In global healthcare, the assurance of the safety and efficacy of medicines and medical devices is paramount. Even the slightest defect can have severe consequences. For this reason, prequalification is a pivotal process capable of averting potential issues that may negatively impact patients or lead to financial and reputational harm for organizations.
With a strong commitment and focus on quality assurance and regulatory compliance, PFSCM boasts extensive experience in prequalification, ensuring that the health products sourced and procured meet international requirements. To date, PFSCM has successfully prequalified more than 5,000 products from more than 250 suppliers, showcasing our dedication to upholding stringent standards.
PFSCM’s process of product prequalification entails a comprehensive assessment of a product’s compliance through the scrutiny of quality, regulatory evidence, and product data. This includes working closely with suppliers to ensure the products meet the necessary standards.
Advantages of prequalification in health supply chains
- Reduction of potential risks associated with substandard or counterfeit products.
- Assurance of product effectiveness and reliability.
- Enhanced trust and confidence in the healthcare system.
- Minimization of adverse effects and treatment failures.
- Improved overall health outcomes for patients.
Dr. Maite Barthel, PFSCM’s Quality Assurance & Regulatory Responsible Pharmacist and Responsible Person, underscores the criticality of selecting and assessing quality and regulatory compliance within the health supply chain.
“Supply chain stakeholders all need to be accountable for maintaining the integrity of health products in the supply chain, and they also need to collaborate to ensure poor-quality products do not enter the supply chain at vulnerable intersections such as raw material supplies, manufacturing, distribution, and point of sale.”
Further, she emphasizes the necessity of internationally recognized product classifications and registered products from reputable regulatory authorities to uphold product quality.
“A move towards the harmonization of global product classification holds the potential to establish a uniform definition of risk and its severity worldwide. This would enable stakeholders to implement standardized measures based on a consistent risk assessment, thereby facilitating streamlined and expedited access to products on a global scale.”
While progress has been made, challenges persist in the supply chain concerning the provision of safe and efficient health products. According to WHO, an estimated 1 in 10 medical products in low—and middle-income countries is substandard or falsified. These substandard and falsified medical products can contribute to antimicrobial resistance and drug-resistant infections, a major imminent threat to the well-being of people around the world.
By prioritizing quality assurance and regulatory compliance, PFSCM has helped to prevent subpar health products from entering the supply chain.
Dr. Maite Barthel concludes that his proactive approach not only aligns with the organization’s objectives of improving access to affordable quality health products but also demonstrates PFSCM’s capability to address global health challenges on a large scale.