Quality and Laboratory Systems
Pharmaceutical and Laboratory Compliance, Data Integrity, Justification documents, Procedures (e.g. SOPs) and Guidances, Expertise in EP/USP/JP/BP/ISO, IT systems to support the clients's Business processes, Improvement and Restructuring to gain the Business targets, Cost Reduction, Training.
We’ve been fortunate to gain the knowledge and expertise in various fields of pharmaceutical and related industries and we continue to get more knowledge and stay being continuously updated
SOPs, Guidelines
Improving Quality Units/Laboratory Processes through the creating efficient and compliant Standard Operating Procedure or Guidance. Creating the new one when you are required to be in compliance with the current regulatory requirements. Few examples: Elemental Impurities; Unknown peaks in Chromatography, Validation of analytical methods etc.
Validation Documents
Creating Validation Protocols and Reports, Verification/Suitability and Equivalency Reports requires good understanding analytical chemistry behind the procedure as well as the regulatory requirements the procedure should stand in, e.g. HPLC/GC, Titration, Water Determination by Karl Fisher etc.
Processes Improvements, Cost Optimization
Inefficient processes effect the Service Level, Product Cost, Compliance etc.
That might be derived from, for example, IT systems, Data Integrity gaps, not finding the root causes for Investigations, wrong or inefficient KPIs (department key performance indicators), cumbersome internal laboratory processes ("Operational Excellence"), insufficient Reduced Testing, insufficient understanding in Quality and Laboratory Expenses and how to decrease them, poor implementation PAT (process analytical technology) etc.
Get in touch
Zvulun Hammer 5, Giv'at Shmu'el, 5442313, Israel
+972 (0) 54 8882625