There has been an increase in seminars, news articles and general comment on joint FDA and EMEA (European Medicines Agency) inspections recently. It seems a day doesn’t go by that a guide or webinar invitation doesn’t pop up in my email. Is it all as scary as it seems? And how does it affect labeling systems?
With more products being distributed on a global scale and manufactured in several locations around the world many of our customers are concerned with being globally compliant not just US and EU compliant. But the advice we give in both situations is the same. Our advice has always been to adhere to the FDA standards as the ultimate standard when reviewing labeling systems that serve multiple geographic markets
Labeling software that is purpose designed for FDA 21 CFR Part 11 compliance and developed along GMP guidelines will ensure that a robust and compliant solution requiring minimal customization is implemented. It is all too easy to become embroiled in a long and expensive process to shore up existing infrastructure as new markets are entered or legislation changes. On occassion we have been called in where a project to adapt general labeling software to suit this highly regulated industry has gone horribly wrong.
Advancements in labeling technology offer global labeling managers even greater control and efficiency. For example web-based labeling systems allow individuals involved in the design, approval and production of a label to collaborate in a secure and compliant environment giving the global labeling manager complete control and visibility. Not only that, but print only access can be given to third parties such as distributors or contract packagers ensuring that only the correct label and variable data can be used and all labeling activity is captured in the audit log no matter where in the world it takes place.
Joint inspections? Bring it on! See PRISYM ID’s Medica solution for more detail on global labeling solutions.
