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).