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Medistri’s SwissMedic GMP Compliance

28 October 2024

(Download: Medistri’s SwissMedic GMP Compliance in PDF by Medistri)

Good Manufacturing Practices (GMP) are vital standards in the pharmaceutical industry that ensure product quality and safety throughout production. These regulations protect against contamination, errors, and deterioration, ensuring that healthcare products consistently meet strict standards.

GMP focuses on controlled environments, accurate record-keeping, and validated production procedures. It also emphasizes the importance of well-trained staff, ensuring everyone involved follows the required processes. Equipment must also be calibrated and validated to maintain consistent quality.

To achieve the high standards set by GMP, several fundamental practices are essential for driving quality and safety:

  • Documentation: Every step in the process is recorded to ensure traceability and accountability, allowing for quick resolution of issues and fostering improvement.

     

  • Continuous Improvement: Regular audits not only help manufacturers refine processes and adapt to advancements, keeping them compliant with changing standards, but they also improve the connection between team members through ongoing training and skill development at Medistri. With the support of digital tools like Dynamics, our teams enhance their competencies and strengthen collaboration, ensuring quality and efficiency across operations.

     

  • Supplier and Material Management: GMP requires strict selection and verification of suppliers and materials, ensuring that only high-quality inputs enter production, minimizing the risk of defects or contamination.

SwissMedic, the Swiss Agency for Therapeutic Products, ensures that manufacturers comply with GMP guidelines in Switzerland. Regular inspections verify that production facilities meet high standards of quality, safety, and efficacy.

At Medistri, we fully adhere to GMP regulations. Our risk management, quality control, and continuous training programs ensure consistent, safe production. Our Quality Management System (QMS) monitors all processes, guaranteeing traceability and preparing us for audits.

We also focus on sterility and hygiene, especially in sensitive product areas like injectables. Strict controls maintain sterile environments and ensure proper hygiene. Additionally, we use Quality Risk Management (QRM) to identify and reduce any risks, maintaining consistent and safe production.

Medistri’s commitment to GMP ensures that we deliver high-quality products while keeping patient safety and product integrity as our top priorities.

🎯 To learn more about Medistri's GMP Compliance, visit our website here or directly contact our team at contact@medistri.swiss.

— The Medistri Team

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