a risk assessment to evaluate the potential impact of a vendor on the quality management system.

• Sustaining Risk Assessment in Vendor Management: As previously stated, including risk assessments into everyday operations and quality management systems is critical for long-term vendor management. Risk assessment profiles are reviewed on a regular basis and are updated in real time to ensure continual risk mitigation. The risk assessment process should be viewed as a supplement to regular audits, adding an extra degree of confidence.

Crucial to effective vendor management is the development of contractual Quality and Technical Agreements. Risk management should be integrated as a comprehensive control strategy within Quality and Technical Agreements between parties. These agreements function as a delineation of responsibilities, expectations, and quality processes, guaranteeing the consistent supply of products and services that meet established standards. In close adherence to section 7.14 of the EU-GMP guideline, Chapter 7 “Outsourced Activities”, PharmaLex collaborates with vendors to draft agreements that clearly outline roles and communication processes for outsourced activities. This proactive approach ensures that vendor comprehension of organizational expectations is precise, with exact details encompassing requirements such as Key Performance Indicators (KPIs). This, in turn, ensures an unwavering alignment of performance with expectations, continuous risk control and the seamless supply of quality products or services.