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Italy’s Transition from Bollino to FMD: Challenges and Preparation Guide for Pharmaceutical Manufacturers
Jan 24, 2025 | Serialization, Regulations
Italy is embarking on a significant shift in its pharmaceutical regulation by transitioning from the Bollino system to the European Union’s Falsified...
Overview of Indonesia’s Pharmaceutical Serialization Regulations
Jan 3, 2025 | Serialization, Pharmaceutical, Regulations, Compliance
The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) or Badan POM, also known as the Indonesian FDA, is a government agency in...
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....
How effective is your EMVO Alert Management Strategy?
Nov 15, 2024 | Serialization, Regulations, Counterfeit
Introduction
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?