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US Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions - WEE’s
Dec 20, 2024 | Serialization, Pharmaceutical, Regulations, Compliance
The US DSCSA, enacted in 2013, aims to create a system for tracking prescription drugs as they are distributed within the United States. The act is...
The Importance of Master Data Management in Pharmaceutical Track & Trace
Dec 13, 2024 | Serialization, Pharmaceutical, Regulations, Compliance
Serialization involves assigning serial numbers to products or packaging units, requiring a defined set of attributes for tracking and tracing. Master...
CSV in Pharmaceuticals: Challenges and Solutions
Dec 6, 2024 | Serialization, Pharmaceutical, Regulations, Compliance
Pharmaceutical manufacturers face several challenges specific to Computer System Validation (CSV) due to the industry's stringent regulatory and...
UAE TATMEEN - Pharmaceutical Drug Traceability
Nov 22, 2024 | Serialization, Pharmaceutical, Regulations, Compliance, Aggregation
The UAE Ministry of Health and Prevention issued Legislative Decree No. (73) of 2021 on June 14, 2021, regarding Pharmaceutical Products Traceability....
Battling Counterfeit Medicines in Africa: Leveraging Technology for a Safer Supply Chain
Nov 8, 2024 | Serialization, Pharmaceutical, Regulations, Compliance
Fake medicines kill almost 500,000 sub-Saharan Africans a year: UNODC report.
US DSCSA – Misalignment Exceptions
Oct 11, 2024 | Serialization, Pharmaceutical, Regulations, Compliance
Will the US DSCSA misalignment exception disrupt your supply chain?
WHY IS ITALY MOVING FROM BOLLINO SYSTEM TO EU FMD
Oct 4, 2024 | Serialization, Pharmaceutical, Regulations, Compliance
Italy's Transition from Bollino to EU FMD for pharmaceutical serialization and traceability: A Move Toward Safer and More Efficient Healthcare!
Insights from Indonesia's Serialization Pilot Project: A Comprehensive Overview
Sep 6, 2024 | Serialization, Pharmaceutical, Regulations, Compliance
The pharmaceutical serialization initiatives in Indonesia have been part of a broader regulatory effort led by the Indonesian National Agency of Drug and...
Preparing for Serialization in Indonesia
Aug 23, 2024 | Serialization, Pharmaceutical, Regulations, Compliance
Introduction to Regulation