pharmaphorum

APRIL 8, 2021

COVID-19 has been a trial-by-fire showing just how quickly drugs and vaccines can be developed under the right circumstances – but there is much to do to ensure this progress is not lost, said speakers at WIRED Health 2021, including the CEOs of BioNTech and BenevolentAI. . About the author.

Vaccines 93

Vaccines Documentation Communication 93

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Complete Data Gathering. Outline Guiding and Segregation Principles.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

AUGUST 30, 2022

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Additional requirements are described in ICH Q7.

Documentation 52

Documentation FDA Packaging Communication 52