GMP and ISO compliance audits
Execution of GMP-Audits is the basis for system evaluation through pharmaceutical manufacturer, independently whether an internal department, a customer or a supplier is focused.
Valicare’s long term experienced and certified auditor team will support you with knowledge and high motivation regardless whether you are in preparation on internal, external, third party audits or authority inspections. GMP and ISO quality compliance of systems, products, processes and documentation systems is checked on the basis of international requirements, guidelines and harmonized standards (AMWHV, EU-GMP, ICH Q7, ICH Q10, PIC/S, USP 32 ˂1078˃, EN ISO 9001, EN ISO 13485).
We have the know-how to analyze production processes of the pharmaceutical, medical device and biotechnology industry (with a core competence regarding ATMPs) by our own audit team.
Services for Audits and Inspections
ISO and GMP Compliance Audits
Valicare provides support on the following subjects:
- Preparation, accompany or execution of internal and external audits (qualification-, routine- or for-cause audits)
- Third party audits such as supplier qualification of raw materials, APIs (active pharmaceutical ingredients), excipients and intermediate manufacturers as well as for equipment suppliers and contract manufacturers, service providers and contract testing laboratories
- Follow-up audits
- Gap analysis by independent GMP experts to check your existing systems on GMP compliance
- Preparation and accompany of authority or FDA inspections
- Mock inspections
All results, findings and deviations if observed, will be documented accurately, exactly and objectively in an audit- or analysis-report and discussed in detail.
Corrective and preventive actions (CAPAs) are defined if required. Suggested corrective measures are checked with professional expertise and their implementing ensured through follow-up audits.
Expertise and independency of our professional experts assure the truthfulness and objectivity of their statements, appraisals and reports.
The benefits of choosing Valicare GMP experts is a deeper understanding for GMP compliance requirements and more calmness and sovereignty in handling of audits and inspections.