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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.
October 02, 2016
Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.
As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.
September 30, 2016
Could grading finished-drug manufacturers on their quality and efficiency lead to greater transparency, improve quality and reduce drug shortages?
September 27, 2016
Employee empowerment is needed and it begins with senior leaders making adherence to cGMP regulations and compliance with SOPs the normal, easy, and rewarding thing to do.
September 26, 2016
FDA and EMA set up new working group on the development of treatments for rare diseases.
September 23, 2016
Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.
Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.
NICE estimates asfotase alfa will cost £367,000 per patient per year.
September 22, 2016
The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.
September 21, 2016
The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.