Glossary
Clinical Manufacturing
What is Clinical Manufacturing?
Clinical Manufacturing or Clinical Trial Material Manufacturing (CTM) refers to pharmaceutical manufacturing for clinical research purposes. Clinical manufacturing requires acute attention and flexibility.
What are the guidelines for clinal manufacturing?
Businesses need to adhere with cGMP guidelines for proper clinical manufacturing thereby ensuring product stability by establishing manufacturing parameters, conducting quality control testing and maintaining detailed documentation for regulatory submissions.
What is the difference between clinical manufacturing and commercial manufacturing?
Clinical manufacturing happens for clinical research. Herein, the batches are considerably smaller than commercial manufacturing batches. During commercial manufacturing, parameters such as formulations, dosages, etc are fixed. In clinical manufacturing, the parameters are determined and accordingly if the product meets regulatory and quality standards, its commercial manufacturing begins.
