0Good Manufacturing Practice (GMP)Knowledge BaseQuality OriginsThe origins of robust pharmaceutical quality: Contaminated Infusion FluidsA blog on the origins of robust pharmaceutical quality, this blog focuses on the Report of the Committee appointed to inquire into the circumstances, including the production, which led to the use of contaminated infusion fluids in the Devonport Section... April 24, 2023Read more
Knowledge BaseQuality System ElementsThe Critical Role of Proper Deviation ManagementIn the highly competitive and regulated world of manufacturing, maintaining product quality, safety, and efficacy is essential for the success of any organization. One key aspect that plays a pivotal role in achieving this is proper deviation management. Deviations are... April 20, 2023Read more
Knowledge BaseQuality OriginsOrigins of robust pharmaceutical quality: The Elixir Sulfanilamide disasterThe Elixir Sulfanilamide disaster was a tragic event that occurred in 1937, resulting in the deaths of over 100 people, many of them children. The tragedy revealed the inadequacies of the pharmaceutical regulatory framework at the time and led to... April 18, 2023Read more
0Good Manufacturing Practice (GMP)Knowledge BaseWhy is Quality so Important in Vaccine Production?The pharmaceutical industry plays a critical role in improving public health by developing and manufacturing drugs and vaccines. One of the key aspects of pharmaceutical production is ensuring high-quality standards to ensure the safety and efficacy of these products. In... February 28, 2023Read more
0Good Distribution Practice (GDP)Knowledge BaseLicensing in the European UnionGDP for transportation companies of medicinal products (without storage) September 7, 2022Read more
0Knowledge BaseQuality System ElementsConducting in-depth investigations during GMP/GDP audits August 22, 2022Read more
0Knowledge BaseLicensing in the European UnionNational Regulatory Authorities in the EU (competent authority) August 19, 2022Read more