Searched for GMP audits? GMP auditing is a process where we ensure you that the production facility, processes and controls is operating in accordance to the Good Manufacturing Practice (GMP) as defined in ICH Q7A, Eudralex Vol. 4 and ECC Directive 2003/94/EC. When performing GMP audits, we are providing an examination of the overall manufacture chain and controls.

When doing GMP audits, we inspect all critical aspects of the production and we adhere to quality standards available to date, thereby ensuring regulatory compliance of the active pharmaceutical ingredient (drug substance) and the medicinal product regardless of the being investigational or commercial.

Why GMP audits are crucial for your company?

For the sponsor of clinical trials or the Market Authorization holder, it is mandatory and the responsibility to make sure that the products are manufactured and controlled per current GMP. An essential tool for doing this is to perform high quality and thorough inspections/audits. It is recommended that audits are performed as part of the final evaluation of the CRO/CMO and before signing of the business agreement, and that follow up audits are performed on a regular basis and in close connections to actual service being performed.

GMP audits as a safety measure for the patient

By thoroughly auditing the production and control process you can ensure confidence in creating a safe and high quality product, and in compliance with GMP.

Our auditing creates a high efficiency environment for your team, so that you all can work safely and manufacture your product in the best possible way – and strengthen your company from the bottom up.

 

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