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Inspecting factories and devices

“My department, Quality Assurance (QA), assesses both the individual products and the factories where they come from,” explains Johan. If the purchasing team has an interesting supplier in mind, QA investigates whether the products meet the requirements of the World Health Organization (WHO). “For the assessment of all the properties of a medication, there is a separate questionnaire with minimum criteria that a product must meet. What raw material does a medicine consist of? Does that raw material meet the standards? But also: how stable is a medicine at a certain temperature?”

‘A product may only be sold if it has obtained QA approval’

QA also determines whether a factory needs to be inspected. In some cases, QA does that itself. In addition, the MEG has contracted an expert in India, where many of the medicines are produced. “The local expert inspects new factories for us. He then writes a report, which we in turn assess. Only when we are sure that everything is in order is the factory approved. And once every three years we inspect again.” In addition, QA also has medicines tested by sampling in a laboratory in the Netherlands or in India.

As a responsible pharmacist, just like CEO Marcel Claessen, Johan is legally responsible for the quality of the medicines and medical devices that the MEG supplies. Medicines must comply with clear European guidelines, such as the Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP). Another important standard is ISO 9001, which sets requirements for the quality management system of a company. Furthermore, the Dutch Healthcare and Youth Inspectorate (IGJ) inspects the MEG every three years to see whether we still meet all the conditions for a pharmaceutical wholesale license.

Quality is crucial

How does quality assurance work in practice? Let’s take an antimalarial as an example. Supposing this product meets all requirements, the MEG will then purchase it. Until QA releases the drug, it is in quarantine and is blocked by computer technology. The warehouse employees take photos of the product, check all labels and check the temperature logger. “Temperature changes affect the quality of the antimalarial,” states Johan. “It’s a lot warmer in India than it is here. With such a logger we can make a printout of the temperatures that the product underwent during transport from India to our warehouse.”

Last year, the new software program NAVISION-ERP (Enterprise Resource Planning) went live. All products, customers and suppliers are approved in this system. If that does not happen, the system blocks it and a medicine or device cannot be sold.

If all specifications are right, the medicine is released and packaged for the customer. What if QA has doubts? Then the product is stored and re-evaluated after additional tests. The sales team often wants to move ahead faster with the products than QA. “Not until we have given approval can a product be sold. A competitive starting position and thus an advantageous price are also important, but quality is paramount.”

Quality is also thoroughly guaranteed in the MEG’s distribution center. Every product is stored under the best conditions. So the temperature in the warehouse is precisely between 15 and 25 degrees and in the refrigerator it is between 2 and 8 degrees.

Local sourcing

The MEG has been doing local sourcing for a number of years. Wherever possible, medicines are purchased and developed locally, so that the African countries eventually become self-sufficient. One of the countries being focused on is Nigeria, where a quarter of all Africans live. “A range of products is now being purchased and produced in Nigeria,” says Johan. “We screen the various factories and select a number of them. By that time, the local authority has already approved them, but we do extra checks and inspections. So that we know for certain that the quality is good.”

Products are also tested locally by sampling. Take antibiotics, for example, that HIV-positive patients have to take every day. “We are now rolling out this concept further in East Africa. I think we are ahead of our competitors in this.”

‘Our work is not just about the quality of boxes, but about the quality of human lives’

Emergency trip to Oman

The MEG also makes the difference with its strong focus on quality, Johan thinks. Of course, things sometimes go wrong, but the company solves that immediately. For example, recently, a recall campaign had to be set up urgently. A batch of cholera kits had already been sent off to the WHO storage warehouse in Oman when the supplier called. Something was wrong with a batch of IV catheters. “When something like that happens, you have to act quickly,” says Johan. “There were two options: retrieve everything and replace it here or get on the plane to do it there.”

Together with a colleague from the warehouse, Johan flew to Oman. They destacked 60 pallets of products, opened the kits, removed the faulty catheters and replaced them with new ones. They also adapted the stickers and labels. “Customers appreciate such remedial action,” Johan remarked. “That shows that we are proactive and take problems seriously. And that we work openly, honestly and transparently.” That also counts as quality assurance in the opinion of the Quality Assurance manager. “Not only making sure that products are of good quality, but also providing fast and friendly service. Quality is a duty for all of us.”

Laundry list of wishes

Despite some bumps along the road, Johan is satisfied with the performance of the MEG in recent years. “Customers sometimes have a broad laundry list of requirements, but we deal with all of them. Whether there is an Ebola outbreak in the Congo, or a project to reduce infant mortality in Ethiopia.” There is a good atmosphere prevailing in the company, says the experienced pharmacist. “If we successfully complete a major project, we celebrate it together.”

Those successes ensure that Johan is still in the right place at the MEG. Although he likes to think back to his years in Uganda and Ghana. “Africa grabs you or it doesn’t grab you. I was immediately sold. Sure, there is a lot of misery and it’s hard work. But everything you do as a care provider contributes something. Your help is tangible. In the end, our work here is not just about the quality of boxes. It’s about the quality of human lives.”

Questions? Please ask them

Medical Export Group