OR WAIT null SECS
January 02, 2024
Analytical methods and tools play a pivotal role in cleaning validation.
Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.
December 18, 2023
Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.
December 15, 2023
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
December 04, 2023
The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.
December 02, 2023
Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.
The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.
Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.
November 20, 2023
Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.
The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.