Quality Assurance: Audit

GMP, GDP, GVP Quality Systems & SOPs

Designing and managing a quality system is time consuming and requires comprehensive knowledge.

Especially smaller enterprises, who do not employ designated Quality Assurance personnel, will benefit from our external and on-site Quality Assurance services:

  • Services as Head of Quality Assurance, GDP Responsible Person or German Großhandelsbeauftragter (§52a AMG)
  • Designing and optimising efficient Quality Systems
  • Managing application procedures for manufacturing authorisations (GMP) and wholesale distribution authorisations (GDP)
  • Preparing SOPs according to your requirements
  • Advise regarding IT systems for SOP management
  • Performing self inspections and audits


Quality Systems

The Quality System of a pharmaceutical company needs to cover all areas with a direct influence on product quality and patient safety and should be designed in accordance with applicable guidelines:

  • Manufacturing: Guidelines on Good Manufacturing Practice (GMP) 
  • Distribution: Guidelines on Good Distribution Practice (GDP)
  • Pharmacovigilance: Guideline on Good Vigilance Practice (GVP)

All activities should be documented with adequate detail in written Standard Operating Procedures (SOPs).