The US FDA set out its support for properly planned continuous manufacturing during a fascinating opening presentation at the first day of Interphex 2011 in New York, US yesterday.
Agency compliance officer Francis Godwin spoke on the subject and stressed that, for a drug industry focused on reducing costs and getting safe products to market as quickly as possible, continuous manufacturing offers significant advantages.
Godwin highlighted several aspects of the approach as beneficial for manufacturers – explaining, for example, that from a process development standpoint continuous manufacturing requires less material for experimental runs than batch production.
He also said that, increasingly, the Food and Drug Administration (FDA) is seeing pharmaceutical manufacturers link systems together to reduce the amount of time products are dormant on the factory floor and hence improve production efficiency and reduce timelines.
Preparation is key
But, while generally supportive of continuous drug production, Godwin cautioned that preparation and planning is the key to making the approach work, colourfully warning that: “If you don’t do your homework beforehand, everything blows up.”
He went on to explain that this must encompass everything process validation and controls under 21CFR 211.100 (a) to sampling and statistical modelling under 21CFR 211.110(b) and 21CFR 211.165 (d).
However, while Godwin said that this can be a challenge he asserted that appropriate use of PAT can go a long way towards helping drugmakers address these and other issues, highlighting its role in defect detection, fouling and determining appropriate cleaning requirements.
A Continuous batch?
Godwin also spoke about the tricky issue of determining what is a ‘batch’ within a continuous manufacturing run, which is a requirement of current good manufacturing practice (cGMP) guidelines .
He explained that while companies that use continuous manufacturing have a variety of ways of defining what a batch is, ranging from shift changes to volumes produced, the best approach is to consider a batch as the period of time over which a uniform product is made.
IPT at Interphex
The in-Pharmatechnologist.com team is at Interphex and will be covering all the breaking news, new technologies and deals from the show floor.