Supply Chain Management of APIs

1. Can you briefly describe the critical stages of the supply chain for APIs within your organization?

Within the last 5 years the supply chain for API´s has experienced various challenges from missing container spaces, disruptions in transportation channels to GDP requirements and cool chain transports. As a distributor in between customer and manufacturer, our job is to foresee upcoming supply constraints and provide solutions to manage these obstacles.

2. What are the primary considerations that impact your decision-making process when choosing suppliers for APIs?

There is always 4 main considerations to think of, while choosing new supply partners for our generic customers: 1) reliable quality 2) stable supply 3) technical and regulatory support 4) competitive pricing, these should be the main points to consider for any company within generics, when deciding for a new manufacturer.

3. How do you assess and manage risks associated with the supply chain of APIs, such as quality, regulatory, and geopolitical risks?

Besides working with a pool of already qualified and reliable suppliers, that have a proven track record in the manufacturing of API´s and their respective supply, bluefrog did establish a risk matrix, that considers any possible risk, such as geopolitical risk, to have a solution at any given moment.

4. What strategies do you employ to optimize inventory management and ensure a smooth flow of APIs through the supply chain?

At bluefrog pharma we implemented a working S&OP process, which includes communication to sales, logistics and customers. With our S&OP process we can assure to have a balanced liquidity and stock material that corresponds to customers demand.

5. Could you elaborate on your criteria for evaluating potential API suppliers? What role does quality assurance play in supplier selection?

Before choosing a new supplier for API´s one needs to understand 2 things first: 1) what is our customer’s requirement? 2) What is EU requirement? Knowing the answer to these questions, is the key for us to choose the right supply partner for us. If a known supplier fulfills these requirements, it is even better, as the trust level is already high.

6. How do you manage long-term relationships with API suppliers to ensure consistent quality and timely delivery?

bluefrog invests a big stake of its time in strategic supplier management. It is important, because only with a high level of trust and showing that you are a reliable and transparent partner, you can expect A-level service from your suppliers. You need to give in order to get.

7. What steps do you take to ensure compliance with regulatory standards and guidelines when working with API suppliers?

With new and existing strategic partners, we always suggest and support a     pre-on-site audit. It gives the need security to us as a distributor that regulatory compliance is give and for the API supplier it is a benefit to have an independent audit report at their availability.

8. How do you manage and mitigate potential supply chain disruptions arising from external factors like natural disasters or geopolitical challenges?

Our S&OP process gives us security to always have enough stock material to cater our customer’s needs. Additionally, we also consider the location of an API manufacturer´s production site, before choosing a new supplier.

9. What quality control measures do you have in place to ensure that APIs meet the required specifications and regulatory standards?

We have implemented an audited and working Quality Management System with defined processes and SOP´s that prevent us from ordering material that could be Out of Spec. However, there is always a very small risk that material characteristics have deviations compared to their specifications.

10. How do you handle deviations or non-conformances in the quality of received APIs? What is your process for supplier corrective action and preventive action (CAPA)?

Handling of deviations and how to manage CAPA´s is defined in our QMS. We follow up very closely and have a dedicated person for managing these 2 topics, to assure the proper handling.

11. Can you provide insights into your approach to maintaining regulatory compliance throughout the API supply chain, including Good Manufacturing Practices (GMP) and other relevant guidelines?

As a distributor we do not need to be qualified according to GMP, but this could change in the coming years. In that case we would feel ready, as we do have a strong and proven quality process. From our API suppliers we keep track of any existing GMP or CEP and monitor their expiration dates.

12. How do you incorporate technological advancements, such as blockchain, IoT, or data analytics, into your API supply chain management to enhance transparency and efficiency?

Yet, blockchain or IoT does not play a significant role in our supply chain, but we are aware that this might change in the coming years and it could be huge benefit for us as a company to improve supply chain processes.

13. Have you implemented any digital tools or platforms to monitor and track the movement of APIs along the supply chain? If so, what benefits have you observed?

We do not have implemented any live tracking system, as in most of the cases we have similar transportation routes and qualified forwarding agents. These forwarding agents however, can provide us with the needed live data.

14. In what ways do you use data analysis and forecasting to optimize inventory levels and reduce lead times in the API supply chain?

We use the data coming from our SAP ERP to optimize the order management process and foresee upcoming demands of customers. Analyzing and knowing your data is key to a successful supply chain.

15. What measures do you take to ensure ethical sourcing of APIs, considering aspects such as labor conditions and environmental impact?

An ethical approach towards manufacturing of API´s is one of our key principles. We strictly do not collaborate with suppliers that do not follow ethical approaches with regards to labor conditions or environmental topics.

16. How does your organization address sustainability within the API supply chain, including efforts to minimize waste and energy consumption?

We try very hard to optimize sustainability within our supply chain, by having it as a criteria while choosing new forwarding partners. Thus, the transportation industry itself needs to change much faster to see improvements.

17. Have you encountered challenges related to sustainable sourcing of APIs, and how have you overcome them?

Not yet experienced.

18. Could you share your perspective on emerging trends in API supply chain management? How do you anticipate these trends will impact your organization?

Controlled transports, product security and cool chain is a big challenge in the upcoming years. The cost for these ways of transporting is very high, but at the same time prices for essential medicine are not being increased in most countries. We as a distributor understood that we need to be transparent with regards to cost and offer customers various solutions to choose from.

19. What challenges do you foresee in the future of API supply chain management, and what strategies are you considering addressing these challenges?

Regulatory requirements for API´s are being increase year by year, but at the same time they do not correspond with manufacturer’s capability to cater these demands.

20. Is there any additional information you would like to share about your organization's approach to API supply chain management that hasn't been covered in the questions above?

We do think strategic and offer customized supply solutions to customers, depending on their individual needs and business model.