It is one thing to mandate the printing of serialized barcodes on pharmaceutical packaging, and quite another to properly print these barcodes on said packaging to meet compliance.
This the second and last part of the Serialization and Beyond webinar wrap-up. You can find the first part here.
There used to be a time when one could discern a fake cosmetic product from an authentic one by just examining the package. Certain external characteristics—or flaws—like a misspelled word or a flimsy material would give it away. Now, printing and imaging technology has evolved and become so inexpensive that counterfeiters can easily obtain it to create packaging that fools even the savviest consumer. Third-party sellers online like Amazon, Jet.com and other smaller e-retailers have made it...
Systech has been conducting educational webinars on important market issues for many years now. Much of this has centered on getting our customers the information they need to meet major pharmaceutical serialization requirement mandates in the United States (DSCSA) and the European Union (FMD). Now, with these mandates “live”, customers are looking at value beyond compliance in their serialization environments and investments.
The European Union Intellectual Property Office (EUIPO) has just released a comprehensive report on counterfeiting and Intellectual Property Rights (IPR) infringement in the European Union.
One of the often-forgotten facets of a pharmaceutical serialization project is the requirement to revalidate the packaging line and process during implementation. If companies need to purchase and implement new equipment to accommodate serialization, revalidation is expected. But, like many companies, if retrofitting of existing equipment takes place, validation may not be thought of early enough in the project. In either case, you may end up in a rush to write and execute several...
Last week, I received a notice from the manufacturer of my car that the front passenger side airbag of my make, model and year had an issue and recall notice. However, the replacement part would not be available until Spring. Until the part is replaced, nobody can sit in the front passenger seat due to the significant dangers if this airbag were to deploy. What an annoyance, but how great is it that the manufacturer found me to provide the information and warning?
The EU Falsified Medicines Directive (FMD) deadlines are now live. It is now time to reflect on this massive undertaking, and look at some “lessons learned”. We say this, because we are hearing grumblings in the field that serialization implementation projects are still ongoing. Additionally, the data integration requirements require live data connectivity to repositories like the EU Hub. Finally, when companies create new packaging lines, they will need to be equipped for...
GAMP, also known as Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.
By Steve Tallant, Director, Product Management and Marketing
Until recently, counterfeit health and beauty products could not be verified as the actual product, or authenticated, quickly and cost-effectively. Unfortunately, counterfeiters have been able to obtain printing and imaging technologies that mimic the real thing. Furthermore, Internet-based distribution outlets have proliferated, and it is difficult to tell an e-retailer that sells legitimate products from one selling counterfeits.