Quality Management System: GMP, GDP
Planned, implemented, and successfully inspected.
Diapharm supports clients with planning and documentation, preparing for audits and inspections, adapting to changing regulatory frameworks, conducting compliance checks for manufacturing processes, and much more:
- GMP consulting and gap analyses for pharmaceutical companies
- Establishing a QMS according to EU-GMP/GDP guidelines
- Developing Standard Operating Procedures (SOPs), QM Manuals, and Site Master Files
- Auditing and modernizing quality management systems
- Performing self-inspections
- Supporting regulatory inspections and follow-up activities
- Assuming statutory responsibilities according to the German Medicinal Product Act
Tailored, GMP-compliant Quality Management
Diapharm ensures that pharmaceutical companies have a QMS that fits their specific needs. Standard Operating Procedures (SOPs) are designed to reflect each company’s individual workflows and make daily operations easier through standardization — practical and efficient.
In addition to QMS and GMP/GDP consulting, Diapharm can also assume roles within your QMS as needed, such as acting as Quality Management Representative.
