Globally Harmonized System of Classification and Labeling of Chemicals (GHS) addresses the classification of chemicals by types of hazard and proposes harmonized hazard communication elements, including labels and safety data sheets. (more…)
Archive for the ‘Knowledge Base’ Category
Aug 3rd
Understanding ePedigree and Serialization
‘ePedigree’ and ‘Serialization’ have become hot topics in the world of pharmaceutical and medical device tracking. But how many of us really understand the difference between the two? (more…)
Aug 2nd
Choosing Your Method: RFID vs. Barcodes
At the heart of tracking pharmaceuticals, clinical trials and medical devices is the debate about whether to use barcodes or RFID tags. Both have their advantages and disadvantages, and there really isn’t a clear winner. It’s a matter of understanding your circumstances and knowing which method will deliver the best results for your organization. (more…)
Jun 7th
What is UDI ?
The FDA’s mandate for Unique Device Identification (UDI) of medical devices aims to offer a practical solution which proposes a standard way of presenting standard information in a standard format or barcode. (more…)
May 26th
What is so difficult about pharmaceutical Serialization?
Though the principles of serialization are fairly straight forward, there’s more to serialization than just generating numbers. Especially in the tightly regulated and compliance-led world of pharmaceutical manufacturing and packaging. (more…)
May 7th
What is NPSA
The National Patient Safety Agency (NPSA) leads and contributes to improved, safe patient care by informing, supporting and influencing the health sector. It represents a body of the Department of Health which aims to reduce risks to patient safety in UK health service by overseeing techniques and guidelines that help in proper patient identification. (more…)
May 6th
Pharmaceutical Serialization
Counterfeit drug revenues are estimated to be in the region of $75 Billion in 2010 and are projected to grow at 13% annually. The World Health Organisation states that it is impossible to quantify the size of the problem but that it may be as much as 10% of the global market. (more…)
Mar 14th
What is GMP ?
Good Manufacturing Practice, GMP compliance, is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMP standards are concerned with both production and quality control. (more…)
Feb 1st
What is FDA
The Food and Drug Administration (FDA) governs health and human services in the United States. It protects public health by enforcing safety and security regulations for drugs, vaccines, and other biological products and medical equipment. (more…)
