What do industry leaders think of Pharmaceutical serialization?

How helpful will pharmaceutical serialization be to manufacturers and patients? With serialization now set to upshot the industry in the arrangement of a key part of the Drug Supply Chain Security. The major incentive behind serialization is to help defend patients from contact with drugs that may be an imitation, stolen, contaminated, or else damaging is noticeable of serious importance. Any system intended to advance the detection and elimination of possibly dangerous drugs from the drug supply chain is valuable. Serialization is the allocating of a unique serial number to each commercial unit of each remedy product, which has associated with information about the product's source, batch number, and expiration date. The units can be tracked through its whole supply chain, from production to selling distribution to the final special consideration to the patient

Here in this article, we will look at what are the key points of Pharmaceutical Serialization.

The Serialization Mandate

Phase One: It has started January 1, 2015, needs pharmaceutical supply chain contributors to share lot-level transaction data, transaction history, and transaction reports at each sale/transfer of possession.

Phase Two: It has executed no later than November 27, 2017, will need that manufacturers serialize all products with a distinctive serialized identifier at the viable unit level. Each item must be preserved as a unique serialized item that can be tracked separately. Precisely, pharmaceuticals must be signed with a National Drug Code, serial number, lot number, and expiration date in both device-readable and human-readable format.

Phase Three: It needs trading partners to share chain-of-ownership data in a manner that permits for serialized entity traceability back to the origin.

Evaluating the Thoughts of Industry Leaders

A 10-question assessment of serialization and anti-counterfeiting in the pharmaceutical industry have offered to members at the Pharmaceutical Traceability Medium. The 26 defendants were key administrators and leaders involved in serialization, anti-counterfeiting, and packaging inventiveness. This model size is an illustration of a small ecosystem that is an extremely specialized group of a limited hundred in all of the pharmaceutical industry.

Key Findings of Survey

 Serialization is not inspirational pure enthusiasm. There was a shockingly less-than-enthusiastic reply about the value of serialization as a tool to help guard patients. Only 12 percent of survey defendants agree that “Serialization is going well and will be beneficial when finalized” and only 41 percent agree that “Serialization is perplexing to complete and will likely be valuable when finalized.”

 Serialization alone has not been appreciated as sufficient to guard patients. 85% of survey respondents agree that more requirements to be done to protect patients and 63% agree that fraudsters are getting well at copying packaging. 36% agree merging multiple technologies is the most significant tool to reduce the risk of counterfeits while 16% agree that serialization is going acceptable but is not going to be enough to stop counterfeits in the market.

 The packaging is weak. 65% of respondents consider that counterfeiters are getting well at incorporating anti-counterfeiting technology into counterfeits and 63% agree that counterfeiters are getting better at copying packaging.

Key Point

 Even with some uncertainties, serialization is still significant: 88% of respondents have considered, Serialization is vital for approving the security of pharmaceutical products.

 Serialization is not sufficient on its own. The survey outcomes also noticeably show that in and of itself, serialization is likely to fall short of the complete goal of keeping the pharmaceutical supply chain at liberty and clear of counterfeit drugs. There is an extensive feeling that at the very smallest, serialization must be joined with other approaches to have more security in the supply chain.

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