Guidelines on General Principles of Process Validation, FDA, (May 1987). Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology, FDA (April 1985). Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characteriza...

Quality Systems Product Quality & Specifications Product & Process Development Technology Transfer Contract Research & Development Pre-clinical & Clinical Studies Equipment Qualification & Re-qualification Process & Analytical Methods Validation Cleaning & Shipping Valida...

Our competent and highly experienced professionals have expertise with a variety of computer systems (hardware and software) employed in automated or semi-automated equipment systems, analytical instruments, operational systems, data management systems, etc. These include: DCS, PLCs, LIMS, SCADA, ME...

Ambicon offers a wide range of equipment installation, commissioning, qualification/re-qualification, validation/re-validation, and technology transfer services to start-up and licensed biopharmaceutical, diagnostic and vaccine manufacturing companies. We define the scope, timelines, deliverables an...

Typical Activities: QC Analytical and Instrument Qualification (IQ/OQ/PQ) Computer and Lab Software Qualification (IQ/OQ/PQ) Analytical Methods Development Report (MDR) Analytical Methods Qualification (Report) System Suitability Studies for Compendial Methods Analytical Methods Validation (Protocol...