Production Auditing

FormaliS conducts audits of production sites to check compliance with regulations and study plans, as well as to assess the reliability and quality of the data.

Activity:

  • Auditing according to cGMP, Annex 13 to GMP or ISO standards
  • Feasibility audits
  • Site audits
  • System audits
  • Report audits

Scope:

  • Production, packaging and distribution of clinical study batches
  • Specific assignments

Standards:

  • current Good Manufacturing Practice (cGMP)
  • Annex 13 to GMP
  • Local Regulations
  • Biosafety Guidelines for Biotech
  • HACCP for Food Processing