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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.

FDA has not addressed discrepancies or the need for changes to correct information in TI/TH/TS. Certainly the DSCSA requires that accurate TI/TH/TS be passed, received and stored, so if errors are discovered, they need to be corrected. In the HDMA ASN Exceptions Guidelines for the Drug Supply Chain Security Act (“ASN Exceptions Guidelines”), HDMA describes various scenarios in which there is a discrepancy or error in TI/TH/TS, and proposed responses/corrective actions.

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:

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.