ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Common Technical Document [CTD] sections).

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 11, 2023

Pharmaceutical Processing World. 1 May 2015. Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” Journal of Biotechnology 213 (2015):120–30. Rockville, MD: US Pharmacopeial Convention, 2015. Quality Considerations for Aseptic Processing.” 12 April 2016.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). October 2015. 7 An integrative (vs. Accessed 3 December 2022. www.ceguide.org/ 2 United Nations. Department of Economic and Social Affairs: Sustainable Development. link] 3 Peasoup. 7 November 2022.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52