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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.
March 15, 2020
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.
March 10, 2020
The agency is postponing the inspection of most foreign facilities through April 2020.
March 05, 2020
The organization is postponing its annual meeting to July 2020 because of the developing COVID-19 outbreak.
FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.
A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.
March 02, 2020
States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.
Emergency action to protect patients and the drug supply may have long-term implications.
No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.
Tackling process development early on can better optimize manufacturing processes for emerging therapies.