Abstract
Until recently, Tracy Moore worked with the Medicines and Healthcare products Regulatory Agency (MHRA) as an Expert Good Manufacturing Practice (GMP) Inspector, specializing in sterile products and data integrity. In the following article and interview, she draws on this experience to highlight:Regulatory considerations and requirements for GMP compliance when manufacturing advanced therapy medicinal products (ATMPs) How to identify specific gaps in compliance that may occurCommon areas of weakness found upon inspectionThe potential benefits and pitfalls of open versus closed processes
Full Text 
Sign-in/Register to access full text options
Sign-in/Register to access full text options 
Published version (
Free)
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
