10.05.2021

What are the powers of the GMP inspectors in inspections?

According to Directive 2001/83/EC, Article 111, the powers of the competent authority are:
• Inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorisation with the task of carrying out checks pursuant to Article 20
• Take samples
• Examine any documents relating to the object of the inspection 

[GMP Compliance Adviser, Chapter 21.B]