The client is a manufacturer of sterile pharmaceutical and biotechnology products. They have approached Freyr for gap analysis of their design control documents for drug combination products for successful compliance with the US FDA. Among the two (2) devices of the client, one had the design history file (DHF) which required gap analysis and remediation and the other device required compiling DHF.
Apart from identifying the gaps as per 21CFR Part 820, what were the other challenges that needed Freyr’s attention. Decode with this case study. Download.