GMP Consulting
Your specific situation is always the starting point. Your business considerations form the basis for our ideas.
Our collaboration begins with an analysis of the current circumstances, which then serves as the foundation for implementing the subsequent steps:
- Establishing or adapting the Quality Management System (QMS)
- Developing SOPs, a QM Manual, and a Site Master File
- Planning and conducting self-inspections
- Qualifying the supply chain and coordinating audits
- Supporting regulatory inspections
- Tracking and resolving inspection findings
Diapharm can provide advisory support at every stage or fully assume regulatory functions in accordance with the Medicinal Products Act.
Audit Reports Available for Purchase
GMP-compliant active substance manufacturing is ensured through GMP audits. Diapharm conducts independent, high-quality GMP audits for manufacturers of active substances, raw materials, and packaging materials, offering companies a cost-effective alternative to in-house audits through third-party audit reports. Diapharm manages the entire process—from preparation to CAPA plan follow-up—including all necessary agreements and documentation.
