Good Manufacturing Practice Standards

MQI provides GMP-compliant regulations for manufacturing, processing, packing or holding of pharmaceuticals or medical devices.

We implement:

• Overall development and implementation of current Good Manufacturing Practice (cGMP), Q7A and Quality System regulation for finished pharmaceutical and medical device products and Active Pharmaceutical Ingredients (API)
• Quality units, including QA and QC
• Personnel qualifications and training
• Facility qualification and operations that are compliant with regulatory standards
• Instrument and equipment qualifications
• Validation of manufacturing processes and QC methodologies
• Quality audit and audit reports
• Regulatory submissions (e.g., DMF, CMC, annual quality reports)
• Pre-approval inspections and FDA inspection facilitations
• Ongoing guidance for overall regulatory issues and quality compliance