pharmaphorum

NOVEMBER 16, 2022

Cases of drug-resistant TB (DR-TB) rose 3% in 2021 over the previous year, the first increase since record-keeping started in 2004, according to the WHO report, which called for countries to move quickly to restore access to essential services to treat the disease, as well as greater investment in new vaccines and therapeutics.

Compounding 98

Compounding Vaccines 98

European Pharmaceutical Review

JANUARY 29, 2024

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. 2004; 29: 100298. J Pharm Sci.

FDA 111

FDA Vaccines Compounding 111

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. EU human tissues and cells directive 2004/23/EC; 7. Viral antigen vaccines. Animal tissue.

Vaccines 97

Vaccines Compounding Documentation FDA 97

PharmaShots

FEBRUARY 20, 2023

Since time immemorial, plants have been widely used as a source of medicinal compounds. These guidelines are largely specified by the European Commission (EC) in Directive 2001/83/EC and Regulation (EC) No 726/2004. Different species of Solanaceae have capacities to produce heterologous proteins such as the E.

Vaccines 40

Vaccines Pharmaceutical Companies Pharmaceutical Companies Compounding 40

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. September 2004. www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. 6 US Food and Drug Administration. Burke, S., Hammond, and T.

Documentation 52

Documentation FDA Packaging Communication 52