February 25-27, 2018
The Westin Pune Koregaon Park, Pune, India
Dealing with Organic Impurities for effective life cycle management of chemical products
Tuesday, February 27th, 1:55 PM–2:20 PM Parallel session: Integrated Drug Development: Chemistry, Manufacturing and Control (CMC)
Session IV: Manufacturing
Abstract: Pharmaceutical or chemical industry has been producing one of the purest and safe chemical compounds for a long time, however they are highly regulated to ensure this keeps happening. All these companies are hence working/dealing with Impurities (and degradents) as a routine. In the recent past with increased focus on CMC business; it has become a centerpiece to turn around all projects quickly.
The reality is that, this task is not as easy as it sounds; they are required to work on it in detail; and generate all the necessary information involving several analytical and biological experiments. Organisations, be it pharmaceuticals or chemical, are spending a lot of time in ensuring the purity of a compound, though the formation of impurities is an inevitable part in this process. Additionally, in the current R&D landscape, it is mandatory for organisations to maintain the information of the origination, control and fate of all the impurities associated with the process of manufacturing. There is a need to captures all of that in an organized fashion and share from a collaborative interface. This presentation will outline how by taking small steps and making intelligent decisions you can take a big leap in your efficiency of dealing with impurities. This narration is about how with a systematic and unified approach at R&Ds we can enable identifying, characterizing and evaluating Impurities (& degradents). We will be sharing how the new technology can help in creating an impurity or product life cycle management system which will generate enough scientific justification and help control the impurities.