The publication of the new EU Good Distribution Practices (GDP) Guidelines in March 2013 has urged many companies in the pharmaceutical and biotech supply chain to invest in systems and procedures to become and remain compliant with the new GDP as soon as possible.
While most large pharmaceutical and biotechnological companies have their own in-house teams to interpret, implement and follow up on the new GDP guidelines, many smaller companies are still working towards their GDP certification.
Cogezaf is one of these companies. We spoke with Cogezaf’s Managing Director Pascal Bruyr, Quality Officer Marie France Dhondt and GDP expert Lieven Van Landuyt (Pauwels Consulting) to learn how they plan to make and keep Cogezaf compliant with the EU GDP guidelines. “The demand for reliable supplies is high.”
Certainly! Cogezaf is a wholesaler of pharmaceuticals. We are located in Gembloux between Brussels and Namur. We export pharmaceuticals to the African continent, in particular to Congo.
Years ago, our Managing Director worked as a volunteer in Congo. He fell in love with the country and he saw huge potential in exporting pharmaceuticals to the country. That’s how Cogezaf was born.
Why is there such a huge potential in Congo?
There are a lot of foreigners in Congo. Many of them work in the mining industry. These people have to take care of their own healthcare and medicines, so the demand for pharmaceutical products and reliable supplies is high.
What does your supply chain look like?
We get our demands from Congo. We get all the products here in Gembloux and we ship them to Matadi, the main port of Congo. From that point onwards, Getraco, our main partner in Congo, takes care of the goods. Getraco takes the goods from Matadi to Kinshasa. In Kinshasa there’s a large market place for pharmaceutical products. That’s where our clients buy our products.
Which organizations are you selling to?
We are selling pharmaceuticals to hospitals, pharmacies and local distributors. At the moment, we have the largest market share in Congo. We work hard to keep this position and to further expand our business.
Where exactly do you want to expand your business?
At the moment, we do most of our work in Kinshasa, but we plan on expanding our business to the east and to the south. We are particularly focusing on expanding our business to the province of Katanga and its capital, Lubumbashi.
“A GDP certification will be a unique selling proposition in its own right.”
We try to maintain our leading position through a mix of focused business development and long-term investments. For example, we currently focus on getting Cogezaf fully compliant with the EU Good Distribution Practices from March 2013.
How will a GDP Certification help you consolidate your position?
A GDP Certification will help us in 2 ways. A few months ago, we were contacted by a large pharmaceutical company to ship their products to Congo. In order to land this partnership though, we need to be fully compliant with the new EU GDP guidelines. An additional benefit of a GDP certification is that most of our competitors in Congo are not yet compliant with the GDP guidelines.
How far are you from getting the GDP certificate?
An external audit a few months ago showed that we still had some work to do. That’s why we decided to invite an external party to help us with the certification. That’s why we turned to Pauwels Consulting. “We got the GDP expert up and running in no time.”
We found you through your website. We liked the clarity of your website, the professional presentation of your company and the fact that you have an office in Switzerland, the country where one of our largest pharmaceutical partners resides. And, we were also looking for a multidisciplinary team that can help us now and in the future. Woking with an external partner is an investment for sure, but we expect a good return on investment.
How much time did it take to find a GDP expert?
That must have been one month at most, mostly because I was traveling a lot at the time. We got a quick response to our initial request and we got Lieven up and running in no time. “The procedures were not yet organized in a ‘living system’.”
Which brings us to you Lieven. Lieven, can you briefly describe your project here at Cogezaf? Sure. When I came here Cogezaf had just had an external GDP audit. That audit had shown that Cogezaf had a GDP license and a couple of procedures, but these procedures were not yet organized in a ‘living system’. Cogezaf needed to invest in its quality system and the documentation of its validation and qualification procedures.
And that’s what you helped them with?
Exactly. When I came in I first analyzed the results of the audit. I saw 2 main priorities: 1) the quality system had to be rewritten to a clear plan with actions and priorities and 2) all validation and qualification procedures of systems had to be fully documented. There were plenty of procedures available, but only few of them were actually written out on paper.
My first priority was to convince all stakeholders of the importance of GDP compliance. That wasn’t too difficult: Cogezaf was determined to get the GDP certification from day 1. Then, I updated the documentation of the quality system, and the documentation of the most important systems and processes. At the same time, I trained Marie France to look after the company’s compliance with the GDP guidelines.
“GDP compliance is an on-going process.”
Staying compliant with the EU GDP guidelines is an on-going process. We have now covered the basics. The action points from the audit have been taken care of and our progress has been reported to the company that ordered the audit.
Our next priority will be to keep the system ‘alive’ and to further complete and document the qualifications and validations of our infrastructure, materials, processes and transports.
Were you able to accomplish all your initial goals for the project?
I think we have covered 90% of the project goals. There will always be room for improvement, but we needed a pragmatic approach. We had to set our priorities within the boundaries of the EU GDP guidelines and Cogezaf’s business. We’ve certainly covered the basics. Now it’s up to Cogezaf to further complete all the documentation and to look after the implementation of all the procedures. “We consider our relation with Pauwels Consulting as a successful partnership.”
Marie France, the project has now ended. What was your general experience with Pauwels Consulting?
We are very happy overall. The quality and the speed of the work were very good. We consider our relation with Pauwels Consulting as a successful partnership. It’s a win-win situation. We were happy to pay for the excellent service we received. Working with Pauwels Consulting was a very pleasant experience overall.
Would you consider working with Pauwels Consulting again in the future?
Yes we would. We seriously consider hiring experts from Pauwels Consulting again. In particular, for future GDP audits. A little self-inspection has never hurt anyone (laughs).