Pharma cold chain monitoring technology has come a long way since manual data collection. We now have wireless data loggers that collect data and can automatically synchronize it to a central monitoring platform. These products have made the collection and Read more…
What does the FDA requirements 21 CFR Part 11 stand for? It is important to understand it for medical device developers, who are considering entering the US market. There are lots of requirements and regulations in this huge and complex Read more…
In previous blog posts, we have explored the fact that many drugs, vaccines and pharmaceutical products require refrigerated conditions in order to maintain efficacy. We also examined the importance of minimizing temperature excursions during transportation. Establishing a drug stability budget can minimize discards Read more…
Background The World Health Organization (WHO) publish guidance for the storage and transport of temperature sensitive pharmaceutical products. Many pharmaceuticals, drugs and vaccines have time and/or temperature-dependent requirements. The WHO guidelines are based upon existing worldwide regulations and best practices. Read more…
The quality of pharmaceuticals relies on the environment controls during its storage and handling. Every pharmaceutical item ought to be taken care of and stored under manufacturer-recommended storage condition marked on data information sheet or packaging. Temperature Excursion Management in Pharmaceutical Read more…
Ensuring proper storage of pharmaceutical products, in accordance with the manufacturers’ specifications, is crucial for the stability of products. The conditions should be consistent throughout the cold chain. Poor temperature control undermines the efficacy of the drugs. Improper storage conditions Read more…
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