Which standards and guidelines play a role in the GMP environment?
Overview of the most important regulations in the GMP environment:

• National regulations for Germany: Medicinal Products Act (AMG) / Medicinal Products and
  Active Ingredient Manufacturing Ordinance (AMWHV)
• EU regulations: EU GMP Guidelines Part I-III incl. Annexes
• US regulations: FDA Code of Federal Regulations (CFR)
• International regulations: ICH-Guidelines, PIC/S-Guides, ISPE Guides

Which industries operate in a GMP-regulated environment?
These industries must comply with GMP guidelines and standards:

• Pharmaceutical industry
• Medical technology
• Life Sciences & Biotechnology

What requirements must GMP-compliant documentation meet?

• It must be in writing.
• It must be correct and complete.
• It must be clearly formulated and always kept up to date.
• It must always be available.
• The documentation must be approved and signed by the responsible quality officer.

How is risk management defined in the ICH Q9 guideline?
The risk management process is described in the ICH Q9 guideline, which is firmly anchored in Part III of the
EU GMP guideline. Its aim is to establish a comprehensive process of risk assessment, control and monitoring throughout the product life cycle in order to bring potential errors and hazards to product quality under control. Many of these measures are determined in the course of risk analyses (e.g. FMEA) and implemented in the course of qualification and validation implemented. In the GxP environment, this is often referred to as risk-based qualification and risk-based validation.