Is It Ever Too Soon To Start Your Performance Testing Assessment? A Primer On The Roadmap For Developing An Injectable Combination Product
By Mike Ulman, Technology Manager, Packaging and Delivery Systems
In this comprehensive guide, discover the essential steps and processes involved in developing injectable combination products, from setting up a quality management system and design and development plan to conducting design verification testing and risk assessments. Learn about the importance of design controls, Critical Quality Attributes, and control strategy in ensuring product safety and effectiveness. Explore the necessary documentation and regulatory requirements, as well as statistical techniques for determining sample sizes in design verification.
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