Quality Assurance

At Microrite we look at quality assurance of healthcare products as a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. Using this totality of arrangements we make sure that pharmaceutical products are of the quality required for their intended use.

• Design and Implement Quality Systems
• Establish Quality Plans
• Quality Risk Management
• Quality Mapping
• GAP Analysis
• Quality policy and objectives
• Quality System Analysis and Improvements
• Establish Risk Management Programs
• Quality system upgrades to new standards and requirements
• Quality Investigations
• Corrective and preventive actions (CAPA)
• Failures, deviations, and out of specification (OOS) investigations
• Preparation for Pre-Approval Inspections, routine FDA Inspections and State licensure Inspections
• Internal, External and Vendor Audits
• Standard operating procedures (SOP) and forms
• Regulatory documentation preparation
• Establish quality agreements and service agreements with CMOs
• Technology Transfer Documentation
• Data compilation, review and reports for regulatory filings
• GMP Training