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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 02, 2017
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
FDA works with industry on strategies for assuring high-quality regenerative medicines.
Forced degradation studies can identify stability problems for drug substance and drug products.
When it comes to getting the best out of quality by design, timing is everything.
EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.
September 01, 2017
Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.
FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.
A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.
Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
Implementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.