Quality Management

The Quality Management System (QMS) based on EU GMP guidelines serves as the foundation of any pharmaceutical company. At Saidia, we collaborate with our clients to introduce and incorporate innovative technologies that enhance the efficiency of their processes.

Implementing & Managing the QMS

Depending on your specific requirements, we will set up the whole pharmaceutical quality system for all processes in accordance with ICH Q10 or support you in designing and implementing the QMS by reviewing and optimizing existing systems. We are happy to support you with:

• Preparation of the Quality Manual
• Creation of Standard Operating Procedures (SOPs)
• Implementation of employee training
• Provision of important documents e.g., contracts or job descriptions
• Investigation of complaints & returns as well as finding suitable measures
• Implementation of (mock) recalls  
• Definition & implementation of Corrective And Preventive Actions (CAPAs).
• Implementation of an appropriate Change Control Management
• Establishment of a Quality Risk Assessment
• Development of the Quality Management Review
• Qualification & validation of your QM systems
• Implementation of the Good Manufacturing Practice (GMP) & the Good Distribution Practice (GDP)
• Provision of the Responsible Person GDP (Großhandelsbeauftragter) according to §52a AMG

Audits & Inspections

Our experienced auditors assess the GMP and GDP compliance of your manufacturing and distribution processes and perform mock inspections if required. Moreover, we will assist you in preparing for inspections and provide support throughout and after the regulatory authority inspection. Saidia stands by your side, offering unwavering assistance until the desired permit is obtained.