An active pharmaceutical ingredient (API) sourcing strategy is built upon a well-defined manufacturing process. The keys to the strategy involve using long-term suppliers early in the development process so that the control strategy for their manufactured material can be developed over time and ...
Many years ago I heard a QA executive say, “The only difference between
two batches of a validated process should be their dates of manufacture.”
The underlying message here is that the manufacturing process should
be so well designed, so well understood and so well described that it
is obvious ...
The demands for increasing control of drug substance physical properties
in the pharmaceutical industry have evolved considerably in the past
decade. Regulatory agencies must be assured that a continuous supply of
drug substance can be delivered to the patient, and that the drug substance
...
20th century English journalist Malcolm Muggeridge once said, “All new news
is old news happening to new people.” This quote seems oddly appropriate
when considering the recent interest in continuous processing within
the pharmaceutical industry. Continuous processing technologies have
...
How long can a pharmaceutical product be exposed to temperatures
outside the recommended storage conditions? How can product discard
be prevented in cases of temperature excursions? How to establish and
to manage the allowed time out of storage of a pharmaceutical product?
The short answer is: ...
Twenty years ago, the risk to drug substance/product quality due to
temperature excursions during shipping was not generally appreciated.
A series of studies led to several papers in USP PF which documented
some of the risks1-4. In response, increasing regulatory requirements
related to supply ...