Compliance In The Supply Chain: 3 Best Practices To Manage Regulations Around The Globe
By Trisha Gladd, Editor, Life Science Connect
As if it isn’t challenging enough to maintain compliance with the regulation agency of the country you’re located in, anyone doing business in pharma also has to maintain compliance with any other countries for which they want to do business. Meeting the regulations of every point along the supply chain is necessary for both the manufacturer as well as the logistics provider who is transporting the product, but what is the best way to achieve this? Mike Meakin, vice president of global quality and regulatory compliance at DHL Supply Chain, offers three best practices on how to manage the high volume of legislation and regulation encountered in a global pharmaceutical supply chain.
1. Leverage Industry Expertise
In his role, Meakin’s primary responsibility is to lead the compliance agenda by driving compliance and governance through the business. This includes regulatory intelligence, communicating new guidelines, and also new legislation. To keep up with the high volume of legislation and regulations from around the globe, he and other experts in DHL’s regulatory compliance and risk (RCR) group ensure they leverage industry expertise by becoming members of organizations, such as ISPE, TOPRA, RAPS, PDA, European Association for Logistics and Transportation in Healthcare (EALTH), and other organizations for professional regulatory affairs.
“From all of those organizations, we get the updates, such as from newsletters, and from that, we're able to keep up to speed with all of the information in different geographies,” explains Meakin. “By ensuring that you have experts on staff who are joining these organizations or communicating with them, everyone remains in the loop.” DHL has over 70 Pharmacists as well as a number of Qualified Persons to comply with GMP.
Meakin says he also utilizes the company’s “Yellow Book,” which is an internal document that cross references rules with all of the international standards. By mapping international guidelines to the various regulations, the Yellow Book offers another way to keep Meakin and his team up to speed.
2. Know Your Route
Proactive planning is also key to ensuring compliance along the route of your supply chain, which Meakin says should be reviewed thoroughly ahead of time in order to anticipate any challenges. “Routes should be qualified and validated with risk assessments,” explains Meakin. “Drivers have to be properly trained and equipment has to be qualified. That means some of the transport equipment will need to be stress tested and put in climatic chambers, which involves reducing the temperature in a chamber down to -30 or -40 degrees and then checking that the equipment works under those extreme conditions. This also includes taking the equipment out for long periods of time, testing it, and going on the road to complete performance qualifications.”
When simply shipping general cargo, this doesn’t happen, but with pharmaceuticals, risk assessments become quite a big subject. “You need to have evidence that you've done some sort of scientific risk to back up whatever decisions or processes you operate,” explains Meakin.
3. Qualify Your Customers
While many companies make it a point to qualify their suppliers, Meakin says qualifying your customers is just as important. “When it comes to counterfeit shippers, there’s a requirement for distributors to monitor the transactions of their customers, especially where it deals with narcotics,” says Meakin. “There’s always been a requirement that you can only ship to a bona fide, licensed premise. The idea is it goes from a licensed drug facility to another licensed facility, such as a warehouse, hospital, or to a doctor or clinic.”
Administering this with other customers and agencies can be quite a challenge. To aid in the global effort to stop counterfeit drugs from entering the supply chain, Meakin believes regulatory requirements should include putting an emphasis on distributors that ensures they’re checking their own product websites and monitoring unusual ordering patterns. He cites the recent example of the indictment of FedEx by a grand jury for supplying shipping services to fake online pharmacies. Even after being warned by Congress in 2004, the company continued these practices and now faces more than $820 million in fines for their misconduct.
Meakin says another grey area is around brokerage; someone who didn’t actually make the product but might appear as having a license to make it, because they were subcontracted. “These middle men, or brokers, have to comply to the same GDPs, even if they didn’t fit, pack, or make a single product. They’re all part of the supply chain. Otherwise, there’s a way of operating where it’s just the people who are doing the physical activity that have to comply,” explains Meakin. “If you have a vertically integrated supply chain process, you might think you’re not included in the regulations, but there’s a risk that some people now fall into the regulations who didn’t previously. Basically, you have to know what you’re doing; otherwise, you might find yourself being hit with some sort of prosecution or your customers seeing you as a liability or risk to do business with. It’s just a matter of understanding who both your customers and suppliers are.”