Conference in the IL3 (University of Barcelona)
20th - October - 2015
A process is considered adequately known when:
- All critical sources of variability are identified and explained.
- The variability is managed from the process
- The quality of the product and its attributes can be predicted correctly in the design space established by the materials, the environment and other conditions involved in its manufacture.
Focus production in the knowledge of the processes involved reverts to a drastic reduction of the costs and burden of validation systems, since different options are provided to justify and qualify the different production processes.
Big data and regulated industry: the new paradigm
- Cloud environment can not be compared with traditional systems
- Security access is managed in a different way
- The owner of applications become the end user
- Pricing is by use and service, not by licensing
- The validation concept should evolve to the new reality (GAMP X?)
- The science of processes is not based just in pre-defined parameters (CPP & CQA). All inputs and data can participate.
Nowadays, big data is accepted by Pharma R+D when computing power is required.
