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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.
February 15, 2017
The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.
Baricitinib (Olumiant) is the first JAK inhibitor licensed to treat rheumatoid arthritis in Europe.
February 13, 2017
Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.
February 10, 2017
EMA announces that the European Union’s PAS Register has received its 1000th upload.
Pharmaceutical Technology spoke with Tommy Fanning, head of biopharmaceuticals for IDA Ireland, to get a perspective on how Brexit may affect the pharmaceutical industry.
February 09, 2017
The company is voluntarily recalling product due to particulate matter.
February 07, 2017
FDA's Warning Letter to an Indian API manufacturer alleges cGMP violations and improper cleaning and validation
February 02, 2017
Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.
Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
The warning letter cited GMP violations for finished drug products.