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There is a popular phrase that says “Mistakes are bound to happen”, so do the non-conformances in the pharmaceutical manufacturing. Even if you have validated processes, qualified vendors, qualified equipment, calibrated instruments, in-process checks, SOPs etc. in place, possibility of…
One of the basic expectations of Quality Management System is to carry out Self Inspection to assess the level of compliance. Carrying out Self Inspection is mandated by almost all the regulators in the world be it USFDA, EU,…
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. What has made the matters worse is the mental stress developed due to fear and anxiety of looming uncertainty. This may…
March 31, 2020 EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic…
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. Till now, this deadly disease has taken lives of more than 35000 people and more than 750 thousand people are infected…