Between January 2015 and May 2016 there was a total of 28 warning letters issued to pharmaceutical manufacturers. 21 of those letters were centered around issues involving data integrity. If data is mutilated and changed, it does not promise that a product is safe, data integrity is extremely important to follow. It is used to … Read more
Automated visual inspection has been created to perform as an alternative to manual visual inspection. This type of inspection is used to lower the cost and speed up the inspection process; pushing more drugs into the market. In USP <1790> it explains that any inspection other than manual inspection has to be “equivalent or better … Read more
The dye ingress test method is a routine test for container closures attached to parenteral drugs and large molecule drugs. Traditionally, this method uses ten test samples and three positive controls. During this testing, the test samples are place in a vacuum chamber and pressurized with dye. Three vials are punctured to allow dye to … Read more
In an article written by Louis Garguilo, Chief Editor for Outsourced Pharma, it talks about defining the term “essentially free” of visible particulate matter. In 2005, it has become a big concern with the number of injectable drug product batches being rejected or recalled because of particulate matter being present. In 2014, recalls in injectable … Read more