As reported by GMPTrainingsystems, FDA Focuses on Supply Chain, which included an excerpt from Dr. Sharfstein, MD, FDA Principal Deputy Commissioner, where he addressed the safety of the supply chain on Oct 22, 2009. Dr. Sharfstein stated:
“What keeps Dr. Hamburg and me up at night should worry you as well – the safety of the supply chain in an increasingly globalized world. There are criminals out there who will dilute your ingredients with dangerous additives – from melamine to diethylene glycol to lead and arsenic. There are criminals who might claim to sell you one chemical and actually provide another. Because you are ultimately responsible for the product you put on the market and its impact on consumers, every company should be responsible for where you are purchasing ingredients.”
5-years later and we continue to see supply chain issues, and the negative impact of lack of supply or lack of quality supply has on our ability to keep a safe supply of drugs available for the public. As I blogged previously, the lack of data integrity, the instances of data manipulation, testing product into compliance seems to be on the increase. See the following recent example:
On July 9, in a USFDA warning letter to Zgejiang Jiuzhour Pharmaceutical Co., Ltd the FDA cited the following:
Your trading company, hereafter referred to as Zonebanner, purchased APIs from an outside supplier and relabeled them without the oversight of a quality unit. The information from the original certificate of analysis, generated by the actual manufacturer, was transferred to a new certificate of analysis on Zhejiang Jiuzhou Pharmaceutical Co. letterhead with no information about the original manufacturer or analytical laboratory performing the analyses. In addition, a new label identifying Zhejiang Jiuzhou Pharmaceutical Co. as the manufacturer was added to drums. In doing so, your firm essentially obscured the supply chain of these APIs [bold added for emphasis].
Zonebanner had no quality system in place for the relabeling operations. In addition, we note that in at least one instance of a lot of gabapentin shipped to the U.S., the retest date from the original manufacturer’s certificate of analysis (November 2013) was changed to an expiration date listed as eleven months later (October 2014) on the new certificate of analysis.
In this case the repackaging of the API obscured the supply chain, and by changing the retest date may have allowed expired APIs to have been used in the manufacture of pharmaceuticals.