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November 02, 2020
Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.
October 20, 2020
FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.
October 16, 2020
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.
October 15, 2020
Consistent product quality requires a clear understanding of the essence of CGMPs. Experts fear that the message is not always getting through to compounders.
The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.
October 02, 2020
A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.
Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.