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As a part of regulatory requirements, we prepare numerous documents. Preparing documents shall not be treated as a burden but shall be considered as an activity of creating proofs or evidences that shows one’s true self. There are many types…
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…
Manual Visual Inspection is an important step in pharmaceutical manufacturing which aids in the detection of various formulation defects. The defects are observed in the all types of formulations viz. tablets, capsules, injectables etc. To effectively observe the defects there…
Oct, 24 2020 Gilead Lifesciences Inc.'s Veklury (Remdesivir) has become the first treatment for COVID-19 to receive the U.S. Food and Drug Administration approval. The drug is approved for use in adult and pediatric patients 12 years of age and older…