Regulations and Standards

Regulations and Standards

Working many years in the life science industry in Quality & Regulatory Affairs, I have an extensive knowledge and experience in different regulations and standards.

  • Medical Device Directive & Regulation
  • FDA (US Food & Drug Administration Requirements) – including part 820 for Quality System Regulation
  • US Pharmacopeia – focus on primary plastic packaging
  • European Pharmacopeia with focus on primary plastic packaging
  • European Food Law – focus on plastic packaging
  • cGMP – Good Manufacturing Practice
  • ISO 9001 - Quality Management
  • ISO 15378 - Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
  • ISO 13485 - Medical devices -- Quality management systems -- Requirements for regulatory purposes
  • ISO 31000 - Risk Management
  • ISO 14644 - Cleanrooms and associated controlled environments
  • ISO 14698 - Cleanrooms and associated controlled environments – Biocontamination control
  • ISO 8573 - Compressed Air
  • ISO 2859 - Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
  • GAMP 5 -  Good Automated Manufacturing Practice

If your need is not covered by the listed standards, please feel free to contact me to check my knowledge and experience on your specific requirements.