Sourcing Active Pharmaceutical Ingredients (APIs) requires attention to detail and careful consideration of a variety of factors. Here are some important things to take care of while sourcing APIs:
- Quality: Quality is the most important factor to consider when sourcing APIs. The quality of the API can have a direct impact on the safety and efficacy of the finished product. Ensure that the API meets the required quality standards, such as the current Good Manufacturing Practice (cGMP) regulations.
- Manufacturer’s reputation: Choose a manufacturer with a good reputation and track record of producing high-quality APIs. You can check their compliance with international quality standards and regulations, such as the US FDA, European Medicines Agency (EMA), or other national regulatory authorities.
- Documentation: Make sure that the manufacturer provides all the necessary documentation, such as a certificate of analysis (CoA), product specifications, and regulatory compliance certificates.
- Regulatory compliance: Ensure that the manufacturer follows all the applicable regulatory requirements, such as FDA’s Drug Master File (DMF) and Certificate of Suitability (COS) for APIs.
- Supply chain security: Ensure that the supply chain for the API is secure, and that the manufacturer and supplier have implemented proper measures to prevent contamination or adulteration of the product.
- Price: Compare prices from different manufacturers to ensure that you are getting a fair and competitive price.
- Stability: API’s stability is important to ensure the safety, efficacy and shelf life of the finished product. Check the expiration date, storage conditions and stability data of the API.
- Capacity: Evaluate the manufacturer’s capacity to ensure that they can meet your production needs and can handle any fluctuations in demand.
Overall, the sourcing of APIs requires careful consideration of quality, documentation, regulatory compliance, supply chain security, price, stability, and capacity. It is important to work with a reputable manufacturer who can provide high-quality APIs and reliable service.