By Joanna Gallant, Joanna Gallant Training Associates
In the event you've been living under a rock for the last several months, facility inspection information released by the FDA has thrust data integrity into the spotlight. As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control — assuming we will put the time into executing them.
By Sharon Nowak, Coperion K-Tron
The combination of twin-screw extruders, loss-in-weight feeding, and pneumatic refill systems is quickly becoming the manufacturing process of choice when developing pharmaceutical solid dosage forms.
By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based solely on reliance of vendor certifications, statements, and promises. To diminish such reliance new technologies have been implemented such as process analytical technologies (PAT), process controls, automation etc. Often, once again, these new technologies have been overexerted as the solution to all problems, activities that supposedly result in higher product quality due to better process controls.
By James Drinkwater, Bioquell Inc.
There is a need to improve efficiency in the pharmaceutical industry to meet the new challenges of globalization, competitiveness, and the increasing diversity of products.