Audit
Thorough quality assurance – tailored to your needs.
At Herlev Pharma Service, we provide professional audit services in compliance with EU-GMP, ISO 13485, ISO 9001, GMP, GDP, and GCP.
We conduct both supplier and internal audits, ensuring that all relevant quality parameters are reviewed and documented.
Quality Assurance Throughout the Audit Process
Audits are an integral part of GMP quality assurance and help ensure that your business partners comply with applicable requirements.
We work closely with you and tailor the audit process to your organisation, quality needs, and specific regulatory requirements.
The Audit Process – Four Steps
We manage the entire audit process, from initial preparation to reporting and follow-up.
01
Preparation
We define the scope and requirements of the audit, review relevant documentation, and prepare the audit plan and schedule.
02
Audit
We review facilities, documentation, and processes and interview relevant employees.
03
Closing Meeting
We review our observations and preliminary findings with you and clarify any deviations.
04
Report & Recommendations
We prepare an audit report detailing our findings and recommendations and follow up on the next steps.
Remote and On-Site Audits
We offer both remote and on-site audits, depending on your specific needs, risk assessment, and quality history. Our flexible approach ensures that the audit process is tailored to your organisation while maintaining high standards of quality and compliance.
In certain cases where a more thorough review is required – for example, for complex processes, new suppliers, or specific regulatory requirements – an on-site audit will be necessary to ensure full compliance with applicable guidelines.
Do You Need Audit Support?
Let’s discuss your needs and identify the audit solution that best suits your organisation.