Tag Archives: data integrity

Visible Particulate Matter in Single-Use Bags

In an article published by BioProcess International, visible particulate matter in single-use systems (SUS) is stated to be a big concern.  SUS is a product/equipment designed to be used once; it is primarily composed of plastic that can be discarded easily.  It is necessary when creating products with SUS, the parenteral drugs must be “essentially…
Read more

Parenterals, Particulates, and Quality by Design

Particulate matter in parenteral drugs has been a known issue for over two centuries.  Particular matter could come from any little thing that is involved in the process of making the drug product.  Contaminants could come from the environment, packaging for the product, ingredients in the product, reactions of the formula and anything that could…
Read more

The Importance of Data Integrity

On January 15, 2021, GMP Trends posted Issue #1056.  In this issue, it states that the FDA found a Pharmaceutical manufacturer’s lab that was not recording data and other information properly for years.  For starters, the equipment calibration and logbook were not updated for 18 months, the possession of the drug products were not tracked…
Read more