A number of regulatory requirements are based on the approval of the U.S. Food and Drug Administration (FDA), the World Health Organisation and the European Union.

International approvals for SOP management systems (selection):

  • FDA 21 CFR (Code of Federal Regulations)
    • Part 11 (electronic records, electronic signatures)
    • Part 210/211 (current GMP)
    • GFI (Guidance for Industry) and Rules
  • GAMP 5
  • WHO Guidelines
  • Recommendations of PIC/S (Pharmaceutical Inspections Convention)
  • ICH (International Conference on Harmonisation)
  • European principles and  guidelines of good manufacturing practice for medicinal products for human use
  • The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 11: Computerised Systems
  • additional guidelines


Federal approvals for SOP management systems (selection):

  • German Drug Law (AMG)
  • German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV)
  • Chapter 2, general requirements, section 10 (general guidelines on documentation)
  • Chemicals Act (ChemG)
  • General Administrative Provision GLP (ChemVwV-GLP)
  • German Civil Code
  • Digital Signature Act (SigG)

Certified companies also try to make sure that they meet general DIN ISO quality management requirements. The current guidelines are available on the websites of FDA, EU, the German Federal Ministry of Health and the German Federal Ministry of Justice.

Back to Guidance and Regulations on SOP management systems