Supply chain failure is considered a top threat to life science companies, second only to intellectual property theft. Despite the risks, the market for contract manufacturers continues to grow at a rapid pace. In fact, experts predict the global contract manufacturing market for pharmaceuticals will exceed $79 billion in 2019.
There are several reasons for this rapid growth:
• Contract manufacturing allows companies to increase capacity without the overhead of increasing their own staff and production capabilities. This lets companies move more drugs through the pipeline of FDA approvals faster.
• For some startups with almost no manufacturing capability, it is the only route to manufacturing their products.
• Suppliers and contract manufacturers can provide specialized expertise that helps expedite the drug development and manufacturing process.
To achieve these benefits while mitigating the risks, many companies turn to supplier quality agreements as a way to ensure compliance with internal and regulatory standards.
In this post, we’ll look at 7 must-haves for your supplier quality agreements:
1. Set Clear Expectations
2. Determine Third-Party Requirements
3. Consider Storage and Shipment
4. Determine Documentation Needed
5. Outline Conflict Resolution
6. Define All Terms
7. Include Expectations Around QMS Use.
