The drug making process has increased in complexity driven from globalization, cost saving demands and a specialization of suppliers in only one or a few subparts of the process. The separation of key process steps such as Active Pharmaceutical Ingredient (API) creation, clinical trials or outsourced manufacturing into different locations has been a driving force to mandate better traceability of data and an overall improved quality for the drug making process.
Adherence to data integrity guidelines helps provide higher transparency and traceability across the distributed nature of the drug production process. But it does not end with data integrity – that is just a first (notably significant) step as part of a broader quality initiative, that thought-leaders from the regulatory agencies are demanding, which may end up in a transformation of the pharmaceutical industry. This is being referred to as “Pharma 4.0”.
