Have you ever looked at a prescription drug or medical product and thought, “Is this safe? Is it going to work the way it should?” If you live in country with a stringent regulatory authority able to effectively regulate the quality and efficacy of medical products available to you, then these questions may never have crossed your mind. If your country’s regulatory mechanism is not as stringent, you may have considered these questions, but you don’t have many other choices available to you.
The question remains, how can you tell if a medical product is safe and effective?
Unfortunately, the answer is not simple or straightforward because often one cannot simply look at a product and decide if it is helpful or harmful. The quality of a medical product originates with the manufacturer and is dependent on the use of high-quality raw materials and adherence to current Good Manufacturing Practices (cGMPs) during production. Once the product has been made, its quality must be maintained during storage and transportation. Regulatory authorities are responsible for verifying the quality and safety of medical products in domestic markets. Unfortunately, in many low- and middle-income countries (LMICs), these organizations may not have the capacity to adequately assess and monitor the quality of medical products.
E-Quality Partners (E-QP), LLC provides technical consulting, training and other capacity building services to support organizations in their efforts to ensure the security of their supply chains and reduce the risk of procuring unsuitable products. We work with...
Privately held (profitable/not-for-profit) public health consulting companies working in health commodity supply chains to assess supplier compliance with the appropriate international standard, draft product specifications and standard operating procedures, and provide guidance on suitable waste disposal options for medical products.
Pharmaceutical and laboratory suppliers, procurement service agencies (PSAs), importers, wholesalers and distributers of health commodities to improve their adherence to the World Health Organization’s Model Quality Assurance System for Procurement Agents (MQAS)
Quality control testing laboratories to teach testing methods and support the development and maturation of their quality management systems.
National medicine regulatory authorities (NMRAs) with Maturity Levels 1 or 2, who seek to improve their compliance with the WHO Global Benchmarking Tool (GBT).