Azimuth-Quality

Consulting services for the life science industry We at Azimuth Quality offer you sound engineering quality know-how for the implementation or improvement of the entire technical quality concept, from projects and initial site releases to routine manufacturing and routinely recurring tasks. We advise you on the choice of different possible strategies and help you achieve your goals in a lean and compliant way, respecting your company culture and journey. Consultancy and Concepts -Design and implementation of lean, but compliant, Commissioning/ Qualification/ Validation Strategies (C&Q Master Plans & VMP’s, Policies, and SOPs as well as ongoing programs)- Risk Assessments (Qualification, Process, Contamination and Containment, Maintenance)-Gap Assessments (Compliance and Process)-QMS implementation and improvements -Engineering Quality, Maintenance and Calibration Strategies -Process Performance Qualification / Process Validation -Ongoing Process Verification Programs -Contamination Control Strategies -Disinfection Efficiency Studies -Sterility Expertise (Sterilization and Depyrogenation)-Product Changeover Monitoring -Environmental Monitoring -Audit Preparation & Participation Qualification and Validation Execution Equipment and Process for Biotechnology (upstream and downstream), Aseptic and Sterile Fill Finish Facilities, Solid Oral Dosage Forms, Liquids, Creams and Ointments, API manufacturing, blood-based products, and Live Biological Pharmaceuticals-Cleanrooms, Isolators and BSC’s -Media and Gases -Equipment - Including Cycle Development, Riboflavin Testing, and Mapping -Computer System Validation -Cleaning Validation & Hold Time Studies -Requalification and Periodic Reviews