GMP/GDP AUDITING

We provide full-scope Good Manufacturing and Distribution Practice Services to ensure your compliance with the relevant EU and CIS legislation.

We provide consultancy on all aspects of GMP and additional QP-services. This is an external “Qualified Person” (QP) – that is a competent person who carries out the regular work and takes responsibility in accordance with § 14 AMG on a freelance basis.

• Services of Qualified Person
• Third Party Service set up for batch release
• Quality Systems set up and review
• Writing of SOPs and other documents
• Auditing
  • Preparations for GMP, GDP audits and inspections
  • Third party GMP audits of API manufacturers
  • GMP inspections arrangement from health authorities
• Training
• GMP API audit reports