


Navigating Misalignment Exception Management Under DSCSA: Challenges and Solutions
Feb 28, 2025 |
The U.S. Drug Supply Chain Security Act (DSCSA) aims to enhance pharmaceutical traceability, but misalignment exceptions remain a persistent challenge....
Italy's Transition from Bollino to EU-FMD: Proposed Deadline Extension and Industry Implications
Feb 7, 2025 | Serialization, Regulations
Reference: 19th Legislature - 10th Permanent Commission - Summary report no. 247 of 26/11/2024 (Accessed on February 6, 2025....
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...
Pharmaceutical Serialization in the GCC: Progress, Challenges, and Future Directions
Jan 17, 2025 | Serialization
Pharmaceutical serialization, a cornerstone of supply chain security, is rapidly advancing across the Gulf Cooperation Council (GCC) countries. This...
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....