To avoid product counterfeits in pharmaceuticals and medical devices, new track and trace regulations are being introduced. Oliver describes latest trends, c...
New Delhi, May 5 (PTI) Government has developed a 'Track and Trace' mechanism to check the authenticity of medicines being sold and stored in the country, Health and Family Welfare Minister JP Nadda today informed Rajya Sabha. "The primary, secondary and tertiary packs of medicines will have a unique bar code allotted to a particular manufacturer. The data relating to all medicinal products will be available on the Internet and any person having access to the Internet would be able to cross check the authenticity of the medicines," the minister said. There is no proposal to introduce such a mechanism for medical devices.
The ruling, a result of close to a decade of research and development, is designed to improve and enhanced the quality of information and tracking of medical devices. The unique UDI, a numeric or alphanumeric code, will identify the device identifier—or the labeler—and production identifier, which can serve to identify particular information about the device itself such as the batch number, the serial number, the expiration date or manufacturing date of the specific device. This information will allow the medical system to identify a device through distribution and use. The future of each UDI is the accuracy of the FDA’s Global Unique Device Identification Database (GUDID).
If things go as planned, the Centre plans to amend the Drugs & Cosmetics Act and rules to modify it as per the submitted recommendations in the coming months. Task Force, which was chaired by Dr H G Koshia, commissioner of Gujarat FDCA, had submitted its recommendation on the requirement for adopting an effective track and trace system in 2012. As per the recommendation, all the domestic manufacturers will soon have to incorporate bar coding and Unique Identification Number (UIN) in every pack of medicine, so that it will enable effective tracking of the products right from its inception stage to the delivery point.
Proliferation of dangerous counterfeit medication is a global concern. Impending regulations across markets will require pharmaceutical, medical device and consumer packaged goods manufacturers to trace products down to the individual saleable unit across the supply chain. Rockwell Automation has introduced its new holistic serialization solution to help manufacturers comply with these regulations. The offering can strengthen supply chains and produce a number of business benefits beyond compliance.
SCHOTT North America announced that its new oval glass tubes for photobioreactors (PBRs) increased maximum dry biomass output per day by more than 22 percent in its latest study in partnership with Heliae, a technology-driven algae production company. For the first time, SCHOTT’s round glass tubes were retrofitted with oval tubes in Heliae’s Helix™ seed PBR. An indoor study over multiple cycles in several months found that the algae growth rate per volume increased by more than 45 percent, while the oval shape reduces the total internal volume of PBR tubes by 15 percent compared to standard circular tubes resulting in the overall output-increase stated above.
A track and trace system tracks a product through all phases of manufacturing and provides a trace of the product’s lifecycle from the plant to the customer.
As short-term problems and costs creep up, it can be harder to see serialization's ROI. It can also be difficult for managers to see compelling long-term reasons why the technology is so necessary. There can be a tendency to focus on cost-cutting, which often leads to project failure. At this point, relatively few pharma companies see the reason for developing clear serialization strategies. This is particularly true for contract manufacturing organizations (CMOs), who need to keep operations as simple and flexible as possible, to adjust to the needs of many, varied international clients and projects.
For my last column, I decided to provide you with my personal predictions about pharmaceutical serialization and traceability over the next few years. Please do not count on these things happening. They are only predictions. See if you agree.
In a nutshell, the insertion of Paragraph 2.89 A in the Handbook of Procedure for the track and trace system means that labelling - covering the Global Trade Item Number (GTIN), batch number, expiry date and a unique serial number - has to be available on the primary packaging in human-readable form. The need to incorporate the data in a bar code has been exempted until further notice, but companies have already expressed concerns about the short timeframe for compliance, the cost and necessity of including this data on primary packaging and possible space constraint problems associated with the printing of human-readable data.
One way to fight counterfeit medicines is through product serialization. The U.S. FDA’s Drug Quality and Security Act (DQSA), also known as Drug Supply Chain Security Act (DSCSA), mandates that by May of this year, all U.S. pharmaceutical companies must capture the transaction history and movement of their products through the supply chain, and store that information for at least six years. By November 2017, that information must be available electronically, and the product identifier, or its serial number, must be affixed or imprinted on the label. Other countries have or are proposing similar regulations.
The Industrial Internet Consortium (IIC) will enable and accelerate creation of the Industrial Internet which is essential to US competitiveness in key industry sectors, including: manufacturing, transportation, energy, healthcare, buildings, utility infrastructure, defense, and emergency response.
MBBP client The Industrial Internet Consortium (IIC), a non-profit group whose mission is to accelerate growth of the Industrial Internet by identifying, assembling and promoting best practices, has announced the release of the Track and Trace testbed. The goal of this project is to manage handheld power tools in manufacturing and maintenance environments by efficiently tracking and tracing the usage of these tools for proper use.
The U.S. Food and Drug Administration issued guidance for the Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, and Prescription Drugs. The document establishes initial standards for the interoperable exchange of product tracing information (transaction history (TH), transaction statement (TS), transaction information (TI) in paper or electronic format.
The SAP Global Batch Traceability (SAP GBT) application provides a view on a cross-system product genealogy and its distribution. It reduces the time to insight into your product batch network and enables rapid investigation and, when required, precision withdrawal and recall. The track and trace data managed by SAP GBT has additional value, providing the foundation for timely regulatory reporting imposed on organizations that produce goods.
MDDTrack™ is a patented technology for Unique Device Identification (UDI) that provides complete item-level tracking and tracing via unique URLs. Our approach allows an unlimited amount of data to be collected and shared securely throughout the supply chain using geolocation to ensure compliance with a local regulation. This gives manufacturers the tools for item-level risk management, real-time customer and product interaction, and recall and compliance management worldwide.
Glass bottles and containers remain a popular packaging option due to a number of reasons including product differentiation and identification of a premium product. In addition, its reuse (returnable bottles) and recyclability make it an environmentally good choice. Glass bottles are popular for a variety of food and beverage products and those that require a strong barrier protection.
FI-STAR’s pharmacy and surgery applications are using FI-WARE open software to offer innovative health care services. Munich Surgery and Leeds Pharmacy teams have jointly forged a generic reverse-supply-chain system that provides for bi-directional interaction of multiple stakeholders using medical prescriptions and surgical instruments. These applications are being tested in the real worlds of the Operating Theatre and Pharmacies in Munich and Leeds.
The WHO’s latest report on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has the organization divvying up certain responsibilities for controlling the fraudulent products between countries.
Fake drugs or counterfeit drugs have not been defined under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. However, reports, largely unsubstantiated, continue to appear in media about the extent of spurious/adulterated drugs from time to time.
The first webinar in the series, US DSCSA Serialization: Why Now will be held on Wednesday February 18 at 11:00AM EST. The live session will provide drug manufacturers, contract manufacturing organizations (CMOs), contract packaging organizations (CPOs), and repackagers with an overview of US DSCSA serialization requirements; global serialization regulations impacting US serialization planning; key learnings from TraceLink serialization projects; and a roadmap that underscores the 24-month lead time needed for a successful serialization implementation.
BEEYOND is a consulting company in the field of disruptive innovation, accompanying established companies on out-of-the-core growth strategy, from creation of new concepts to product launch. Reach us at: contact@beeyond.fr.
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