The Challenge: Pressure from Authorities
Yes, we need to talk about Compliance! In the end, all core business processes in pharmaceuticals, be it procurement, manufacturing, sales or services are impacted by legislation and regulations. In this particular case, compliance even is the main driver behind probably all track & trace projects that are currently being executed in the industry. And even though some companies are already looking beyond pure compliance, trying to figure out how to derive additional value (and I will cover this in Part 3 of this blog-trilogy), the primary goal is to become compliant with the various track & trace regulations.
It Won’t Stop: Ever-Changing Global Track and Trace Requirements
As mentioned in a previous blog, the legislation to be applied is the one in force in the product’s target market. This means, the target market where a product ends up, determines which regulation actually takes effect; the only exception to this basic rule is India which established legislation for the export of drugs. So it is extremely important to get a good sense of the world wide legislation and to keep eyes and ears open for new emerging ones. So far, Turkey, China, Korea, India and Argentina have active legislation with Brazil being next in Dec. 2015 and the two largest markets following in 2017 (US) and 2018 (EU), respectively. Also look out for news from Saudi, Jordan, Russia and some more… but ultimately it’s a moot point to list them all as they change so quickly. So make sure to connect to your local sales subsidiaries who are dealing with the local legislators anyhow, reach out to service providers in this space or SAP as a matter of fact to get the current details. At SAP, we have established a serialization round table where more than 40 pharma companies meet regularly to exchange news on current and upcoming legislation as well as serialization project details and roadmaps.
Becoming and Staying Compliant: Key Considerations and Recommendations
All legislation includes a change on the product packaging, at a minimum the application of the serial number. In some markets, like the European Union, additional safety features are required by law, for example to prevent the replacement of the content of a valid package. These changes to the art work of the sales package have to be executed along very elaborated processes within the company and will require approval or reporting to the various authorities. This takes time and processes should be started way in advance.
Also, as serialization, i.e. the application of a unique identification on the product package, is a product attribute required by law, all related processes will become subject of validation in a GxP-sense, e.g. following GAMP standards. So basically all the requirements which are well known in GxP-scenarios like for example Part 11 rules for security, and electronic records, apply (check out the SAP Global ERES Regulations Whitepaper for details). This implies a solid validation plan to be in place for the entire “computerized process” including a potential vendor audit.
The validation of the computerized process will also include a re-validation of the packaging line. In most case, the packaging line will undergo significant reconfiguration changes as additional components like printers and scanners are added. The validation must also include the software connected to printers and scanners and their interface to e.g. SAP solutions for track and trace.
In a nutshell:
- Build a network with your peers and suppliers to align on national legislation as well as best practices
- Prepare for an end-to-end validation of the packaging process including any computer system
- Ensure during the vendor selection process that all your software can actually be validated.
To always stay on top of latest developments and best practices on track and trace in Life Sciences, watch out for the next blog! Please also feel free to approach us and to follow us on @SAP_Healthcare. We very much look forward to hearing from you, soon!