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Going by the classical definition, an impurity can be defined as an unwanted chemical substance which differs from the chemical composition of the material in question. In pharmaceutical preparations, impurities identification, assessment and quantification play a vital role in evaluating…
Pharmaceuticals in general not only produce drugs but they also produce tons of data. Regulatory agencies across the globe insist on generation of data for each and every activity. We should understand that there is value in data generation. Data…
Pharmaceutical products are manufactured with an objective of meeting their predefined objectives of quality, safety and efficacy. However, how hard we try, still there is a possibility of physical product defects that may occur during the entire process of manufacturing…
Principles of Quality Risk Management found their application in our day to day life, apart from their application in the industry, production, regulations etc. In pharmaceutical industries principles of QRM found their application for both manufacturers as well as reviewers/…
Every pharmaceutical manufacturer, or let us say manufacturer of any goods, want to manufacture a product of best quality which shall complies with all the applicable regulations, guidelines, specifications etc. In pharmaceuticals, this becomes a bigger challenge as the failure…