ISPE

JULY 5, 2023

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. End-to-end continuous processes flow from starting materials to finished dosage forms.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

JULY 6, 2023

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed.

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52

ISPE

JULY 6, 2023

Advanced technologies such as CM have the potential to greatly transform pharmaceutical production processes by improving drug quality and supply continuity for consumers worldwide while benefiting the company’s bottom line. One of the most important components of SRM is the company’s risk appetite statement. NASA.gov, 2015.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

1 , 4 A Retrospective Journey In 2015, Vertex’s Orkambi was the first approved drug produced under a CM process for the treatment of cystic fibrosis. An average of two approved drugs via CM per year since 2015 shows that progress has been slow but steady and that interest in CM and its potential has been sustained.

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52