GxP Audits are at the heart of the pharmaceutical, clinical, and distribution sectors. Our specialized audit solutions ensure your operations align with the highest standards of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP) and Good Automated Manufacturing Practices (GAMP).
We navigate the complexities of regulatory expectations with precision, offering meticulous internal / external audits, robust supplier / vendor evaluations, and tailored quality management assessments.
Whether enhancing your readiness for health agency inspections or optimizing your quality systems with expert consulting, our commitment lies in empowering your business with the tools for corrective and preventive action success.
Trust Asphalion to transform your compliance challenges into opportunities for growth and innovation.
Focus:
Internal / External Audits:
Supplier / Vendor Audits:
Our service:
Audits can be conducted either onsite or remotely, maximizing precision and compliance with applicable regulations in each area of the product lifecycle.
GxP Audits Solutions
We ensure that manufacturing processes comply with the most stringent quality standards. Our audits cover everything from the review of Active Pharmaceutical Ingredients (APIs) and excipients to finished products. For APIs, we verify specifications, test methods, and impurity controls. When it comes to excipients, we evaluate quality management and manufacturing processes. We also focus on finished products and both primary and secondary packaging materials, ensuring compliance with GMP and ISO standards.
We safeguard the quality of pharmaceutical products throughout the supply chain. The audits ensure proper handling of storage, transport, and rotation of medications, as well as the prevention of cross-contamination. Our auditors are knowledgeable about local and regional regulations to ensure that products reach their destinations safely and in compliance with regulations.
We assess the standards by which clinical trials are conducted to ensure patient integrity and well-being. We verify that clinical sites comply with relevant regulations, clinical protocols, and necessary ethical principles.
We review the integrity of data from non-clinical studies. The evaluations range from the inspection of ongoing studies to follow-up audits of subcontracted laboratories, ensuring strict adherence to protocols and regulations.
We certify that laboratories involved in clinical testing adhere to regulations, thereby supporting marketing authorizations by ensuring that the data is reliable and well-documented.
We affirm the efficiency of pharmacovigilance programs through comprehensive audits covering drug effect surveillance post-licensing, operational audits, and reviews of data management systems.
We assess the standards by which GxP computerized systems can be validated to achieve regulatory compliance regarding patient safety, product quality, and data integrity.
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