A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.
Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.
Combination products represent a remarkable opportunity as one of the most dynamic segments in the life sciences and are projected to grow to $115 billion by 2019.
This article explores what is important when establishing an effective relationship with a CSP as the program moves from product and process design to commercial manufacturing.
FDA’s new guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements specifically addresses seven elements that should be included in a quality agreement: quality unit activities, facilities and equipment, materials management, product-specific considerations, laboratory controls, documentation, and change control.
In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.
When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk to the decision or process. This guidance laid the foundation for two important concepts that influence how we develop and guarantee the quality of our drug products today.