Pharmaceutical Technology

FEBRUARY 3, 2023

This is really what has been very challenging for upscaling viral vector production and what leads some companies that have in-licensed projects with a huge amount of viral vector to slightly panic about future production,” she says. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. link] [2] Tang Q, et al.

Genomics 244

Genomics Genome Medicine Gene Therapy 244

Pharmacy Checkers

DECEMBER 12, 2019

In fact, they have the exact same problems as we do in ensuring that the active pharmaceutical ingredients (APIs) used to make our drugs are of the highest quality and without contaminants. FMD requires that every single prescription drug dispensed in the EU must be verified for authenticity via a mandatory 2D barcode on the packaging.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

Cloudbyz

AUGUST 19, 2024

Facility Controls: Ensuring that manufacturing facilities are designed, maintained, and operated to prevent contamination, errors, and defects. Packaging Integrity: Validating that the device’s packaging maintains its integrity and sterility throughout the shelf life, even after exposure to sterilization processes.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

FDA Law Blog

DECEMBER 14, 2023

They observed that unregulated cannabis products have been found to contain fentanyl, high levels of heavy metals, contaminants, and even high delta-9 tetrahydrocannabinol (“THC”) concentrations. In other words, a prescription written by a DEA-registered, state-licensed practitioner.

Regulation 59

Regulation Production Drugs Contamination 59