The tracking systems resulting from DSCSA will complement the drug design control process, which includes guidelines that companies must follow in order to enter ingredients into the supply chain.

The Drug Supply Chain Security Act (DSCSA) was first signed in to law four years ago. It “outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.”

A significant number of DSCSA’s deadlines are set for late 2017. The DSCSA mandates that manufacturers begin serializing all U.S. prescription drug products, both saleable units and homogenized case level units by November 27, 2017. The milestones reached in 2017 will mark the half-way point to the ultimate goal, which must be met in 2023: the serialization of all items (ingredients) of a drug to allow supply chain partners to trace the ownership of ingredients to their beginning or manufacturing.

Ensuring Both Quality and Safety

While the act could lead to more levels of administrative work for drug manufacturers and their ingredient suppliers, the resulting logistical verification system for a drug’s supply chain is designed to protect consumers from counterfeit products and to ensure quality and safety in pharmaceutical products. This coding system will also enable companies to speed up activities associated with a drug recall.

In 2017, drug manufacturers and repackagers will be required to code packages using a product identifier, serial number, lot number, and expiration date. By November 27, drug manufacturers must have instituted or completed the following:

• Serialize by placing a unique product identifier to each unit and sealed homogenous case
• Provide the transaction information to trading partners only in electronic format: transaction history and transaction statement
• Respond to a trading partner’s request for product identifier information within 24 hours
• Verify the product identifier of any returned product that the company intends for resale
• Maintain product identifier information for a product for up to six years after transaction date

After meeting the deadlines for 2017, drug manufacturers also have deadlines that they must meet in 2018, 2019, and 2020 leading up to 2023.

Validating Approved Ingredients

According to the DSCSA, a product identifier is “a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.” In layman’s terminology, the coding must include a barcode.

The tracking system that will result from the DSCSA guidelines will complement the drug design control process, which includes a set of guidelines companies are required to follow in order to qualify ingredients for a drug and for approval of ingredients in order to go into the supply chain. At this point, the DSCSA coding becomes a tracking bill of materials that validates that the ongoing use of approved ingredients from the design control process are being used during the drug production process.

Supplier Control

As for which federal guidelines DSCSA will complement the most, the DSCSA should be a good companion to supplier control within the pharmaceutical “ICH Q” structure for CMC. However, it is the upcoming ICH Q-12 guideline that should see the most synergy with DSCSA. ICH Q-12 is a risk-based guideline that is coming out for pharmaceutical products later this year and would be vindicated by support of the supply-chain coding concept.

No Discrimination or Favoritism

Depending upon a person’s perspective, the DSCSA does not discriminate or show favoritism because its numerical coding tracking condition will have to be followed by all organizations, regardless of size, who feed a drug’s supply chain. The DSCSA and other resources, such as the GS1 Electronic Product Code Information Service (EPCIS) and Core Business Vocabulary (CBV), will result in improved communication between the companies in the supply chain as they share information about the physical movement and status of ingredients.

A good example of how the tracking system will work and its benefits are outlined in this possible scenario:

A manufacturer in New York produces a drug that has an active pharmaceutical ingredient (API) that is distributed by a company in California and is produced by another company in Taiwan.

The DSCSA mandated coding system will allow tracking of the API as it goes through the various steps at all three of the companies as the new batches of the drug are produced. The coding system will verify that a drug batch is produced the same way every time unless it goes through a change control, and the coding then would reflect that change.  

The DSCSA’s overarching purpose is to reduce risk to the users of drugs. Of course, by closely monitoring the supply chain, the risks associated with a change of ingredients can be mitigated by knowing a change has occurred and what that change is.

Mitigating Risk in Supply Chain

A good frame of reference on how the DSCSA coding system will work is N17 — the medical device version of supplier control. N17 is a good reference as to how DSCSA works because it mitigates risks for a medical device supply chain in the same way DSCSA will in the drug supply chain. Here is an example of how N17 reduces risk for users of a medical device by verifying that approved materials are being used in the production process by the manufacturer and the suppliers:

A company produces a class-3 medical device that is an implantable into the human body, and the device consists of multiple moving and stationary parts. All of the device components are designed and coated with materials to withstand body fluids of varying pH levels. During the supply chain process, a supplier of one of the components institutes changes to coating conditions. N17 tracking will capture this change if it is entered, allowing the manufacturer of the medical device to know of the change and to make the appropriate adjustments to the medical device design, production or distribution process.

Similar to N17, the DSCSA will include information in it about which companies were sourced to provide ingredients, who was qualified, and who was selected. The coding system will capture any changes to the normal production process.

Tracking Suppliers’ Sub-Suppliers

One of the intended results is that manufacturers will not arbitrarily jump to different suppliers. It is also important to note that the manufacturer will also be able to track that its suppliers’ sub-suppliers are not making changes to the ingredients. The coding system will allow manufacturers to review detailed information for multiple sub-contractors for an ingredient and the conditions under which the ingredient was produced. All this tracking should greatly reduce the risk of harmful (fraudulent) ingredients entering into a drug’s supply chain and ultimately making it into the hands of a consumer or patient.

It must be noted at this point that consumers are not the only ones who will benefit from the reduction of risk associated with coding the supply chain. Manufacturers benefit, too, because they will have better vigilance of components (APIs), allowing them to lessen the likelihood of financial losses associated with recalls and lawsuits that could result from a tainted drug batch leaving the production floor and reaching the medicine cabinets of consumers. Of course, one of the biggest benefits to following the DSCSA guidelines, as well as requirements for technology transfer and post-market feedback, is the ability to avoid being denied FDA approval due to not following the rules.

The FDA released the final version of the DSCSA 2016 guidance document in December and quickly followed that with the draft of the 2017 guidance in January.

About the Author: Walt Murray, ICLA, CSSMBB, is President and CEO of ARC Experts. With more than 32 years of experience working with highly-regulated companies, Murray is a CQEH&S Lead Auditor and is certified in quality and environmental systems auditing (AQS Systems), Critical-Thinking Skills (CTS – Alamo Learning Systems), and process control and improvement.

This feature story can also be found in the April/May 2017 issue of Pharmaceutical Processing. 

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