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Pharma is a highly regulated industry. Regulatory audits are an integral part of the drug regulations. Any pharmaceutical industry having a global presence undergo numerous audits in a year by various regulatory agencies. This not only affects their productivity but…
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…
No manufacturing firm can design a process where they don’t need to hold the various dispensed, in-process, bulk and finished products for few hours to many months. The duration for which the various materials can be hold under specific environmental…