Beijing Novartis Pharma's Jinsong Feng on Quality Assurance in the Cold Chain

In this interview Jinsong Feng, PO-Head of QA /QC (Associate Director) at Beijing Novartis Pharma Co.,Ltd., speaks to Andrea Charles from Cold Chain IQ, about quality management in the cold chain and what steps Novartis is taking to prevent temperature excursions.

Cold Chain IQ: Would you please explain your current role and responsibilities? J Feng: I’m the site QA head, has the overall responsibilities in both Quality Assurance and Quality Control functions. I also have the oversight in QA aspect for our sales including distribution and transportation currently. That’s why I am interested in handling the issues related to supply chain. Cold chain supply can be very challenge because a lot of issues may raise during product transportation and distribution.

Cold Chain IQ: What does the term cold chain mean to you, and what is the most recognised definition?

J Feng: From my perspective, it means the transportation condition with temperature control at 2°C to 8°C. It is used for the temperature-sensitive products. However, when I research in the internet, it shows a lot different definitions, wider or broader than 2°C to 8°C. Some people think that less than 25°C is "cold chain". This means to me that the concept is not clearly defined and understand yet. [inlinead] Cold Chain IQ: People used to use the term cold chain for the 2°C to 8°C range, but in recent years, we have witnessed an increased focus on the ambient and controlled room temperatures as well. In addition there is more emphasis on temperature controlled distribution as a whole among stakeholders. How important is to ensure the quality of the temperature-controlled pharmaceutical supply chain?

J Feng: I believe that maintaining the product quality through the whole supply chain is very important since this process can really impact the patient safety and the efficacy of the product. As a QA responsible person, it’s very important to be sure there is no temperature excursion happened during the supply chain, and there is a system established to handle the deviation when it happens.

Cold Chain IQ: In your opinion, what are the top three risks to the temperature-controlled pharmaceutical supply chain in China?

J Feng: I think for the Chinese industry in this area, the awareness or the sensitivity is not really built both in manufacturer and the transportation service provider, this is the biggest risk.

And the second thing, in certain distribution steps, we can’t really control the impact of the environment, such as during custom clearance, or meet the extreme ambience condition, etc. The products may be treated wrongly.

Cold Chain IQ: Do you also think that the size of China is also an issue, and the variations in temperature?

J Feng: Yes, I think this is can be a challenge. China is huge, a better way is to use air-conditioned carrier to distribute the temperature control products, but that means additional cost. Typically, when the quantity is very small, from the cost point of view, a lot of company decided to take the risk in China. Cold Chain IQ: Why is C orrective Action and Preventive Action (CAPA) so important? J Feng: If you cannot really apply the proactive action and the preventive action, that there is a high risk of recurrence, in the worst case scenario it can lead to patient safety issue, as a pharmaceutical manufacturer, patient oriented thinking should be the priority

Cold Chain IQ: What steps is Novartis taking, what risk management strategies are you employing to prevent temperature excursions?

J Feng: Actually, for us, firstly we have a lot of stability studies to evaluate the risks, secondly, we use the cold box and air conditioned carrier to avoid the temperature excursion, monitor the transportation with the temperature data logger, etc., we are working on continuous improvement, that is why I am interestedin joining you to get more knowledge and best practices from peers. Novartis really take the initiative in this area with a real focus on the patient safety.

Cold Chain IQ: What are your thoughts on future cold chain infrastructure development?

J Feng: I know a lot of very professional studies is ongoing, for example, use the special designed cold boxes to maintain the temperature, map the transportation route, monitor the temperature excursion during distribution … even the GPS are applied for monitor the goods distribution overall process... all mentioned technology had applied in EU and USA, I hope they will be popular in China in the near future.

Cold Chain IQ: Cold Chain Logistics and the life sciences in 2013, what trends do you expect to see?

J Feng: In my opinion, I think this will be the fast-developing area. I witness the increasing attention/ concern for Cold Chain Management of Pharmaceutical products from recent HA inspection, I believe the Health Authorities (including China) will set a high standard for us. We must take some actions now.

Cold Chain IQ: What are you most looking forward to about the 4th Annual Biopharmaceutical Cold Chain China event ?

J Feng: I would like to join the discussion and get the practice-sharing from others and build up the network. Although some companies are competitors, if we work together we can really let the patient get the benefit. Novartis advocate quality beyond compliance, this is something, not only fulfill the requirement of compliance, from the patient-oriented thinking, we deemed to delivery best insurance to our patient.

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Beijing Novartis Pharma's Jinsong Feng on Quality Assurance in the Cold Chain

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