InstantGMP™ is an electronic batch record system for GMP manufacturing. It is a cloud based applicaiton that can streamline the entire process of producing products that are regualted under Good Manufacturing Practices.
The quality system was initially developed by the manufacutring experts at PharmaDirections. They used a Quality by Design approach to create a software applcation that would incorporate the requiremets of the SOPs and GMPs into the processes governed by the system. This allows for improved compliance and quality. Since the applicaiton is delivered through the web, there are opportunties to improve process flows and productivity.
For more information, visit www.InstantGMP.com.
Oraleze™ is a drug delivery technology designed for pediatric and geriatric populations. It is a soft, palatable high capacity dosage form with unique texture and shape. It maximizes the dose that can be delivered while minimizing muscle movement needed for swallowing. Over 1 gm of small molecule drugs have been incorporated into a single dosage unit. The shape also allows it to be marked for multiple subdivisions so it can be easily tailored to provide mg/kg dosing in pediatric applications. It can also be structured to taste mask bitter drugs or to provide sustained delivery of large dose drugs.