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631 Results
Section: Logistics > Traceability/Serialization
Traceability/Serialization
Track-and-Trace Market Predicted to Soar Through 2025
DSCSA’s Nov. 26, 2018 deadline for unit-level product identifiers is fast-approaching, but serialization and track and trace will remain relevant for years to come.
June 13, 2018
DSCSA’s Nov. 26, 2018 deadline for unit-level product identifiers is fast-approaching, but serialization and track and trace will remain relevant for years to come.
Traceability/Serialization
Six Months to DSCSA Enforcement Date
As the enforcement date for unit-level product identifiers nears, challenges lie ahead for manufacturers and the industry as a whole.
May 25, 2018
As the enforcement date for unit-level product identifiers is approaching in six months, challenges lie ahead for manufacturers and the industry as a whole.
Pharmaceuticals
Barcode Integrity Crucial for Brand Authentication, Anti-Counterfeiting and Regulatory Compliance
Industry assessments are demonstrating that using verifiable, standards-based barcodes to improve traceability, block counterfeits and address regulation requirements will also enable operational, economic and patient safety improvements.
May 15, 2018
A barcode assessment conducted by AmerisourceBergen and McKesson Pharmaceutical, in collaboration with GS1 Healthcare US—just six months before the November 2017 deadline—found only 6.6 percent of 16,618 pharmaceutical packages scanned met the DSCSA requirement for a readable barcode with four data elements.
Traceability/Serialization
CPO Maintains Tailored Approach Adding Level 5 Serialization System
allpack offers customers greater flexibility and scale with a cloud-based system that maintains customer focus while managing and exchanging data for serialization compliance.
May 10, 2018
Independent contract packaging organization (CPO) allpack focuses solely on the pharmaceutical sector, offering clinical and commercial packaging services ranging from small volume to large lot sizes.
Traceability/Serialization
FDA: Guidance on DSCSA Waivers
New eight-page draft guidance helps trading partners understand the process for requesting waivers, exceptions and exemptions from DSCSA product identifier requirements.
May 9, 2018
New eight-page draft guidance helps trading partners understand the process for requesting waivers, exceptions and exemptions from DSCSA product identifier requirements.
Traceability/Serialization
Of Trees and Traceability
Intelligent supply chains have the potential to improve efficiency at the natural resource level and create opportunity for OEMs. Can people look beyond the next fiscal quarter?
May 2, 2018
The ability to trace and sort raw materials can allow for items of specific quality go to the transformers (manufacturers) who need that level of quality, ultimately reducing waste.
Pharmaceuticals
Examining the Properties of TIJ Fluids and Their Role in Serialization
Editor’s note: Part I of a two-part series addresses issues pertaining to the color fastness of CIJ ink.
April 26, 2018
Domino has developed several inks, including this BK640 ink cartridge, for 2D coding.
Traceability/Serialization
New OIG Report Calls for FDA Education for Pharma Dispensers
In a review of 40 pharmaceutical dispensers, an OIG study shows that most received all drug product tracing details from their trading partners, but more work needs to be done.
April 13, 2018
In a review of 40 pharmaceutical dispensers, an OIG study shows that most received all drug product tracing details from their trading partners, but more work needs to be done.
Supply Chain
Unusable Barcodes Present Troubling Compliance Issue
GS1 US, AmerisourceBergen and McKesson assessment of DSCSA serialization implementation progress reveals barcode readability issues.
March 19, 2018
GS1 US, AmerisourceBergen and McKesson assessment of DSCSA serialization implementation progress reveals barcode readability issues.
Pharmaceuticals
RFID, Carton Serialization Boost Track-and-Trace Market
New report predicts an 18.9% CAGR for track-and-trace solutions through 2023, but high costs and a lack of standards will likely hinder growth.
March 12, 2018
New report predicts an 18.9% CAGR for track-and-trace solutions through 2023, but high costs and a lack of standards will likely hinder growth.
Traceability/Serialization
FDA: Two New Track and Trace Guidance Docs
The documents are part of FDA’s effort to standardize terms to ensure data is captured and shared in a way that facilitates communication between supply chain partners.
March 5, 2018
The documents are part of FDA’s effort to standardize terms to ensure data is captured and shared in a way that facilitates communication between supply chain partners.
Pharmaceuticals
Coating Technology Resolves Serialization Issue
Platinum Press works with its suppliers to eliminate a problem customers had experienced with serialized codes rubbing off booklet-style labels.
February 21, 2018
Akorn partnered with Platinum Press to produce readable, serialized labels, as shown in this rendered image.
Pharmaceuticals
HDA, ValueCentric Announce API Certification for Origin
Origin is a source of GTIN reference data for the pharmaceutical industry. Adents represents the first partner to go through the certification process.
February 16, 2018
Origin is a source of GTIN reference data for the pharmaceutical industry. Adents represents the first partner to go through the certification process.
Traceability/Serialization
Survey Reveals Serialization’s Potential Across Industries
New survey reports that companies across different industries consider the most important advantages of serialization to be protection against brand and product piracy and greater transparency in the logistics chain.
February 13, 2018
New survey reports that companies across different industries consider the most important advantages of serialization to be protection against brand and product piracy and greater transparency in the logistics chain.
Pharmaceuticals
Carton Serialization Helps Idifarma Meet EU Falsified Medicines Directive
Spanish contract development and manufacturing organization (CDMO) Idifarma makes €200k investment to meet forthcoming EU serialization regulations.
February 7, 2018
Spanish contract development and manufacturing organization (CDMO) Idifarma makes €200k investment to meet forthcoming EU serialization regulations.
Pharmaceuticals
TraceLink Dismisses Litigation Claims Against HDA
TraceLink and HDA will work together with other industry players to propose interoperable standards and guidelines for pharmaceutical product master data, with the purpose of enabling compliance with the DSCSA.
February 6, 2018
TraceLink and HDA will work together with other industry players to propose interoperable standards and guidelines for pharmaceutical product master data, with the purpose of enabling compliance with the DSCSA.
Traceability/Serialization
Verification Router Service Update
As an outgrowth of the Healthcare Distribution Alliance's 2019 saleable returns pilot work, the group has been exploring a VRS as an option for compliance to support DSCSA verification requirements.
February 6, 2018
A VRS could be used to manage acceptance, formatting and delivery of requests/responses to support DSCSA verification requirements (Credit: HDA)
Pharmaceuticals
OPEN-SCS Group Addresses DSCSA Transaction Documentation
Lack of packaging standards could threaten serialization data integrity, says speaker during FDA meeting on drug distribution security.
January 25, 2018
Dirk Rodgers speaks at recent FDA public meeting on enhanced drug distribution security.
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