In this conversation, Anne and Kim discuss the process of material qualification, covering topics such as the steps to take, considerations for new materials, challenges, and documentation requirements. They also touch on the importance of risk assessment and the impact of supplier qualification on material certification.
Takeaways
- Material qualification and supplier qualification are two separate processes that go hand in hand and require careful consideration.
- Risk assessment plays a crucial role in determining the steps to take when qualifying a new material or replacing an existing one.
- Documentation and change control are essential for proving that materials have been certified and qualified during an audit.
- Considerations for new materials include location of the vendor, material accessibility, certification standards, and developmental work.
- Challenges in material qualification can arise from the inability to obtain three lots for testing, differences in compendial materials, and the impact of regulatory changes.
