Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.
A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.
While the entire pharmaceutical industry must be aware of combustible dust from API and excipient ingredients, the production of oral solid dosage (OSD) drugs is the most at risk.
The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.
Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.