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Supplier Audits & Source Inspections

FST designs and performs supplier audits and source inspections as a 3rd party to give you peace of mind when working with suppliers to assure that standards and specifications are being met.

Audits often include an on-site visit with traceability proof, personnel certification records, internal audit records, and calibration records along with a myriad of other record checks throughout the process.

  • Semiconductors

    SEMICONDUCTOR

  • Life Sciences

    LIFE SCIENCES

  • R&D

    R&D

  • Energy

    Energy

  • Data Centers

    Data Centers

In the life sciences market for pharmaceuticals, some audit specifications to consider are:

  • US FDA 21 CFR 210 & 211
  • IPEC Guidelines
  • EudraLex Requirements
  • PIC/S GMP Guide
  • ICH Q7 GMP Guide for APIs
  • ICH Q10 Pharmaceutical Quality Systems
  • WHO GMP Guidelines
  • PS 9000:2016 Pharmaceutical Packaging

Many ISO standards require secondary supplier audits every 2 years.