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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.
April 02, 2016
A global API marketplace increases the burden of supply chain monitoring for drug companies.
The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
Global outbreaks energize vaccine R&D and drive production modernization.
Pharmaceutical Technology spoke with FDA to get the agency’s insights on how the industry can ensure quality in solid and semi-solid dosage products.
The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.
April 01, 2016
The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.
The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.
Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.
March 29, 2016
Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.