Services Provided

  • Specialized in auditing plants in Asia and Europe
  • Full GMP Audits according to EU Guidelines, US 21 CFR 210 and 211 and ICH Q7
  • Audit API manufactures and Finished Dosage Form manufacturers
  • Audit of Key Starting material plants and Excipients manufacturers
  • Audit follow-up to address the observations
  • Spot Checks
  • Preparing plants for EDQM / EU Authority audits
  • Accompanying EDQM / EU Authority auditors to plants to assist in the audits
  • Assisting manufacturers to fulfil GMP, provide GMP training to employees
  • Visiting manufacturers within 24 hours to solve problems
  • Setting up Corrective Actions and implementing Preventive Actions
  • Sample drawing and arranging independent laboratories to test
  • Transferring analytical methods
  • Aiding manufacturers to improve the quality of the product Work with the plants to transfer products from pilot to production scale
  • Aiding plants to establish and maintain a DMF or CEP
  • Performing Due Diligences
  • Translations during audits