Recently I contacted Dirk Rodgers from RxTrace (rxtrace.com) and asked him a few questions. He was kind enough to get back to me.
Standard Operating Procedures (SOP) are common documents that outline step-by-step processes to achieve overall results of a longer overall process. Even though it is not a requirement from the DSCSA to have a product tracing SOP, we have noticed that during a few audits, most auditors are requesting for one. We decided to create a simple Product Tracing SOP for you to build upon.
The Drug Supply Chain Security Act (DSCSA) November 2017 deadline is approaching fast, perhaps too fast for some companies. Even if the largest players have prepared and tested their serialization solutions ahead of time, the industry as a whole is far from being ready on time. Some reports suggest many companies need 12-24 months more to implement serialization; a fraction of the market has not started yet. The latter believe the FDA would postpone the deadline. Should the deadline be postponed or not, serialization implementation is an endeavor of an extraordinary magnitude.
Everyone involved in the supply of drugs, from the moment of manufacture to the purchase of the finished drug by the end user, must be aware of the need for accuracy and perfect performance throughout the process. Most drugs are supplied faultlessly; unfortunately, in a small number of cases supply is fraudulent or illegal and the Drug Supply Chain Security Act (DSCSA) was passed to stamp out such fraudulent and illegal practices and ensure the safety of consumers.
The FDA has released their guidance plan for what guidance documents they will release in 2016. Let’s examine each one:
As we prepare for the new DSCSA March 1st deadline, it is probably a good idea to become familiar with what most DSCSA terms mean. Terms such as “Trading Partners” or “Suspect Product”. Here are few popular definition terms:
One of the reasons we have a Drug Supply Chain Security Act (DSCSA) is that supply of counterfeit prescription drugs has grown to huge proportions. The FDA Counterfeit Drug Task Force reported ten years ago that “the FDA has seen growing evidence of efforts around the world by increasingly well-organized counterfeiters backed by sophisticated technologies and criminal operations to profit from drug counterfeiting” and there is evidence that the problem has multiplied in the past decade.
When DSCSA was passed into law, certain requirements were laid on all the elements in the distribution chain for prescription drugs but, for the most part, the method of implementation was left to the individual parts of the chain to negotiate and agree amongst themselves. One area of uncertainty is the Saleable Returns verification method, which has to be in place by November 2019. The end of 2019 seemed a long way in the future when the Act was passed but seems so no longer. There is disagreement on what the supply chain should be doing now.
According to McKinsey Corp, “Up to half the cost of many supply chains lurks ignored and unmanaged in outbound logistics and behind the closed doors of distribution centers.” A European study put logistics at 12 percent of the total cost in manufacturing and more than 20 percent in the retail sector, but McKinsey says, “Pharma logistics represent about 2 percent of sales, or 7 to 8 percent of the cost of goods sold,” though it goes on to say that this is less than in other industries and points out that the outbound supply chain is often outsourced.