To accomplish this, we examine the individual drug product
components and process steps for potential elemental impurity contributions and for any controls (e.
Other sources of potential leachables to be considered are drug product
storage, process and filling equipment such as tanks, filters, reactors and disposable systems.
Mahler: Given the expertise and experience of our Drug Product
Services team, we will be able to provide state-of-the-art services based on strong, industry-based strategies and regulatory experience.
The FDA s recent inspection of the Downing Labs facility revealed sterility failures in 19 lots of drug products
intended to be sterile, endotoxin failures in three lots of drug products
, and inadequate or no investigation of these failures.
Two recent inspections of the Unique Pharmaceuticals facility conducted by the FDA revealed insanitary conditions that result in a lack of sterility assurance of drug products
produced at that facility.
Our ability to manufacture drug products
in real time, and synchronize manufacturing activities with patient recruitment, is proving an effective way of reducing drug development costs and improving efficiency.
The proposed rule would modify the description of one drug product
on the list and add 25 drug products
to the list.
The acquisition expands AMRI's drug product
development and aseptic clinical manufacturing capabilities.
In fact, the FDA and the EMA are now placing increased scrutiny on potential extractables and leachables in drug product
container and closure systems.
The quality, safety and efficacy of a drug product
can be linked to the suitability of a container closure system (CCS), and recent regulatory expectations in the drug development process are for early knowledge of the CCS, to contribute to the process of building quality drug products