Non-Pharma Products Prequalification Guide for Suppliers

PFSCM prequalification of non-pharmaceutical products is coordinated through our Quality Assurance & Regulatory (QA&R) unit. This quality and regulatory assessment of non-pharmaceutical products – through a standardized procedure in compliance with the WHO model quality assurance system (MQAS) for procurement agencies – is aimed at determining whether a product meets our prequalification requirements and can be procured.

• The full prequalification assessment process includes the review of a full product dossier according to the quality and regulatory requirements defined for each product risk class.
• The duration of the validity of the prequalification status of a product is dependent on the manufacturer’s continuous fulfillment in meeting our quality and regulatory requirements.
• The findings are used to assess the regulatory and quality compliance of a product commercially available for procurement on behalf of our clients.

Please download PFSCM’s Non-Pharmaceutical Products Prequalification Guide for Suppliers here. Vendors are encouraged to familiarize themselves with the prequalification steps explained in this document.

Reporting product quality incidents

At PFSCM, we prioritize maintaining the highest standards of product quality by enforcing robust Quality Assurance policies. These policies cover all products which PFSCM procures, transports and delivers and are safe for use and maintain quality throughout their lifecycle, including during transportation and delivery.

PFSCM only sources products that meet stringent, globally recognized quality benchmarks. This includes compliance with the specific quality requirements outlined in various applicable QA policies.

To uphold these standards, we collaborate with a vast network of PFSCM-approved suppliers, all of whom meet critical quality requirements, including current Good Manufacturing Practices (cGMP), ISO 13485:2016 standards for medical devices, and Good Storage and Distribution Practices. These frameworks ensure that the products we procure are manufactured, stored, and distributed under the highest quality and regulatory requirements.

PFSCM takes any deviation from product quality standards seriously. We possess the necessary expertise, systematic approach, and documented procedures to thoroughly investigate and resolve any quality issues, including out-of-specification products.

Our team is dedicated to identifying the root cause of the issue, implementing corrective actions, and preventing recurrence to maintain the integrity of our product supply chain.

In the rare event of a product quality issue, our team is ready to assist in resolving the matter efficiently. Should you encounter a product that does not meet quality specifications, we encourage you to promptly log a Product Quality Incident using form #F-QA&R-005-001-12. You can report this by emailing productquality@pfscm.org. Our team will provide guidance and ensure a resolution is reached through the resolution process and also ensure the situation is addressed correctly and rectified swiftly.

Download the form here:  #F-QA&R-005-001-12

Quality Management System

We are certified to ISO 9001:2015 Quality Management System (QMS). We first received our ISO 9001:2015 certification in November 2014, and have been recertified every three years since then. The certifications were awarded by one of the world’s most reputable certification bodies for management systems, DQS Management Systems Solutions. Our QMS is compliant with the WHO-MQAS and our Woerden facility holds a Wholesale Distribution Authorization (WDA), we also are aligned with ISO 20400:2017 requirements for Sustainable Procurement.

Please send an email to sourcing@pfscm.org if you are interested in becoming a PFSCM supplier.