Pharma – Compliance

All pharmaceutical companies are subject to regulatory requirements if the products are put be sold on the European or American market. AL Engineering offers assistance to some of the many tasks, including:

  • Audit (internal and external)
  • Compliance with EMA and FDA requirements
  • Design control
  • IT & automation
  • Environmental monitoring of clean rooms
  • Risk analysis
  • Validation / qualification
  • Commission

The pharmaceutical industry is regulated within the EU, for example. of :

  • EU Directive 65/65 / EEC1
  • EU Directive 75/318 / EEC
  • EU Directive 2001/83 / EC
  • EU Directive 2005/28 / EC

Similarly, pharmaceutical industry within the US is regulated, for example. of:

  • FDA 21 CFR Part 11
  • FDA 21 CFR Part 58
  • FDA 21 CFR Part 210
  • FDA 21 CFR Part 310

Contact

John Albertsen

+45 2123 5168