I’m currently working on a project implementing the software to comply with the new requirement for China markets to include E-code serialisation ( barcodes in every pharmaceutical product distributed in China). The reason for the regulation is to support reimbursements and to avoid counterfeiting… My doubt is: does this system falls under predicate rules therefore requires validation??? Is counterfeiting control critical to patient safety?
Is anyone else working on a similar project?
Bvalencia
Interesting question, I am not sure if it fails under a predicate rule but I would imagine it would have to be validated fully, as this is a very important aspect to the traceability of the product.
I think if it is a new requirement for the Chinese market then, this alone should be the driver to ensure its fully validated.
Would be interested to hear more opinions on this.
I would think that falls under a number of predicate rules - labeling and traceability jump to mind.
GMP aside, wouldn’t it make sense from a business perspective to validate the system? Consider the case where it was not robust and counterfeit product made it on the market and caused some harm. If the company cannot determine that the product was counterfeit, there could be some serious liability concerns.
Thank you very much for your input… I think you are right… From a business perspective is high risk…and the main objective is traceability.
I have just completed a very similar project, there was a lot of debate on the GMP/ non GMP status. Where it is at the moment -
Reinbursement ONLY can be considered non GMP if you get the customer to confirm that they are not using it for traceability - this is what we did, and it was very difficult to get the buy in from the customer.
Labelling, serialisation, etc is GMP - no question as it normally contains batch data etc.
If I was starting again I would just go for all GMP, its much easier in the long run. This is only our approach - It hasnt stood up to auditors yet.
FYI - we had to slice the project up into small chunks and got each piece Validated before moving onto the next. Trying to do it all in one go proved impossible. The most trouble we had was at the machine level, trying to corrolate the numbers to the product.
Hi Barrowd,
Good comments on balanced approach one can adopt for this. This is a new requirement and whole globe will be in purview very soon. So this was a really great discussion on the future coming topics for other folks. Also thanks-a-ton to Ask About Validation team for providing us this plateform to learn, share and Implement.
No problem siddhipharma
http://www.askaboutvalidation.com/forum/member.php?13185-siddhipharma
and thank you for your valuable contributions.
[quote=siddhipharma]Hi Barrowd,
Good comments on balanced approach one can adopt for this. This is a new requirement and whole globe will be in purview very soon. So this was a really great discussion on the future coming topics for other folks. Also thanks-a-ton to Ask About Validation team for providing us this plateform to learn, share and Implement.[/quote]