Jennifer Markarian

Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.

Optimize practices and meet requirements using electronic data integrity systems.  

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

Consider best practices for placing, maintaining, and calibrating temperature sensors.

A Q&A with PCI Pharma Services about best practices for choosing and maintaining temperature sensors in cold and cryogenic storage.

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.

The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.