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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.
September 01, 2017
Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
QbD principles and strategic thinking can reduce the time required to optimize formulation.
August 31, 2017
The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).
August 30, 2017
An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.
August 28, 2017
High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.
FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.
FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.
FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.
August 24, 2017
The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.
The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.