Quality Indicators from an API manufacturer perspective

01/06/2021

Ms. Mariona Senis, Quality Director of Medichem, S.A., participated as a guest speaker in the training program on Indicators of the Quality System and Continuous Improvement in Pharmaceutical Laboratories Manufacturers of Medicines or Active Ingredients offered by the Continuous Training Institute of the Universitat de Barcelona (IL3-UB) 

The presentation addressed the program of indicators proposed by the FDA in the guideline Submission of Quality Metrics Data_ Guidance for Industry and its relationship with the concept of maturity of the quality systems (QMM) and the pilot program initiated by the FDA to assess the degree of maturity of the quality system of foreign active pharmaceutical ingredient manufacturers.