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We understand our clients want raw materials they can rely upon to give them the quality they need to develop their products.

Talk to one of our account managers about our thorough testing and regulatory processes.

Quality

Our qualification process includes reviewing areas such as:

  • quality management systems
  • process equipment
  • materials management
  • quality control of starting materials
  • production systems
  • validation systems
  • laboratory testing
  • product release
  • storage
  • distribution systems
  • accreditation by recognised authorities
  • collection of supporting documentation

Vendor Assurance Testing

  • The vendor surveys and supporting evidence is reviewed by our in house Technical & Regulatory Manager, who together with the supplier works through each response until all answers have been completed correctly.
  • The vendor assurance is carried out in compliance with the requirements of our local Australian regulatory bodies, such as the TGA.
  • Vendor qualifications are reviewed on an ongoing basis to ensure they are kept up-to-date with recent supporting documentation.
  • Any changes in manufacturing processes or changes in manufacturing sites are captured by our vendor qualification process to ensure these are as up to date as possible.
  • TransChem clients gain immediate access to the pre-qualification information, including full technical documentation packages and vendor audits, so they need to check compliance with their own quality standards.

TransChem’s Vendor Qualification helps our clients bring new products to market in a shorter timeframe.