GMP trends published “Are you protecting your lab data from deletion or alteration?” In this newsletter it explains a 483 that a manufacturing lab was caught altering data information. This lab manufacturer did not have a protected system for their data, meaning information is not locked down after being inputted. Information can be altered or…
Read more
Parenteral Packaging
Small volume parenteral packaging includes packaging sizes from 2 to 5 mL range and is most commonly included with local anesthetics, vaccines and other traditional injectables for patients. Small volume parenterals are used with a luer lock or luer slip that can directly connect to syringes. 10 to 100 mL containers are typically used for…
Read more
Novavax’s COVID-19 Vaccine
Novavax created the fourth COVID-19 vaccine that could be available in the US this year. This vaccine is reported to be a two-dose regimen and is highly effective out of all other US vaccines during the clinical trial. Novavax is seeking FDA approval and authorization while in the third quarter of their testing. Novavax is…
Read more
Routes of Drug Administration
The route of drug administration is defined as the path by which a drug is taken into the body. Drugs are administered varied by diagnosis, prevention, cure or treatment needed of diseases and other medical disorders. A drug must come in contact with the tissues of organs to achieve its desired effects. The route of…
Read more