Quality Assurance

Quality is not just another goal; it is our basic strategy for future growth. Compliance is implemented at all levels of the organization from manufacturing and testing, to shipment of product to the customer. Our manufacturing facility is regularly inspected by leading global (MHRA) and domestic (FDA) regulatory agencies and has an excellent inspection history.

Our Quality Assurance service comprises three divisions: Manufacturing Quality Assurance (MQA), Incoming Quality Control (ICQ), and Document Control. These departments are responsible for the following:

  • The inspections of all incoming components and raw materials to ensure adherence to specification requirements
  • Performing Line Clearance and AQL inspection throughout batch production and packaging processes
  • Final review of all documentation
  • QC testing
  • In-process testing prior to final product release/li>

Our Quality Management System is based on the requirements of:

  • 21 CFR Parts 210 and 211: cGMP for Drugs and Pharmaceuticals
  • 21 CFR Part 820: Quality System Regulation for Devices
  • Medical Device Directive 93/42/EEC
  • EU GMPs, EU Annex 9

Services:

  • Creation of Component Specifications
  • Raw Material Specifications
  • Product Testing Specifications (bulk, finished and stability)
  • Methods Testing
  • Certificates of Conformance
  • Certificates of Analysis
  • Annual Product Reports
  • Provide Vendor qualification as well as contract lab and manufacturer qualifications