MicroRite specializes in providing comprehensive consulting and training services focused on Good Manufacturing Practices (GMP) for the pharmaceutical, biotechnology, and medical device sectors. The company emphasizes a risk-based approach to contamination control, which is essential for ensuring product and patient safety. Their services include the development of Overall Contamination Control Strategies (CCS), which are critical for assessing the effectiveness of control and monitoring measures across facilities. This strategy is aligned with international guidelines such as ICH Q9, Q10, and EU regulations, making it a necessary component of modern quality management systems. By fostering collaboration between various departments, MicroRite enhances awareness and preparedness for regulatory inspections.

In addition to contamination control strategies, MicroRite offers a range of specialized services including cleanroom validation, microbiology quality assurance, and analytical quality control. They utilize advanced techniques such as Computational Fluid Dynamics (CFD) for airflow visualization and contamination troubleshooting, which are vital for maintaining cleanroom environments. Their expertise extends to areas like sterilization consulting, risk-based environmental monitoring programs, and mock regulatory audits, ensuring that clients are well-equipped to meet compliance standards. Through training programs, workshops, and ongoing support, MicroRite aims to instill a culture of continuous improvement and proactive risk management within organizations.

United States

Microrite is a San Jose, CA based Consulting and Training Company helping Pharmaceuticals, Biotechnology , Medical Devices and Drug-Device Combination Products in the areas of Quality Assurance, Quality Control, Microbiology, Process Development, Process Validation, Facility and Utility Validation.

MicroRite

Company Details