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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
May 15, 2017
The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
May 11, 2017
FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.
May 10, 2017
At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.
May 09, 2017
FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.
The company is expanding their April 2017 voluntary recall of phenobarbital tablets.
The agency released its report on pilot project to involve patients in the assessment of medicines.
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
May 08, 2017
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.