OR WAIT null SECS
December 12, 2013
Teva Pharmaceutical Industries releases a financial outlook for 2014 based on two possible scenarios concerning its multiple-sclerosis drug Copaxone (glatiramer acetate).
December 02, 2013
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
Brian Galliher of Cook Pharmica discusses visual inspection systems.
The industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
November 20, 2013
An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.
November 07, 2013
Includes a new approach on developing antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options.
November 05, 2013
FDA releases guidance on pulmonary tuberculosis drugs.
November 04, 2013
EMA and FDA publish joint QbD guidance on design space verification.
November 02, 2013
Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.
Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.